Registration Dossier
Registration Dossier
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EC number: 210-441-2 | CAS number: 615-66-7
Eye irritation
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:
- 1 992
- 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:
- 2 013
- 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 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
- Reference substance name:
- 1,4-diamino-2-chlorobenzene
- IUPAC Name:
- 1,4-diamino-2-chlorobenzene
- 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 %
Constituent 1
Constituent 2
- 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.
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