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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
cis-2-tert-butylcyclohexyl acetate
EC Number:
243-718-1
EC Name:
cis-2-tert-butylcyclohexyl acetate
Cas Number:
20298-69-5
Molecular formula:
C12H22O2
IUPAC Name:
2-tert-butylcyclohexyl acetate
Test material form:
liquid
Details on test material:
Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
No data.
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
10/dose; sex unknown
Control animals:
no
Details on study design:
- Necropsy of survivors performed: not clear from report
- Other examinations performed: skin irritation (time/frequency of observations not reported)

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: Diarrhea was observed in 1 animal.
Other findings:
Skin irritation: Slight redness in 6 animals, moderate redness in 4 animals; slight edema in 3 animals, moderate edema in 7 animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful
Remarks:
in accordance with EU CLP (1272/2008 and its updates)
Conclusions:
A LD50 > 5000 mg/kg bw was established in an acute dermal toxicity study with rabbits.
Executive summary:

In an acute dermal toxicity study with rabbits, similar to OECD TG 402 but non-GLP, the LD50 was greater than 5000 mg/kg bw. A group of 10 animals (strain, sex and age unspecified) received a single application of 5000 mg/kg bw test substance. There were no deaths. Diarrhea was observed in one animal. Skin irritation findings included erythema (slight in 6 animals, moderate in 4 animals) and edema (slight in 3 animals, moderate in 7 animals).