2-chloro-p-phenylenediamine

Skin irritation / corrosion

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

2-chloro-p-phenylenediamine

EC Number:

210-441-2

EC Name:

2-chloro-p-phenylenediamine

Cas Number:

615-66-7

Molecular formula:

C6H7ClN2

IUPAC Name:

2-chlorobenzene-1,4-diamine

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 or test system 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.