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Toxicological information

Eye irritation

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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:
1982
Bibliographic source:
4-tert-butylcyclohexanone, Saltigo GmbH, 1982

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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.