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

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): 44,750 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

Preliminary study:

Not applicable

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

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

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.

Justification for classification or non-classification

Based on the result of the key study, the substance does not have to be classified as acute toxic by the oral route in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).