Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: short abstract

Data source

Reference
Reference Type:
publication
Title:
Acute toxicologic evaluation of aldadiene
Author:
McLain DE et al.
Year:
1990
Bibliographic source:
J. American College Toxicology, Part B. Vol. 1, pp. 36-37, 1990

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
- Application volume: 10 ml/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No remarkable clinical signs.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at the limit-dose 5000 mg/kg was tolerated without remarkable clinical signs (LD50 > 5000 mg/kg body weight).