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Registration Dossier
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EC number: 207-395-0 | CAS number: 467-62-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Acute Toxicity, Skin and Eye Irritancy and Skin Sensitization Potential of Ancamine D.
- Author:
- NTRL (National Technical Reports Library)
- Year:
- 1 986
- Bibliographic source:
- NTRL REPORT; OTS0511923; 15/10/1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Federal Register
- Principles of method if other than guideline:
- An eye irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on albino New Zealand White rabbits to determine its eye irritation efficacy.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4,4'-methylenedianiline
- EC Number:
- 202-974-4
- EC Name:
- 4,4'-methylenedianiline
- Cas Number:
- 101-77-9
- Molecular formula:
- C13H14N2
- IUPAC Name:
- 4, 4’- diaminodiphenylmethane
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits Crawley, Suasex
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Amount :10-20mg
concentration applied :100% - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 3 hours after application and again 1, 2, 3 and 7 day after application.
- Number of animals or in vitro replicates:
- 4 (2/sex)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): conjuctivital sac of
- Time after start of exposure: 3 hours
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No eye irritation was observed.
Any other information on results incl. tables
TABLE: 1. Irritation Scores of rabbits’ eyes |
||||||
Rabbit No. |
|
3 hours |
24 hours |
48 hours |
72hours |
7 days |
Male 63 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
|
Female 64 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
|
Male 118 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
|
Female 117 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- The test chemical 4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ eye
- Executive summary:
An eye irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on four (2/sex) albino New Zealand White rabbits to determine its eye irritation efficacy.
In this test, 10-20 mg of undiluted 4,4'-Methylenedianiline was installed into the conjunctival sac of each rabbit . Following instillation, one eye was washed and the other was not. The eyes were observed for 1, 2, 24, 48 and 168 hours.
Since no eye irritation was observed, thechemical4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ eye.
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