[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1964

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 et al.

Year:

1964

Bibliographic source:

Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity. Fd Cosmet. Toxicol. Vol. 2, pp. 327-343. Pergamon Press 1964. Printed in Great Britain

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

Not all animals were of the same sex, no data on whether animals that died during the test were necropsied.

GLP compliance:

not specified

Remarks:

The study is a publication

Test type:

other: not reported

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate

EC Number:

201-036-1

EC Name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate

Cas Number:

77-54-3

Molecular formula:

C17H28O2

IUPAC Name:

[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Fasting period before study: 18 hrs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

No data

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: two weeks
- Frequency of observations and weighing: close observation, no frequency reported
- Necropsy of survivors performed: no

Statistics:

The LD50's were computed by the method of Litchfield & Wilcoxon (1949), slope function and confidence limits were also reported.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

44 750 mg/kg bw

Based on:

test mat.

95% CL:

>= 33 650 - < 59 520

Mortality:

One animal died after 4 hours and one after 11 days.

Clinical signs:

Depression, scrawny appearance, rough, wet fur.

Body weight:

No data

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

In this acute oral toxicity test an LD50 of 44,750 mg/kg bw was determined. Based on these results, Cedryl acetate does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

In this study, 10 rats (5 males and 5 females) were treated with Cedryl acetate via oral gavage. Observation period was 14 days after treatment and toxic signs and mortality were reported. An LD50 is calculated based on the results. Two animals died during the study, one after 4 hours and one after 11 days. The rats showed depression, scrawny appearance, rough and wet fur during the observation period. The acute oral LD50 for the substance in male and female rats was calculated to be 44,750 mg/kg bw, with a 95% Confidence Interval of 33,650-59,520 mg/kg bw. Based on the results of this study, Cedryl acetate does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).