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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, slightly deviating from current testing guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Principles of method if other than guideline:
Groups of four animals were exposed topically to one dermal dose of test substance. Animals were observed during a period of 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl 3-cyclohexylpropionate
EC Number:
220-292-5
EC Name:
Allyl 3-cyclohexylpropionate
Cas Number:
2705-87-5
Molecular formula:
C12H20O2
IUPAC Name:
allyl 3-cyclohexylpropanoate
Details on test material:
- Name of test material (as cited in study report): Allyl cyclohexyl propionate
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not reported

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Not reported
Duration of exposure:
Not reported
Doses:
0.313, 1.25 and 5.0 g/kg body weight
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: not reported
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
95% CL:
430 - 2 770
Mortality:
In the low-dose group, no animal died during the observation period of 14 days. In the mid-dose group, one animal died on day one following dermal exposure. In the high-dose group, all animals died within the 14-day observation period; three animals were found dead on day 1 following dermal exposure, one animal died on observation day 4.
Clinical signs:
Ataxia was observed in one animal of the mid-dose group.
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
The skin irritation potential of the substance was observed and moderate redness and oedema were observed in animals of all dose groups.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely toxic to rabbits in an acute dermal toxicity test with an LD50 value of 1600 mg/kg body weight. The substance is classified into Acute Toxicity Category IV according to CLP.
Executive summary:

The acute dermal toxicity of the test substance allyl cyclohexyl propionate was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. Groups of four animals were exposed to single dermal doses of 0.313, 1.25 and 5.0 g/kg body weight. Animals were observed during a period of 14 days. No mortality was observed in the low-dose group, whereas one animal in the mid-dose group and 4 animals in the high-dose group died within the observation period. The LD50 value was 1.6 g/kg bw with a 95% confidence interval of 0.43 to 2.77 g/kg bw. Ataxia was observed in one animal dosed with 1.25 g/kg bw. Slight to moderate skin irritation was observed in animals of all dose groups.