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Registration Dossier
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EC number: 214-049-2 | CAS number: 1074-95-9
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 secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Final Report on the Acute Eye Irritation of 4-tert-butylcyclohexanone in Rabbits
- Author:
- Saltigo GmbH
- Year:
- 1 982
- Bibliographic source:
- 4-tert-butylcyclohexanone, Saltigo GmbH, 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The ocular irritation potential of 4-tert-butylcyclohexanone was evaluated according to OECD Guideline 405 (Acute Eye Irritation / Corrosion
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-tert-butylcyclohexanone
- EC Number:
- 202-678-5
- EC Name:
- 4-tert-butylcyclohexanone
- Cas Number:
- 98-53-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-tert-butylcyclohexanone
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:4-tert-butylcyclohexanone
Molecular Formula: C10H18O
Molecular Weigth: 154.251 g/mol
Physical State: Solid
InChI:1S/C10H18O/c1-10(2,3)8-4-6-9(11)7-5-8/h8H,4-7H2,1-3H3
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical:4-tert-butylcyclohexanone
Molecular Formula: C10H18O
Molecular Weigth: 154.251 g/mol
Physical State: Solid
InChI:1S/C10H18O/c1-10(2,3)8-4-6-9(11)7-5-8/h8H,4-7H2,1-3H3r
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- Reading time: 2 h, and 1, 2, 3, 4, and 7 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6 (male rabbits)
- Details on study design:
- no data available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In all experimental animals showed a marked redness and swelling of the conjunctiva excepted for 1 animal that showed a very strong redness (grade3) were observed.3 animals presented mild hyperemia of the iris. In 5 animals after instillation of drop per fluorescein (2%) has been an erosion of the cornea.All the findings were reversible within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The ocular irritation potential of 4-tert-butylcyclohexanone was evaluated according to OECD Guideline 405 Acute Eye Irritation / Corrosion.
The mean irritation scores over 24, 48 and 72 hours were as follows: cornea = 0.8/10; iris =0.1/2; conjunctivae = 1.2/3; chemosis = 0.4/4. All the effects observed were fully reversible within 7 days.
Based on the scores, 4-tert-butylcyclohexanone can be considered to be not irritating to New Zealand White rabbit eyes. - Executive summary:
The ocular irritation potential of 4-tert-butylcyclohexanone was evaluated according to OECD Guideline 405 Acute Eye Irritation / Corrosion. 6 male New Zealand White rabbits were used for the study.
100 mg of test chemical was instilled into the eyes of rabbits and the effects were observed till 7 days. The untreated eyes served as control. The ocular observations were noted and scored at 2 h, and 1, 2, 3, 4, and 7 days. In all experimental animals showed a marked redness and swelling of the conjunctiva excepted for 1 animal that showed a very strong redness (grade3) were observed. 3 animals presented mild hyperemia of the iris. In 5 animals after instillation of drop per fluorescein (2%) has been an erosion of the cornea.
The mean irritation scores over 24, 48 and 72 hours were as follows: cornea = 0.8/10; iris =0.1/2; conjunctivae = 1.2/3; chemosis = 0.4/4. All the effects observed were fully reversible within 7 days.
Based on the scores, 4-tert-butylcyclohexanone can be considered to be not irritating to New Zealand White rabbit eyes.
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