Registration Dossier
Registration Dossier
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EC number: 204-616-2 | CAS number: 123-30-8
Endpoint summary
Administrative data
Description of key information
Studies conducted to standards in place at the time of the study for skin and eye irritation were conducted. Studies found slight to no effects on the skin and slight reversible irritation on the eye.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: US Consumer Product Safety Commission (Code of Federal Regulations, Title 16, Section1500.41)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: 0.5% aqueous gum tragacanth, containing 0.05% anhydrous sodium sulphite (Na2SO3)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 2.5%(w/v)suspension - Number of animals:
- 3 rabbits
- Irritation parameter:
- other: primary irritation index
- Score:
- 0.2
- Remarks on result:
- other: mildly irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: data provided as primary index value
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: data provided as primary index value
- Irritant / corrosive response data:
- The treatment led to slight edema of both the intact and abraded site in one rabbit at 24hr after application indicating very mild skin irritancy.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 4-aminophenol was slightly irritant to rabbit skin based on US Consumer Product Safety Commission criteria.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Protocols followed based on OECD and cosmetic irritation protocols; no confirmation of GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- also applied Official French Cosmetic (OFC) method
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g applied under occlusive and semi-occlusive conditions
- Duration of treatment / exposure:
- 4 hours or at 23 hours
- Observation period:
- 48 hours
- Number of animals:
- 6 / group
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: all
- Score:
- >= 0
- Max. score:
- 8
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
4 -aminophenol was not irritating according to CLP classification guidelines for these endpoints.
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