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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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Cetiol OE
- Physical state: liquid
- Analytical purity: >99.9%
- Lot/batch No.: 7/91

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
other: oral by means of a stomach tube
Vehicle:
arachis oil
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no effects
Body weight:
no effects
Gross pathology:
no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50>2000 mg/kg body weight
Executive summary:

The acute oral toxicity of the test substance was investigated in young adult Wistar rats according to OECD guideline 401. The test article was dissolved in arachidis oil and given orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days, the rats were observed for any signs of reaction. The surviving rats were sacrified at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 was >2000 mg/kg for male and female rats.