Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity 99.2%, Solid. The test article was suspended in standard suspending vehicle by means of a homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer.

Test animals

Species:
rat
Strain:
other: SPF
Sex:
female
Details on test animals and environmental conditions:
Number of animals: 20
Body weight at treatment start: 110-124
Age at treatment start: about 6weeks
General condition: Air-condition room
Air-temperature: 20-24 degree
Relative air humidity: 45-65%
Light cycle: Artificial light for 12 hours and darkness for 12 hours per day
Diet: NAFAG standard rat maintenance diet, No. 850
water: tap water

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard suspending vehicle
Details on oral exposure:
The animials were weighed and then the test article was adminstered on a mg/kg body weight base in a single dose by gavage using a stomach tube. Fee was again presented approximately 3 hours after dosing
Doses:
500, 900, 1100 or 1300 mg/kg.
No. of animals per sex per dose:
1
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 067.4 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria