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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
Study period:
March 28, 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The reliability assigned to this study is 4 as the composition of the active ingredient in the test item is low.

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif RAlf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LIMITED
- Weight at study initiation: from 105 to 115 grams
- Fasting period before study: animals fasted overnight before treatment
- Housing: in groups of 5 in Macrolon cages
- Diet (e.g. ad libitum): standard diet of pellets - No. 890, Nafag Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Doses:
1000, 3000, 10000, 15000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Other examinations performed: clinical signs, body weight,organ

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occured
Clinical signs:
At 10000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia. Symptoms lasting >6 hours. After 24 hours no symptoms.
At 15000 mg/kg bw: ditto, diarrhea.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 15000 mg/kg bw
Executive summary:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 15 days is >15000 mg/kg bw.