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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline with acceptable restrictions (limited information on test substance, applied volume (1.5 mL/100 g bw) exceeds the recommended value).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Adopted 24 February 1987
Deviations:
yes
Remarks:
limited information on test substance, applied volume (1.5 mL/100 g bw) exceeds the recommended value
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent
- Weight at study initiation: males: 247.2 g ± 3.4 g, females: 201.2 g ± 9.0 g
- Fasting period before study: overnight before dosing
- Housing: in single sex groups in polypropylene cages
- Diet: smodified 41B diet, Pilsbury´s Limited, Birmingham, UK, ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
controlled temperature and lighting conditions

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
VEHICLE
- Amount of vehicle: 15 mL/kg bw
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg bw
Doses:
10.000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were examined immediately and 4 h after dosing and then daily.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
All the rats were hypoactive at the 4 h observation period. No further signs of toxicity were noted during the study period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.