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Toxicological information

Eye irritation

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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:
2007
Bibliographic source:
Cosmetic Ingredient Review, 2007

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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.