Isopentyl p-methoxycinnamate

Acute Toxicity: dermal

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

Isopentyl p-methoxycinnamate

EC Number:

275-702-5

EC Name:

Isopentyl p-methoxycinnamate

Cas Number:

71617-10-2

Molecular formula:

C15H20O3

IUPAC Name:

isopentyl p-methoxycinnamate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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:

other: 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 no

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.