Registration Dossier
Registration Dossier
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EC number: 247-201-1 | CAS number: 25711-72-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of p-Phenylenediamine, p-Phenylenediamine HCl, and p-Phenylenediamine Sulfate
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 007
- Bibliographic source:
- Cosmetic Ingredient Review, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- To assess the ocular irritation potential of p-phenylenediamine in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-phenylenediamine
- EC Number:
- 203-404-7
- EC Name:
- p-phenylenediamine
- Cas Number:
- 106-50-3
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 1,4-diaminobenzene
- Test material form:
- solid
- Details on test material:
- - Name of test material: p-phenylenediamine
- Molecular formula: C6H8N2
- Molecular weight: 108.1432 g/mol
- Substance type: Organic
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: p-phenylenediamine
- Molecular formula: C6H8N2
- Molecular weight: 108.1432 g/mol
- Substance type: Organic
- Physical State: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- no data available
- Observation period (in vivo):
- no data available
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- no data available
- Details on study design:
- SCORING SYSTEM: Draize method
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Score:
- 17
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The maximum irritation score reported for p-phenylenediamine was 17.0 of a possible 110
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The maximum irritation score reported for p-phenylenediamine was 17.0 of a possible 110. Based on the scores, p-phenylenediamine can be considered mildly irritating to rabbit eyes.
- Executive summary:
The ocular irritation potential of p-phenylenediamine was assessed in rabbits according to Draize method. 100% p-phenylenediamine was instilled into rabbit eyes and observed for signs of irritation (duration not mentioned).The ocular reactions were scored according to Draize method. The maximum irritation score reported for p-phenylenediamine was 17.0 of a possible 110. Based on the scores, p-phenylenediamine can be considered mildly irritating to rabbit eyes.
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