Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Albino rats, Chbb:THOM
Sex:
male/female

Administration / exposure

Route of administration:
other: Ultra Asept syringe and stomache tube
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
After the administration of 2000 mg/kg of the test compound increased nervousness, tremor, and disclored yellow urine were recorded in males and females.
Body weight:
The body weight development of male and female animals was decreased in the first week post administration of the compound.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: German Chemicals ACT
Conclusions:
The compound SND 919 Propionylthiazol revealed a very low acute toxicity after peroral administration in rats, as can be documented by the maximum nonlethal dose established:
Maximum non lethal dose: m 2000 mg/kg, f 2000 mg/kg.
With an approximate LD50 >> 2000 mg/kg after oral administration in rats the compound SND 919 Propionylthiazol could be classified as nontoxic according the German Chemicals Act (Chemikaliengesetz). Thus no labelling is necessary.