Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

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)
Version / remarks:
(18.5.81, Paris)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif : RAIf (SPF) , F3-crosses of RII 1/Tif x RII 2/T-if
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: distilled water, containing 0.5% carboxymethylcellusole and 0.1% polysorbate 80
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels used, time of onset and duration:
Only common symptonies in acute tests were observed. The animals recovered vithin 13 days.
Dyspnea, exophthalmos, ruffled fur and curved body position were seen, being common symptomes in acute tests.
Mortality:
No deaths following a single does of 5000 mg/kg.

Effects in organs (related to dose levels):
No deviations from normal morphology.
Body weight:
no data
Gross pathology:
Effects on organs: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 >5000 mg/kg bw