Allyl 3-cyclohexylpropionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Pre-GLP, pre-guideline study, which is to a great extent according to principles similar to those described in OECD TG 401

Data source

Reference

Reference Type:

publication

Title:

Food flavorings and compounds of related structure. I. Acute oral toxicity

Author:

Jenner PM, Hagan EC, Taylor JM, Cook EL, Fitzhugh OG

Year:

1964

Bibliographic source:

Food and Cosmetics Toxicology 2(3), 327-343

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Groups of 10 young adult rats evenly divided by sex were fasted for approximately 18 h prior to treatment. Animals had access to water ad libitum, and the food was replaced in cages as soon as animals received their respective doses. All doses were given by intubation. The usual observation period was 2 weeks. LD50 were computed by the method of Litchfield & Wilcoxon (1949).

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

prop-2-en-1-yl 3-cyclohexylpropanoate

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 18 h
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

no data

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: close observation until animals appeared normal and showed weight gain.
- Other examinations performed: clinical signs

Statistics:

LD50 was computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

585 mg/kg bw

Based on:

test mat.

95% CL:

480 - 714

Mortality:

the death was recorded starting at 4 h and on day 6 post-dose

Clinical signs:

other: other: Depression, rough fur

Gross pathology:

no data

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The substance was acutely toxic to rats in an acute oral toxicity test with a LD50 value of 585 mg/kg bw. The substance is classified into Acute Toxicity Category IV according to CLP.

Executive summary:

The acute oral (gavage) toxicity of the allyl 3-cyclohexylpropionate was studied in a non-GLP test in male and female Osborne-Mendel rats according to principles generally similar to those of OECD TG 401. 5 animals per sex per dose were exposed to single oral (gavage) doses (dose levels were not reported). Animals were observed during a period of 14 days. Time of death was recorded between 4 h and 6 days post-dose. The LD50 value was 585 mg/kg/day with a 95% confidence interval of 480 and 714 mg/kg/bw. Depression and rough fur were observed as toxic signs.