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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 - 22 January 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (analytical purity not reported, no experimental h reading performed)

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
yes no analytical purity reported; no experimental 48 h reading performed
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:
solid
- Name of test material (as cited in study report): p-tert-Butylcyclohexanon
- Physical state: white solid
- Analytical purity: not reported
- Storage condition of test material: in the dark, room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Vehicle:
physiological saline
Controls:
other: not required, untreated sites of the same animal served as control
Duration of treatment / exposure:
24 h
Observation period:
3 days
Reading time points: 1, 24, and 72 h
Number of animals:
6 (males)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animal
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: No 48 h data are available; for the calculation of the mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: No 48 h data are available; for the calculation of the mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Other effects:
Irritant/corrosive response data
At the 24 hour examination very slight erythema (grade 1) and very slight oedema (grade 1) were observed at both the abraded and unabraded sites of 3/6 animals. The skins of remaining animals appeared normal.
At the 72 hour examination there was no evidence of skin irritation in any animal.

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 skin irritation of rabbits due to a 500 mg application of p-tert.-butylcyclohexanon on abraded or unabraded skin and was conducted comparable to OECD Guideline 404. The results showed that 4-tert-butylcyclohexanon is mildly skin irritant.