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:
other: No OECD guideline available at the study performance date.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List V
Author:
Smyth HF
Year:
1954
Bibliographic source:
Archives of Industrial Hygiene and Occupational Medicine vol 10, pp 61-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
not specified
Details on test animals and environmental conditions:
body weights: 90-120 g
food: Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
animals non-fasted
dosages arranged in a logarithmic series differing by a factor of 2
observation period: 14 days p.a.
Statistics:
Method of Thompson-Weil for the calculation of the LD50 value

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
29 200 mg/kg bw
Based on:
test mat.
Mortality:
no data
Clinical signs:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50, oral, rat was 29.2 g per kg body weight when administered by gavage.
Executive summary:

The test substance was administered to groups of 5 rats each. Mortality was recorded during an observation period of 14 days p.a. The LD50, calculated by the method of Thompson and Weil, was 29.2 g per kg body weight.