Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data, List III
Author:
Smyth H.F., Carpetnter C.P. and Weil C. S.
Year:
1949
Bibliographic source:
J. Ind. Hyg. Toxicol., 31, 60-62

Materials and methods

Principles of method if other than guideline:
The single oral toxicity was determined by gastric intubation of groups of 5 non-fastened, male Carworth Wistar rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Carworth Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: reared in the oqn colony
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: animals were not fasted
- Diet (e.g. ad libitum): Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
no data, the dosages were arranged in an logarithmic series differing by a factor of 5
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4 570 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met