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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No histopatological evaluation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Single oral application by gavage, undiluted TS., 5 doses, observation time 14d, determination of signs of intoxication, stat.method:probit analysis.
GLP compliance:
not specified
Test type:
other:
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw
No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
200 mg/kg bw
Based on:
not specified
Mortality:
Dose: number of dead rats (time of death)// number of rats with symptoms
0.16 ml/kg bw: 0/10 (-) // 10/10
0.18 ml/kg bw: 1/10 (3h) // 10/10
0.20 ml/kg bw: 5/10 (3h) // 10/10
0.25 ml/kg bw: 7/10 (3h) // 10/10
0.30 ml/kg bw: 10/10 (2h-2d) // 10/10
Clinical signs:
tonical cramps, sedation, poor general condition
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 200 mg/kg bw.
Executive summary:

The oral LD50 in the rats was 200 mg/kg bw. Signs of intoxication were tonical cramps, sedation, poor general condition