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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Fragrance material review on fenchyl alcohol
Author:
Bhatia S P
Year:
2008
Bibliographic source:
Food and Chemical Toxicology, 46 (2008), pp 157-159

Materials and methods

Principles of method if other than guideline:
No data on test method
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2050, 2560, 3200, 4000 and 5000 mg/kg bw.
No. of animals per sex per dose:
2 animals for doses of 2050, 2560 and 4000 mg/kg bw
3 animals for dose of 3200 mg/kg bw
5 animals for dose of 5000 mg/kg bw
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 050 mg/kg bw
Based on:
test mat.
Mortality:
All deaths occurred between days 1 and 3.
At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw.
Clinical signs:
Clinical signs included lethargy, ataxia, tearing, comatose and flaccid (no further details were reported).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance was found to be 2050 mg/kg bw in rats.
Executive summary:

The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw.