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EC number: 205-760-9 | CAS number: 150-46-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Trimethyl Borate was tested in an in vivo skin irritation/corrosion study (non-guideline) and an in vivo Acute Eye Irritation / Corrosion study (OECD 405).
Skin Irritation:
Primary Irritation score is 0.5
Based upon the data obtained, Trimethyl borate would not be considered a primary skin irritant
Eye irritation:
The Maximum Average Scores (MAS) were calculated to be:
0.1 ml /right eye, unwashed - 34.5 at 48 hours
0.1 ml /right eye, washed - 43.0, at 48 hours
based upon data obtained, Trimethyl borate would be evaluated as follow:
0,1 ml/right eye, unwashed - is a primary eye irritant
0,1 ml/right eye, washed - is a primary eye irritant
Trimethyl borate was evaluated as primary eye irritant and classified as moderatley irritating and based on read-across method, this result is also relevant for Triethyl borate.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: US Reg. (21 CFR 191.11)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Specific details on test material used for the study:
- - Name of test material: Boric acid
- Molecular formula: H3BO3
- Molecular weight: 61.8
- Smiles notation: B(OH)3
- Substance type: Inorganic
- Physical state: Solid
- Analytical purity: > 99.9 % w/w
- Stability under test conditions: Stable
- Other: White and odourless. - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: Six rabbits with intact and 6 rabbits with abraded skin. 5 mL of boric acid was applied as a 10 % solution on a cellulose pad.
- Concentration: 10 % solution - Duration of treatment / exposure:
- No data
- Observation period:
- No data
- Number of animals:
- 12
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- other: No data
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- other: No data
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 1.7
- Max. score:
- 8
- Reversibility:
- other: No data
- Remarks on result:
- other: Intact plus abraded skin
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not a guideline study and publication does not report whether study performed according to GLP. However, data appears well documented and scientifically acceptable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human (up to) 4-hour covered patch-tests used to determine skin irritation potential of ethanol. Reaction to 20% SDS used as a comparative positive control.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Not further described
- Species:
- other: human
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml - Duration of treatment / exposure:
- Separate patches were applied progressively from 15 minutes, through 30 minutes, 1, 2, 3 and 4 hours. Each application was at a new skin site on the upper arm.
- Observation period:
- Treatment sites assessed at 24, 48 and 72 hours after patch removal.
- Number of animals:
- 31 volunteers
- Irritation parameter:
- other: semi-quantitative response as described above.
- Basis:
- other: number of positive responses from total number tested.
- Time point:
- other: 4h
- Reversibility:
- other: no data
- Remarks on result:
- other: One volunteer presumably had a response determined to be + or greater, but no further details were given.
- Other effects:
- One of 31 volunteers had a positive reaction to ethanol compared to 15/31 of the SDS positive controls.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethanol is not classifiable as to skin irritation. The results indicate that ethanol has only a very low potential to irritate the skin of humans.
- Executive summary:
Up to 4 -hour covered skin patch tests were conducted in 31 volunteers using 0.2 ml neat ethanol. A reaction determined to be indicative of irritation (+ or greater, on a scale of 0, +, ++, or +++) was seen in just one individual. 15 of the 31 volunteers reacted to similar patches with 20% sodium dodecyl sulfate (SDS). The results indicate that ethanol has, at most, just a very low potential to irritate the skin of humans.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary skin irritation study conducted using three male and three female rabbits. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Trimethyl borate- Physical state: liquid
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Langshaw farms, Augusta, Michigan- Housing: Individually housed in hanging wire-mesh cage - Diet (e.g. ad libitum): Purina Certified Rabbit Chow- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 67-82- Humidity (%): 37- Photoperiod (hrs dark / hrs light):12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact skin and Abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5ml/test site
- Duration of treatment / exposure:
- 24 h
- Observation period:
72 h- Number of animals:
- 6 rabbits (3 male and 3 female)
- Details on study design:
- TEST SITE- Area of exposure: Back of each rabbit- Coverage: 20-30 % of the body surface- Type of wrap if used: Guaze bandaging and Saran Wrap and over wrapped with several layers of 75 millimeter Elastoplast Tape. A collar was also applied to each animal.REMOVAL OF TEST SUBSTANCE- Washing (if done): 24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels.- Time after start of exposure: Each test site was observed for skin irritation at 24 and 72 hours after test article application.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritant / corrosive response data:
- Calculations for Primary Skin Irritation Score: 3.0/12 + 2.5/12=0.5 (Score: The average of all the erythema scores plus the average of all the edema scores)
- Other effects:
- Mortality:None of the rabbits died during the 3-day study period.Pharmacotoxic signs:All of the animals appeared normal the 3-day study period, except for one male animal of the Intact group, which had diarrhea at 24 and 48 hours.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based upon the data obtained, the article TS2-16B Trimethyl borate, would not be considered a primary skin irritant.
