Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February to June 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
The animals belonged to the Sprague Dawley (Him:OFA) strain and were SPF
Supplier: Forschungsinstitut für Versuchstierzucht, A-2325 Himberg, Austria
Number: 20 males and 20 females
Age at the beginning of the study: 8 to 12 weeks.
Hygiene: improved open hygienic conditions.
Room temperature : average of 23 °C
Relative humidity: average of 55 %
Light: artificial light from 7 a.m. to 7 p.m.
Cages: single caging in Makrolon cages type II
Food: Altromin 1314 ff, 10kGy gamma-irradiated, ad libitum
Water : tap water, acidified with HCl to pH 5, ad libitum
Acclimatisation period: 5 d

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was applied once to the dorsal skin of the rats.
Duration of exposure:
The duration of the exposure was 24 h.
Doses:
The test substance was applied once to the dorsal skin of the rats in doses of 2500, 5000, 10000, and 20000 mg per kg body weight (bw).
No. of animals per sex per dose:
Isopentyl p-methoxycinnamatewas administered to 4 groups of 5 male and 5 female rats each.
Control animals:
not specified
Details on study design:
Sacrifice: 14 d after administration of the test substance.
Statistics:
A one-way analysis of variance (p=0.05) was used to evaluate differences in body weights.

Results and discussion

Preliminary study:
No preliminary study was conducted.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
No animal died spontaneously during the experiment.
Clinical signs:
Animal No. 32 lost the linen dressing and the patch 8 h after the administration. In all animals, chromodakryorrhoea was found within the first 24 h after administration. This unspecific change was caused by the reduced wellbeing by the dressing and is not assumed to be a test substance-related effect.
Body weight:
There was no statistically significant difference of body weight between the groups. The body weight gain was slightly lesser n the first week than in comparable untreated rats. Body weight gain was inconspicuous in the second week p.a. This slight reduction in body weight gain, mainly in the females, is regarded to be a test substance related effect.
Gross pathology:
Pathological changes were detected only in 2 animals. Both animals showed hydrometra, a known spontaneous change of this strain of rats, caused by a pronounced intensity of oestrus cycle. These changes are not assumed to have been caused by the test substance.
Other findings:
not applicable

Any other information on results incl. tables

not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test substance caused no alterations or toxic signs in the animals, except a slightly reduction of body weight gain in the first week.
The LD50 (dermal, 14d) was determined to be greater than 20,000 mg/kg bw. Thus, isopentyl p-methoxycinnamate was shown to possess a low degree of toxicity when administered at single dermal doses to male and female rats.
Executive summary:

The acute toxicity of isopentyl p-methoxycinnamate after dermal application to rats was studied.

Isopentyl p-methoxycinnamate was administered to 4 groups of 5 male and 5 female Sprague-Dawley rats each. The test substance was applied once to the dorsal skin of the rats in doses of 2,500, 5,000, 10,000, and 20,000 mg/kg bw.

Methods and investigations performed were in conformance with OECD guideline no. 402, "Acute Dermal Toxicity".

The test substance did not cause any alterations or toxic signs in the animals, except of a slight reduction of body weight gain in the first week. No test substance-related morphological lesions were observed at necropsy.

The LD50(dermal, 14 d) was determined to be greater than 20,000 mg/kg bw. Thus, isopentyl p-methoxycinnamate was shown to possess a low degree of toxicity when administered at single dermal doses to male and female rats.