p-menth-1-en-8-ol

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:

comparable to guideline study with acceptable restrictions

Remarks:

Method similar to OECD guideline 423, but no information on doses were reported

Data source

Reference

Reference Type:

publication

Title:

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

Author:

Jenner P M

Year:

1964

Bibliographic source:

Food and Cosmetics Toxicology. Vol. 2, pp. 327-343

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No information on tested doses

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 animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adults rats
- Fasting period before study: 18 h
- Housing: cages
- Diet (e.g. ad libitum): Food was replaced in cages as soon as animals received their doses.
- Water (e.g. ad libitum): Ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Not reported

No. of animals per sex per dose:

5 females and 5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 2 weeks
- Necropsy of survivors performed: no specified
- Other examinations performed: clinical signs, body weight and time of death

Statistics:

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

Results and discussion

Effect levels

Key result

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.

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

The LD50 of the test item is 5075 mg/kg body weight by oral route in the rat.

Executive summary:

The acute oral toxicity of the test compound was tested following a method similar to OECD Test Guideline 401. Ten young adult Osborne-Mendel rats evenly divided by sex were administered by oral gavage.

Animals were observed for 2 weeks during which time the development of toxic signs was followed and time of death recorded. Animals exposed to terpinyl acetate alpha showed depression, scrawny appearance, and porphyrin-like deposits around eyes and nose. The acute oral LD50 of the test item was determined to be 5075 mg/kg bw (95% confidence limits: 4160 -6190 mg/kg bw).