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:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three fasted female Fisher 344 rats received 2000 mg/kg of neat test material by single dose gavache. Clinical signs and mortality were observed.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg b.v.
No. of animals per sex per dose:
3 female
Control animals:
no
Details on study design:
Three fasted female Fisher 344 rats received 2000 mg/kg of neat test material by single dose gavache. Clinical signs and mortality were observed.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 800 mg/kg bw
Based on:
act. ingr.
Mortality:
One animal died at test day 8
Clinical signs:
Various combinations of urine or fecal perineal soiling, decreased activity, red or clear periocular soiling, red perinasal soiling, arched back postures, pale eyes and moderate incoordination. All clinical signes for surviving animals resolved by the test day 3 and 7.
Body weight:
One surviving animal lost weight and one gained weight during the test.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria