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Toxicological information

Skin irritation / corrosion

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Administrative data

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final Report on the Safety Assessment of 2-Chloro-p-Phenylenediamine and 2-Chloro-p-Phenylenediamine Sulfate
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1992
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 11, Number 4,1992.
Reference Type:
secondary source
Title:
OPINION ON 2-Chloro-p-phenylenediamine COLIPA n° A8
Author:
European Cosmetics Toiletry and Perfumery Association (COLIPA)
Year:
2013
Bibliographic source:
Scientific Committee on Consumer Safety (SCCS), SCCS/1510/13, 19 September 2013

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The skin irritation study was conducted on albino rabbits to assess the irritation potential of 2-chloro-p-phenylenediamine.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : 2-chloro-p-phenylenediamine
- Molecular formula: C6-H7-Cl-N2
- Molecular weight : 142.588 g/mole
- Smiles: c1(c(ccc(c1)N)N)Cl
- InChI: 1S/C6H7ClN2/c7-5-3-4(8)1-2-6(5)9/h1-3H,8-9H2
- Substance type: Organic
- Physical state: Solid
- Purity: 99%
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-chloro-p-phenylenediamine
- Molecular formula: C6H7N2Cl
- Molecular weight: 142.588 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: 99%
- Impurities (identity and concentrations):1 %

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino
Details on test animals and environmental conditions:
Albino rabbits were used for the study.

Test system

Type of coverage:
other: Patch tests
Preparation of test site:
other: one intact and one abraded site
Vehicle:
water
Remarks:
Distilled water
Controls:
not specified
Amount / concentration applied:
0.5 ml of 2.5% w/v 2-chloro-p-phenylenediamine in distilled water.
Observation period:
24 hours and 72 hours
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: one intact and one abraded site on the dorsum
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: After 24 hours of exposure, the patches were removed and the test sites scored on a scale of 0 to 4 (CFR, Title 16, Section 1500.41). Sites were scored again 72 h after the application.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
no data
Remarks on result:
other: No observable response were observed
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the 72 hours observation period.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating based on CLP criteria
Conclusions:
In a skin irritation test in rabbits with 0.5 ml, 2.5%w/v 2-chloro-p-phenylenediamine in distilled water , no irritation was observed after 24 and 72 hours of observation period.
Thus, the test chemical 2-chloro-p-phenylenediamine can be judged as a non irritant.
Executive summary:

The skin irritation study was conducted on albino rabbits to assess the irritation potential of the test compound 2-chloro-p-phenylenediamine. 3 albino rabbits were clipped free of hair. A patch with 0.5 ml of 2.5% w/v 2-chloro-p-phenylenediamine in distilled water was applied to both one abraded and one intact site on each animal. After 24 hours of exposure, the patches were removed and the test sites scored on a scale of 0 to 4 (CFR, Title 16, Section 1500.41). Sites were scored again 72 h after the application. None of the animals showed any observable response to treatment throughout the 72 hours observation period. Thus, based on the study 2-chloro-p-phenylenediamine (CAS No: 615-66-7) is not considered to be an irritant to rabbit skin and being classified as "not classified" as per CLP regulation.