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EC number: 205-465-5 | CAS number: 141-17-3
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
skin irritation (similar to OECD 404): not irritating
eye irritation (EPA OTS 798.4500): not irritating
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:
- 4 Nov 1997 - 11 Nov 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Age at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 13 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 4 Nov 1997 to 11 Nov 1997
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days Reading time points: 4.5, 24, 48, and 72 h and 7 days after treatment)
- Number of animals:
- 6 (3 males, 3 females)
- Details on study design:
- TEST SITE- Area of exposure: approximately 6 cm²- Type of wrap if used: The area was covered with a 2.5 cm² surgical gauze pad (Johnson & Johnson). This was held in place with 3 inch Johnson & Johnson hypo-allergenic cloth tape, semi-occlusively. Animals were collared for the deration of the exposure to preclude access to the siteREMOVAL OF TEST SUBSTANCE- Washing (if done): Remaining test article was gently washed from the skin with water and paper towels.- Time after start of exposure: 4 hSCORING SYSTEM: Each site was then individually examined and scored at 30 and 60 minutes following unwrapping for erythema and edema according to the Draize Scoring System.OTHERThe hair of the mid-dorsal area of the trunk of each animal, between scapulae and pelvis, was shaved using an Oster small animal clipper with surgical head (#40). Care was taken to avoid abrasion of the skin during clipping. Prior to dose application, animals were placed into wooden restrainers.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: One animal showed accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: revrsibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- The animals did not exhibit any abnormal clinical signs for the duration of the study.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
Reference
Table 1: Primary dermal irritation in rabbits / individual results
Rabbit (number) |
4 ½ hr |
24 hr |
48 hr |
72 hr |
Day 7 |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
- |
- |
2 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
3 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
- |
- |
4 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
5 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0* |
6 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
* Accumulation of loose fragments of horny layer of skin (stratum corneum). Peeling. Only uppermost layer involved.
The primary dermal irritation index was 0.65. The animals in this study did not exhibit any abnormal signs for the duration of the study. Under the conditions of this study, the test article elicited minimal irritation.
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:
- 27 Oct 1997 - 30 Oct 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Ag at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 27 Oct 1997 - 30 Oct 1997
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye remained untreated and served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single administration without washing
- Observation period (in vivo):
- 72 hoursReading time points: 1, 24, 48, and 72 h after treatment
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- SCORING SYSTEM: Draize Scoring SystemTOOL USED TO ASSESS SCORE: fluorescein, hand-held ophthalmoscope
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
Reference
Table 1: Primary ocular irritiation in rabbits - Summary
Rabbit number |
Bodyweight [kg] |
Reading time [h] |
Cornea |
Iris |
Conjunctivae |
|||
Score |
Area |
Redness |
Chemosis |
Discharge |
||||
1 |
Init: 1.96 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.86 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Init: 1.97 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.87 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Init: 1.86 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.76 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Init: 1.99 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.89 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
Init: 1.88 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.79 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
Init: 2.0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.96 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The available key study was conducted similar to the OECD 404 test guideline and in compliance with GLP (Nitka, 1997). Three New Zealand White rabbits received the neat test item at a volume of 0.5 mL on the shaved skin under semiocclusive conditions. After 4 h, the test item was removed by washing of the application sites and the animals were observed and scored for erythema and oedema for up to 7 days. According to the Draize Scoring System the mean erythema score over 24, 48 and 72 h out of all six animals was 0.72, the respective oedema score was 0. The erythema observed was fully reversible within 7 days. One animal showed accumulation of loose fragments of horny layer of skin (stratum corneum), however, only the uppermost layer was involved. The animals in this study did not exhibit any abnormal signs for the duration of the study. In conclusion, the test item was not irritating to the skin under the conditions of the test.
Eye irritation:
The available key study was conducted according to the EPA OTS 798.4500 (Acute Eye Irritation) test guideline and in compliance with GLP (Nitka, 1997). Three New Zealand White rabbits received the neat test item as a single instillation of 0.1 mL into one eye, whereas the other eye remained untreated and served as control. The eyes remained unwashed. The animals were evaluated for ocular effects 24, 48, and 72 h post-exposure using fluorescein staining. Effects noted were graded according to the Draize Scoring System and revealed mean cornea, iris, and chemosis scores over 24, 48 and 72 h out of all six animals of zero. The respective conjunctivae score was 0.22 and the effects observed were fully reversible within 48 h. The animals did not exhibit any abnormal clinical signs for the duration of the study. In conclusion, the test item was not irritating to the eye under the conditions of the test.
Justification for selection of skin irritation / corrosion endpoint:
The key study was selected for assessment.
Justification for selection of eye irritation endpoint:
The key study was selected for assessment.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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