Registration Dossier
Registration Dossier
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EC number: 202-969-7 | CAS number: 101-72-4
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:
- other: limited but acceptable documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Principles of method if other than guideline:
- Method: other: in vivo acute eye irritation study with rabbits
- GLP compliance:
- no
Test material
- Reference substance name:
- N-isopropyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 202-969-7
- EC Name:
- N-isopropyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 101-72-4
- Molecular formula:
- C15H18N2
- IUPAC Name:
- N1-phenyl-N4-(propan-2-yl)benzene-1,4-diamine
- Details on test material:
- Santoflex IP
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: slight erythema and discharge
Any other information on results incl. tables
AVERAGE SCORE: 1.3/110
according to F.H.S.A.: not classed as an eye irritant
immediate: slight discomfort
10 min: slight erythema and discharge
1 h: slight erythema and discharge
24 h: slight erythema and discharge (24 h mean score: 4.0)
48 h: All scored zero
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
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