Registration Dossier

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

Constituent 1
Chemical structure
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).