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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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-butylcyclohexan-1-one
Details on test material:
- Name of test material (as cited in study report): p-tert-Butylcyclhexanon
- Physical state: white solid
- Analytical purity: not reported
- Storage condition of test material: at room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as control
Duration of treatment / exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
7 days
Reading time: 2 h, and 1, 2, 3, 4, and 7 days
Number of animals or in vitro replicates:
6 (males)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Other effects:
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.
In all rabbits no further changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

This study was performed to assess the acute eye irritation by instillation of 4 -tert-butylcyclohexanone into the conjunctivale sac of six rabbits and was conducted comparable to OECD Guideline 405.

The results showed that a single application of 100 mg/animal resulted in moderate eye irritation. Therefore, according to Directive 2001/59/EC 4-tert-Butylcyclohexanon does not meet the criteria for classifcation as an eye irritant.