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:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
The animals will be housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The room temperature will be within the range of 22 ± 3°C; relative humidity will be within the range of 50 - 60 %. The light regime will be set to a 12-hour light / 12-hour dark cycle. The sanitation will be performed according to standard operation procedures.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5, 50, 300, and 2000 mg/kg body weight.
No. of animals per sex per dose:
6-9 femal

Results and discussion

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

Applicant's summary and conclusion