Reaction mass of 1-methyl-4-(1-methylethylidene)cyclohexyl acetate and p-menth-1-en-8-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

publication

Title:

Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity

Author:

Jenner PM, et al.

Year:

1964

Bibliographic source:

Fd Cosmet. Toxicol. Vol. 2, pp. 327-343. Pergamon Press 1964.

Report date:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-menth-1-en-8-yl acetate

EC Number:

201-265-7

EC Name:

p-menth-1-en-8-yl acetate

Cas Number:

80-26-2

Molecular formula:

C12H20O2

IUPAC Name:

1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate

Test material form:

liquid

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: approximately 18
- Housing: Cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

All doses were given by intubation.

Doses:

Not reported

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.

Statistics:

LD50's were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 075 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 160 - <= 6 190

Mortality:

Death Time: 4 hr - 5 days

Clinical signs:

other: Depression, scrawny appearance, porphyrin-like deposits around eyes and nose

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful

Remarks:

in accordance with EU CLP (EC no. 1272/2008 and its updates)

Conclusions:

Terpinyl acetate alpha has an LD50 of 5075 mg/kg bw in an OECD TG 401 test.

Executive summary:

In an acute oral toxicity study groups of 10 Osborn-Mendal rats were exposed through oral intubation to the test substance. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. Animals exposed to terpinyl acetate alpha showed depression, scrawny appearance, and porphyrin-like deposits around eyes and nose. A LD50 of 5075 mg/kg bw (95% CI = 4160-6190) was determined.