Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
From June to July 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HAN: WIST (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No animal died in the course of the study.The single oral application of 2 g/kg of test substance was tolerated by 2 of 3 animals of each sex without any clinical findings. One male and one female animal showed slight apathy on the application day.All animals were without clinical symptoms from day 2 onwards. The body weight gain on days 7 and 14 was within or slightly above the normal range for rats of this age and strain, which are routinely used in the laboratory.Autopsy revealed no compound-related findings.

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 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy was observed in one male and one female on the application day. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.