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EC number: 204-468-9 | CAS number: 121-43-7
- 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
The ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin.
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:
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- 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 days
ENVIRONMENTAL 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:
- mean
- Time point:
- other: 72 Hours
- Score:
- 0.5
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.5
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Remarks on result:
- other: Abraded Skin
- 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:
- not irritating
- Remarks:
- Migrated information Criteria 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.
Reference
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:
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline followed
- 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
- 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 days
ENVIRONMENTAL 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 days
The 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 - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 6.7 - <= 17.1
- Max. score:
- 17.1
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed - Female
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 12.1 - <= 15.4
- Max. score:
- 15.4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- Unwashed - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 4.2 - <= 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- Unwashed - Female
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 1.7 - <= 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 12 - <= 14.7
- Max. score:
- 14.7
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed - Female
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 9.3 - <= 16.7
- Max. score:
- 16.7
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 20 - <= 28.2
- Max. score:
- 28.3
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed - Female
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 5 - <= 7.5
- Max. score:
- 7.5
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- Washed - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Remarks:
- Washed - Female
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 2.5 - <= 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed - Male
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 15.5 - <= 18.5
- Max. score:
- 18.5
- Reversibility:
- not fully reversible within: 34 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed - Female
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- >= 7 - <= 17
- Max. score:
- 17
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- 0.1 ml/right eye, unwashed - Primary eye irritant
0.1 ml/right eye, washed - Primary eye irritant
CLASSIFICATION
0.1 ml/right eye, unwashed -Moderately irritating
0.1 ml/right eye, washed - Moderately irritating - Other effects:
- None
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria 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.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Of the existing studies, the ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin. If current classification criteria are applied to the existing irritation scores for these trimethyl borate samples the classifications are unchanged.
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.
Primary skin irritation on rabbits was recorded in a 10-grade ordinal series and was based upon the severest reaction that developed on the clipped skin of each of five albino rabbits within 24 hours of the uncovered application. Irritation on uncovered rabbit belly was scored to Grade 1 indiactive of no irritation.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
The ocular irritation and skin irritation study on the purified form of trimethyl borate is somewhat old dated, but serves to classify trimethyl borate as moderately irritating to eyes and non-irritating to skin.
Additional studies to characterize the ocular and dermal irritation potential of trimethyl borate seem unnecessary; the data are sufficient for proper regulatory classification.
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