Registration Dossier
Registration Dossier
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EC number: 225-443-9 | CAS number: 4851-50-7
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone
- EC Number:
- 225-443-9
- EC Name:
- 1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone
- Cas Number:
- 4851-50-7
- Molecular formula:
- C34H34N2O4
- IUPAC Name:
- 1,4-bis[(4-tert-butylphenyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- ca. 50 mg
- Duration of treatment / exposure:
- 7 days (eyes were not washed).
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.
- Executive summary:
Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours. Macrolexgrün G was not irritating in this test.
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