Registration Dossier
Registration Dossier
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EC number: 261-675-7 | CAS number: 59231-37-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 May 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isotridecyl 3,5,5-trimethylhexanoate
- EC Number:
- 261-675-7
- EC Name:
- Isotridecyl 3,5,5-trimethylhexanoate
- Cas Number:
- 59231-37-7
- Molecular formula:
- C22H44O2
- IUPAC Name:
- isotridecyl 3,5,5-trimethylhexanoate
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1mL to one eye
- Duration of treatment / exposure:
- Eyes remained unwashed for 24 hours
- Observation period (in vivo):
- 24, 48, 72 hours, 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- All eyes remained unwashed for 24 hours. Observation of corneal opacity, iritis and conjunctivitis were recorded
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Mild (mostly 1 out of 5) conjunctiva were seen in most (5 out of 6) animals at 24 hours only, this has dissapeared at subsequent time points. No adverse observations were recorded with the cornea or iris at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material failed to induce sufficient eye irritation to be considered irritating to skin.
- Executive summary:
In this guideline (CFR 1500.42) study, 0.1mL of the test item (no vehicle) was applied to one eye of 6 rabbits and remained unwashed for 24 hours.
Mild (mostly 1 out of 5) conjunctiva were seen in most (5 out of 6) animals at 24 hours only, this has dissapeared at subsequent time points. No adverse observations were recorded with the cornea or iris at any time point.
The test material failed to induce sufficient eye irritation to be considered irritating to skin.
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