- Executive summary:
3 male and 3 female young adult New Zealand white rabbits were subjected to skin irritation test to evaluate the test substance, Trimethyl borate. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group.
24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels and observed for the next 72 hours for the following:
Primary Skin Irritation:
Each test site was observed for skin irritation at 24 and 72 hours after test article application.
Mortality:
The rabbits were observed twice daily (AM & PM) for mortality for a total of 3 days.
Pharmacotoxic signs:
The rabbits were observed for pharmacotoxic signs at 24 hours and once daily thereafter for a total of 3 days.
Body weights:
Body weights were obtained at study initiation (control) and study termination.
Based upon the data obtained (Primary Irritation Score = 0.5), the article TS2-16B Trimethyl borate, would not be considered a primary skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Referencing ECHA's Read-Across Assessment Framework (RAAF) as basis, an analogue approach is used to assess the read-across potential for the target substance triethyl borate (CAS 150-46-9 , EC 205-760-9) from the source substance trimethyl borate (CAS 121-43-7, EC 204-468-9).
This read-across is based on the hypothesis that source and target substances are structurally similar substances, which have similar toxicological properties because they rapidly hydrolyse to a common product: Boric acid (Boric acid is a very weak acid, with a p Ka of 9.15), and to non-common compounds which does not influence the prediction of the property under consideration (based on worst-case approach) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary skin irritation study conducted using three male and three female rabbits. From this group of randomly selected animals, three rabbits were assigned to an intact group and three rabbits were assigned to an abraded group
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Trimethyl borate- Physical state: liquid
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Langshaw farms, Augusta, Michigan- Housing: Individually housed in hanging wire-mesh cage - Diet (e.g. ad libitum): Purina Certified Rabbit Chow- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 67-82- Humidity (%): 37- Photoperiod (hrs dark / hrs light):12/12
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Intact skin and Abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5ml/test site
- Duration of treatment / exposure:
- 24 h
- Observation period:
72 h- Number of animals:
- 6 rabbits (3 male and 3 female)
- Details on study design:
- TEST SITE- Area of exposure: Back of each rabbit- Coverage: 20-30 % of the body surface- Type of wrap if used: Guaze bandaging and Saran Wrap and over wrapped with several layers of 75 millimeter Elastoplast Tape. A collar was also applied to each animal.REMOVAL OF TEST SUBSTANCE- Washing (if done): 24 hours following test application, the bandages and collars were removed and the test sites were wiped clean with dry, disposable paper towels.- Time after start of exposure: Each test site was observed for skin irritation at 24 and 72 hours after test article application.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Animal No. 5059, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Animal No. 5065, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Animal No. 5062, Female
- Time point:
- 72 h
- Score:
- 0.5
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Animal No. 5063, Male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Animal No. 5058, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 1
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 24 h
- Score:
- 0.5
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Animal No. 5064, Female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Remarks:
- No 48h data
- Irritant / corrosive response data:
- Calculations for Primary Skin Irritation Score: 3.0/12 + 2.5/12=0.5 (Score: The average of all the erythema scores plus the average of all the edema scores)
- Other effects:
- Mortality:None of the rabbits died during the 3-day study period.Pharmacotoxic signs:All of the animals appeared normal the 3-day study period, except for one male animal of the Intact group, which had diarrhea at 24 and 48 hours.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based upon the data obtained, the article TS2-16B Trimethyl borate would not be considered a primary skin irritant and this result is also relevant for Triethyl borate based on the supplied read-across justification.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study with only basic documentation but carried out to guideline and contains enough detail to be able to judge the results reliable as a supporting study. Individual animal results not available.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Analytical purity: Test substance was neat ethanol.
