Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

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:
rat
Strain:
other: TiF:RAlf (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
male/female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Unspecific symptoms of intoxication: piloerection, hunched posture, exophthalmus and dyspnoea
Body weight:
no data
Gross pathology:
Effects on organs: No effects

Applicant's summary and conclusion

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