Registration Dossier
Registration Dossier
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EC number: 221-897-7 | CAS number: 3271-76-9
Endpoint summary
Administrative data
Description of key information
No skin or eye irritating effects were observed
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:
- 1977/78
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38 No 187 § 1500.41, S. 27019 dated 27.09.73. Evaluation accordig to Draize, J.H. (1959): Dermal Toxicity. In: FDA-Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- other: on part shaved, on part shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24, 72 hours, 8 days
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM:
Erythema and Edema
1 - questionable, very mild
2 - mild
3 - severe
4 - most intensive - Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- at 24 h, and in some animals at 72 h, erythema evaluation was not possible due to staining of the skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No indication of skin irritation was seen in intact and scarified rabit skin.
Reference
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:
- 1977/78
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38 No 187 § 1500.42, S. 27019 dated 27.09.73. Evaluation accordig to Draize, J.H. (1959): Dermal Toxicity. In: FDA-Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics
- Principles of method if other than guideline:
- BASF internal testing method
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
cornea opacity and chemosis
1 - questionable, very mild
2 - mild
3 - severe
4 - most intensive
iris
1 - ciliary injection
2 - iritis
redness
1 - mild
2 - obvious
3 - severe - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.39
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No indication of eye irritation was observed in rabbit eyes
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin and eye irritating properties of Vat Green 3 have been tested in 6 rabbits each according to Federal Register 38 No 187 § 1500.41 and
§ 1500.42, S. 27019 dated 27.09.73, respectively. No skin or eye irritating effects have been noted in these studies.
In addition, no irritating effects on the respiratory tract has been observed during the acute inhalation study in rats.
Justification for classification or non-classification
No irritating effects were observed
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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