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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication published in a peer reviewed journal with limitations in design and/or reporting but otherwise adequate for assessment.

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

Constituent 1
Chemical structure
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:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Terpinyl Acetate

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

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A LD50 of 5075 mg/kg bw was obtained in the acute oral toxicity study with rats.
Executive summary:

In an acute oral toxicity study, performed similar to OECD Guideline 401, 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.