Registration Dossier
Registration Dossier
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EC number: 413-810-8 | CAS number: 65181-78-4 OP-262; ST 16-1.1; ST 16-1.2; SUBSTANCE S123104
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to EU B.5 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-diphenyl-N,N'-bis(3-methylphenyl)-(1,1'-diphenyl)-4,4'-diamine
- EC Number:
- 413-810-8
- EC Name:
- N,N'-diphenyl-N,N'-bis(3-methylphenyl)-(1,1'-diphenyl)-4,4'-diamine
- Cas Number:
- 65181-78-4
- Molecular formula:
- C38H32N2
- IUPAC Name:
- N4,N4'-bis(3-methylphenyl)-N4,N4'-diphenyl-[1,1'-biphenyl]-4,4'-diamine
- Details on test material:
- Name of test material: N4,N4'-Diphenyl-N4,N4'-di-m-tolyl-biphenyl-4,4'-diamine
Physical state: white powder
Xerox chemical 17641-2-1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 MG
- Observation period (in vivo):
- 24h, 48h, 72h, 96h, 7 days,10 days, 13 days
- Number of animals or in vitro replicates:
- 20 rabbits 12 of these received a washout 30 s following instillation with 100 ml lukewarm dist. water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- unwashed
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 5.1
- Remarks on result:
- other: untreated control: 0.3 at 72h
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- washed
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1.6
- Remarks on result:
- other: untreated control:0.0 for the duration of the study
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 10 days
- Other effects:
- 100 mg/unwashed eye: slight irritation
100 mg/washed eye: minimal irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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