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 100 other: microlitre into lower conjunctival sac. - Duration of treatment / exposure:
- single instillation of 0.1ml
- Observation period (in vivo):
- 72 hours only reported
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize method of scoring used.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 0.28
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 2.4
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not specified
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Classification: irritating
- Executive summary:
In a guideline eye irritation study results in rabbits for which only basic but key details are reported, ethanol was found to cause eye irritation. The response was not sufficiently severe to trigger classification under the criteria of directive 67/548 but, based on the available information, appears to be sufficient with respect to the corneal and conjunctival effects to trigger classification as an eye irritant (category 2) under the EU GHS regulation. The study did not include sufficient observations to be able to judge reversibility.- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name of test material (as cited in study report): TS2-16A Trimethyl Borate- Physical state: Liquid- Analytical purity: 99.2%
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Langshaw Farms of Augusta, Michigan- Weight at study initiation: 2220 to 3115 grams- Housing: Individually housed in hanging wire-mesh cage- Identification: Ear tag- Diet: Purina Certified Rabbit Chow, ad libitum- Water: Ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 64-82- Humidity (%): 35-68%- Photoperiod (12 hrs dark / 12 hrs light)IN-LIFE DATES: From: November 8, 1979 To: December 13, 1979
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml, undiluted
- Duration of treatment / exposure:
- Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.
- Observation period (in vivo):
- Observation period: 35 daysThe unwashed group was terminated from the study on day 19
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 14
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No.5037, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 72 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal 5047, Male
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal 5047, Male
- Time point:
- 72 h
- Score:
- 12
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 72 h
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal 5044, Female
- Time point:
- 24 h
- Score:
- 16
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044,, Female
- Time point:
- 72 h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 19
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 11
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 11
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 25
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 25
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 20
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal no. 5053, Male
- Time point:
- 48 h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 48 h
- Score:
- 19
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 7
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- No data
- Irritant / corrosive response data:
- 0.1 ml/right eye, unwashed - Primary eye irritant0.1 ml/right eye, washed - Primary eye irritantCLASSIFICATION0.1 ml/right eye, unwashed -Moderately irritating 0.1 ml/right eye, washed - Moderately irritating
- Other effects:
- None
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated informationCriteria used for interpretation of results: expert judgment
- Conclusions:
- Test material was evaluated as primary eye irritant and classified as moderatley irritating.
- Executive summary:
Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second.
Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.
The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights. The observation period was of 35 days. The unwashed group was terminated from the study on day 19.
Based on the results, test material was evaluated as primary eye irritant and classified as moderately irritating.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note
- Justification for type of information:
- Referencing ECHA's Read-Across Assessment Framework (RAAF) as basis, an analogue approach is used to assess the read-across potential for the target substance triethyl borate (CAS 150-46-9 , EC 205-760-9) from the source substance trimethyl borate (CAS 121-43-7, EC 204-468-9).
This read-across is based on the hypothesis that source and target substances are structurally similar substances, which have similar toxicological properties because they rapidly hydrolyse to a common product: Boric acid (Boric acid is a very weak acid, with a p Ka of 9.15), and to non-common compounds which does not influence the prediction of the property under consideration (based on worst-case approach) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name of test material (as cited in study report): TS2-16A Trimethyl Borate- Physical state: Liquid- Analytical purity: 99.2%
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Langshaw Farms of Augusta, Michigan- Weight at study initiation: 2220 to 3115 grams- Housing: Individually housed in hanging wire-mesh cage- Identification: Ear tag- Diet: Purina Certified Rabbit Chow, ad libitum- Water: Ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 64-82- Humidity (%): 35-68%- Photoperiod (12 hrs dark / 12 hrs light)IN-LIFE DATES: From: November 8, 1979 To: December 13, 1979
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml, undiluted
- Duration of treatment / exposure:
- Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.
