Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test compliant with GLP and Guideline OECD 401

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% CMC and 0.1% polysorbate 80
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:
1 984 mg/kg bw
Mortality:
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 4000 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 5 mg/kg bw; Number of animals: ; Number of deaths: 2
Female: 5 mg/kg bw; Number of animals: ; Number of deaths: 3
Female: 5 mg/kg bw; Number of animals: ; Number of deaths: 5
Clinical signs:
Signs of toxicity related to dose levels:
Unspecific symptoms of toxicity, reversible after 19 days in the surviving animals of the 2000 mg/kg group and after 13 days in the animals of the 1000 mg/kg group.
Gross pathology:
Effects on organs:
2 animals of the 4000 mg/kg group showed spotted lungs. 1 animal of the 1000 mg/kg group exhibited bilateral eye opacity, which was not reversible during the observation period. various animals showed skin erythema and alopezia.
After 3 weeks hair started to grow again in the effected area.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU