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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:
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:
Eye irritation study was conducted on rabbits to evaluate the irritation potential of the test compound 2-chloro-p-phenylenediamine (CAS No.- 615 -66-7).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-chloro-p-phenylenediamine
- Molecular formula (if other than submission substance): C6H7N2Cl
- Molecular weight (if other than submission substance): 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity 99%
- Impurities (identity and concentrations): 1 %
Specific details on test material used for the study:
- Name of test material (as cited in study report):2-chloro-p-phenylenediamine
- Molecular formula:C6-H7-Cl-N2
- Molecular weight:142.588 g/mole
- Substance type:Organic
- Physical state:Solid
- Purity: 99%
- Impurities (identity and concentrations): 1 %

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
water
Remarks:
Water buffered to pH 7 with 0.05% sodium sulfite
Controls:
not specified
Amount / concentration applied:
2.5 % (w/v)
Duration of treatment / exposure:
No data available
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: Eye
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were rinsed with 20 mL of distilled water.
- Time after start of exposure: Ten seconds

SCORING SYSTEM: No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
other: non-irritating
Irritant / corrosive response data:
One animal showed mild conjunctival inflammation. Two animals did not show any observable response to treatment throughout the 7 days observa tion period.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating based on CLP criteria
Conclusions:
The substance 2-chloro-p-phenylenediamine is non-irritating to the eyes of rabbits.
Executive summary:

Eye irritation study was conducted on 3 rabbits to evaluate the irritation potential of the test compound 2-chloro-p-phenylenediamine (CAS No.- 615 -66 -7). 2.5% (w/v) 2-chloro-p-phenylenediamine in water (pH 7) was instilled into one eye of each of the three rabbits. Ten seconds after instillation the eyes were rinsed with 20 mL of distilled water.  

In one animal mild conjunctival inflammation was observed. Two animals did not show any observable response to treatment throughout the 7 days observati on period.  

2-chloro-p-phenylenediamine is non-irritating to the eyes of rabbits and being classified as "not classified" as per CLP regulation.