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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
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

Constituent 1
Chemical structure
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
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.