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EC number: 219-260-3 | CAS number: 2397-00-4
- 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
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- 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
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- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Not skin irritating
Nor eye 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:
- January from 10th to 13th, 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact skin
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4-hour
- Observation period:
- 72 hours
- Number of animals:
- Three rabbits
- Details on study design:
- OBSERVATION TIME POINTS
Skin reactions were recorded 1, 24, 48 and 72 hours after administration. - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Primary Initation Index: 0
Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin respotrses. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not skin irritating
- Executive summary:
A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD guideline 404 and method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A single, 4-hour semi-occluded application (500 mg) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
No erythema or oedema was noted, thus scores of skin reactions in all animals were 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin responses.
Conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item is not a skin irritant.
Reference
Individual skin reactions following 4 -hour exposure period
Animal no. | Reaction | Observation at | Mean 24/48/72 hrs | |||
1 hr | 24 hrs | 48 hrs | 72 hrs | |||
41 Male | Erythema | 0 | 0 | 0 | 0 | 0 |
Oecdma | 0 | 0 | 0 | 0 | 0 | |
40 Male | Erythema | 0 | 0 | 0 | 0 | 0 |
Oecdma | 0 | 0 | 0 | 0 | 0 | |
43 Male | Erythema | 0 | 0 | 0 | 0 | 0 |
Oecdma | 0 | 0 | 0 | 0 | 0 |
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:
- January from 18th to 25th, 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- New Zealand White
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three rabbits
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- Maximum Group Mean Score was 4.1
Classification: mild irritant (class 4 on a 1-8 SCALE).
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 93/21/EEC. No symbol and risk phrase are required. - Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not eye irritating.
- Executive summary:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD guideline 405 and method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single application of 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were observed at 1, 24, 48 and 72 hours after administration.
The Maximum Group Mean Score was 4.1 and the related classification was as mild irritant (class 4 on a 1 -8 SCALE).
Where present, reactions were slight and fully reversible within 72 hours.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the three tested animals.
Therefore, the substance is not an eye irritant.
Reference
lndividual scores for ocular irritation
Animal no. | Reaction | Observation at | Mean 24/48/72 hrs | |||
1 hr | 24 hrs | 48 hrs | 72 hrs | |||
146 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 | |
151 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 1 | 1 | 1 | 0 | 0.67 | |
Conjunctival chemosis | 1 | 1 | 1 | 0 | 0.33 | |
153 male | Corneal opacity | 0 | 0 | 0 | 0 | 0.00 |
Iris | 0 | 0 | 0 | 0 | 0.00 | |
Conjunctival redness | 1 | 0 | 0 | 0 | 0.00 | |
Conjunctival chemosis | 0 | 0 | 0 | 0 | 0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD guideline 404 and EU method B4. A single, 4 -hour semi-occluded application (500 mg) of the test material was administered to the intact skin of three rabbits. Observations of skin reactions were done at 1, 24, 48 and 72 hours after administration. Animals were assessed for erythema and oedema and scores were all 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin responses.
EYE IRRITATION
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD guideline 405 and the method B.5. A single application of 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Observations of ocular reactions were done at 1, 24, 48 and 72 hours after administration. All effects were slight and fully reversible within 72 hours.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).
According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye upon application of a test substance, which is not fully reversible after 21 days from application.
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the three tested animals. All the reactions resulted to be fully reversible withing 72 hours. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).
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