- Observation period (in vivo):
- Observation period: 35 daysThe unwashed group was terminated from the study on day 19
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 24 h
- Score:
- 14
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 48 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No. 5037, Male
- Time point:
- 72 h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #1
- Remarks:
- Animal No.5037, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 72 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal 5047, Male
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- 48 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal 5047, Male
- Time point:
- 72 h
- Score:
- 12
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #2
- Remarks:
- Animal No. 5047, Male
- Time point:
- other: 96h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 48 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- 72 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #3
- Remarks:
- Animal No. 5055, Male
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 72 h
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal 5044, Female
- Time point:
- 24 h
- Score:
- 16
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- 48 h
- Score:
- 10
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044,, Female
- Time point:
- 72 h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #4
- Remarks:
- Animal No. 5044, Female
- Time point:
- other: 96h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 48 h
- Score:
- 19
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- 72 h
- Score:
- 11
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #5
- Remarks:
- Animal No. 5046, Female
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 11.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 48 h
- Score:
- 11
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- 72 h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed
- Basis:
- animal #6
- Remarks:
- Animal No. 5052, Female
- Time point:
- other: 96h
- Score:
- 9
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 25
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 25
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 20
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 24 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 48 h
- Score:
- 18
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- 72 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #7
- Remarks:
- Animal No. 5051, Male
- Time point:
- other: 96h
- Score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 20
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal no. 5053, Male
- Time point:
- 48 h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 31.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 24 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 48 h
- Score:
- 19
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- 72 h
- Score:
- 18
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #8
- Remarks:
- Animal No. 5053, Male
- Time point:
- other: 96h
- Score:
- 15
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 7.5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 24 h
- Score:
- 17
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 48 h
- Score:
- 13
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- 72 h
- Score:
- 7
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed
- Basis:
- animal: #9
- Remarks:
- Animal No. 5054, Female
- Time point:
- other: 96h
- Score:
- 5
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- No data
- Irritant / corrosive response data:
- 0.1 ml/right eye, unwashed - Primary eye irritant0.1 ml/right eye, washed - Primary eye irritantCLASSIFICATION0.1 ml/right eye, unwashed -Moderately irritating 0.1 ml/right eye, washed - Moderately irritating
- Other effects:
- None
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated informationCriteria used for interpretation of results: expert judgment
- Conclusions:
- Trimethyl borate was evaluated as primary eye irritant and classified as moderatley irritating and based on the supplied read-across justification, this result is also relevant for Triethyl borate.
Referenceopen allclose all
It is not possible to make a definitive judgement regarding classification as results from individual animals are not available. However, based on the average results across all animals, the occular lesions are not severe enough to warrant classification as an eye irritant under under directive 67/548. However, the criteria for classification under GHS are more stringent and 'significant lesions' are seen under these criteria for corneal opacity ( likely that at least 2 animals >1 based on an average of 1.2) and conjunctival redness (likely that at least 2 animals >2 based on an average of 2.4), hence a judgement that the results from this study support classification as an eye irritant (category 2) based on the immediate effects seen. There is no data on recovery rates.
None
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Referencing ECHA's Read-Across Assessment Framework(RAAF) as basis
the source substance Trimethyl borate (CAS121 -43 -7, EC204 -468 -9) and the target substance Triethyl borate(CAS150 -46 -9, EC205 -760 -9) are structurally similar substances, which rapidly hydrolize to a common product (Boric acid), and to non-common compounds which does not influence the prediction of the properties under consideration (based on worst-case approach), and therefore they will exhibit similar toxicokinetic behaviour.
Trimethyl borate was evaluated as primary eye irritant and classified as moderatley irritating and based on read-across method, and this result is also relevant for Triethyl borate.
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