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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:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Does not meet important criteria of today standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: US FHSA Guidelines
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hedione
- Substance type: pure active substance
- Analytical purity: ~100%
- isomers composition: ca. 10 cis- and 90 % trans- isomers

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16-18 h prior to testing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Pure substance employed (dose provided: 5g/kg)
Doses:
5 g/kg
No. of animals per sex per dose:
10 (sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently the day of the test and daily thereafter
- Necropsy of survivors performed: none (not required by FHSA guideline)
- Other examinations performed: lethality, clinical signs
Statistics:
Not Applicable (limit test)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
approximate LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no 95% CL
Mortality:
none
Clinical signs:
none
Body weight:
no data
Gross pathology:
not performed (not required by FHSA)

Applicant's summary and conclusion

Interpretation of results:
other: non toxic
Remarks:
Criteria used for interpretation of results: other: US-FHSA
Executive summary:

Acute Oral Toxicity of the test material was determined according to the U.S. -Federal Hazardous Substance Act (FHSA) Guidelines. Ten Wistar rats fasted for a period of 16 -18 hours were dosed orally with the test substance at a level of 5 g/kg bw. They were returned to their cage and given food and water ad libitum. Observations for mortality and pharmaceuticological effects were made frequently on the day of the test and daily therafter for 14 days. No necropsies were performed at termination of the study.

No death occured during the study. No relevant clinical signs were observed. The LD50 was estimated to be greater than 5.0 mg/kg.