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:
other: GLP study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Tif: RAIF (SPF)
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5 % (w/v) carboxy methylcellulose in 0.1 % w/v acqueous polysorbate
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number fo animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number fo animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose leves:
Only common symptoms such as piloerection, hunched posture and dyspnea were observed during the study.
Gross pathology:
Effects on organs:
No deviation from normal morphology was observed at autopsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU