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EC number: 946-937-7 | CAS number: -
- 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
Skin Irritation (in vivo)
Under the conditions of this study, the test material was considered to be non-irritating to the skin.
Eye Irritation (in vivo)
Under the conditions of this study the test material was considered to be non-irritating to eyes.
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:
- 07 August 2009 to 20 October 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemicals Section 4: Health Effects (ministry of environmental protection of People's Republic of China).
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adults
- Acclimation period: 5 days prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24°C
- Humidity: 50 to 70% - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 4 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm^2 area on the scapular to lumbar region of the back.
- Type of wrap if used: The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours, coverings were removed and the application sites were rinsed completely with warm water.
OBSERVATION TIME POINTS
Animals were observed continually for 14 days, Skin irritation was evaluated at approximately 1, 24, 48 and 72 hoursr after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity.
SCORING SYSTEM:
The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Other effects:
- Individual skin irritation scores are presented in Table 1. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined to be non-irritating to the skin.
- Executive summary:
The skin irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). The test material was administered to a 2 x 3 cm2 area on the scapular to lumbar region of the back that had been shaved on the previous day. The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape. After 4 hours, coverings were removed and the application sites were rinsed completely with warm water. Animals were observed continually for 14 days. Skin irritation was evaluated at approximately 1, 24, 48 and 72 hours after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0. Under the conditions of this study, the test material was considered to be non-irritating to the skin.
Reference
Table 1: Skin irritation scores
Animal No. |
Position |
Skin Irritation scores |
|||||||
1 h |
24 h |
48 h |
72 h |
||||||
R |
L |
R |
L |
R |
L |
R |
L |
||
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
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:
- 07 August 2009 to 20 October 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China).
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adults
- Acclimation period: 5 days prior to the test
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24ºC
- Humidity: 50 to 70% - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4 animals
- Details on study design:
- TREATMENT METHOD
- 0.1 g of the test material was applied to the conjunctival sac of right eye of each rabbit. The lids were then gently held together for about one second to prevent loss of the test material. No washing to eyes was taken for 24 hours after application.
OBSERVATIONS
- Eye irritation was evaluated at 1, 24, 48 and 72 hours after test material application. The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. Animals were observed daily for mortality and signs of morbidity. Survival animals were euthanatised after observation period. - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- Max score not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis scores were not measured
- Other effects:
- Individual eye irritation scores are presented in Table 1. No abnormal clinical signs were observed during the whole study period. No delayed damnification was observed for all animals. The highest mean eye irritation score in the first 4 days (mean of sum of the scores from cornea, iris and conjunctivae) was 2.5 and the score was 0 at 48 hours. All controls scored 0. Based on these results and the irritation grading criteria in the Guidelines for the Testing of Chemicals, the test article is light irritating to eye (the grade is 3).
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of this study, based on the Guidelines for the Testing of Chemicals the test material is light irritating to eye (the grade is 3).
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). 0.1 g of test material was administered into the conjunctival sac of right eye of four healthy rabbits with eye lids gently held together for about one second to prevent loss of the test material. The left eye was used as control for evaluation of eye irritation. No washing to eyes was taken for 24 hours after application. Eye irritation was evaluated at 1, 24, 48 and 72 hours after test material application. The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. Animals were observed daily for mortality and signs of morbidity; surviving animals were euthanatised after the observation period. Under the conditions of this study the highest mean eye irritation score in the first 4 days was 2.5 and the score was 0 at 48h. Based on the Guidelines for the Testing of Chemicals, the test material is 'lightly' irritating to the eye (the grade is 3).
Reference
Table 1: Eye irritation scores
Animal No. |
Position |
Eye Irritation scores |
|||||||
1 h |
24 h |
48 h |
72 h |
||||||
R |
L |
R |
L |
R |
L |
R |
L |
||
1 |
Conjunctivae |
2 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Conjunctivae |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Conjunctivae |
4 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Conjunctivae |
2 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total |
10 |
0 |
8 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
2.5 |
0.0 |
2.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Mean score (4 days) |
2.5, 0 (48 h) |
||||||||
Irritation |
Light irritation |
||||||||
Grade |
3 |
R = right eye, L = left eye
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation (in vivo)
The skin irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). The test material was administered to a 2 x 3 cm2 area on the scapular to lumbar region of the back that had been shaved on the previous day. The application sites were covered with two layers of polyethylene sheet, secured with adhesive tape. After 4 hours, coverings were removed and the application sites were rinsed completely with warm water. Animals were observed continually for 14 days. Skin irritation was evaluated at approximately 1, 24, 48 and 72 hours after patches were removed from the sites. Animals were observed daily for mortality and signs of morbidity. No abnormal clinical signs were observed during the whole study period. The mean skin irritation score was 0. Under the conditions of this study, the test material was considered to be non-irritating to the skin.
Eye Irritation (in vivo)
The eye irritation potential of the test material was investigated in accordance with the Guidelines for the Testing of Chemicals Section 4; Health Effects (ministry of environmental protection of People's Republic of China). 0.1 g of test material was administered into the conjunctival sac of right eye of four healthy rabbits with eye lids gently held together for about one second to prevent loss of the test material. The left eye was used as control for evaluation of eye irritation. No washing to eyes was taken for 24 hours after application. Eye irritation was evaluated at 1, 24, 48 and 72 hours after test material application. The degree of irritation was scored according to the procedure of the Guidelines for the Testing of Chemicals. Animals were observed daily for mortality and signs of morbidity; surviving animals were euthanised after the observation period. Under the conditions of this study the highest mean eye irritation score in the first 4 days was 2.5 and the score was 0 at 48 hours. Based on the Guidelines for the Testing of Chemicals, the test material is 'lightly' irritating to the eye (the grade is 3).
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to irritation to skin or eyes.
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