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: guideline study according to GLP

Data source

Reference
Reference Type:
other: SNIF data
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(24. Feb 1987)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: RAI f SPE
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% (w/v) CMC in 0.1% (w/v) aqueous polysorbate 80

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 of animals: 5; number of deaths: 0
female: 2000 mg/kg bw; number of animals: 5; number of deaths: 0
Clinical signs:
signs of toxicity related to dose levels:
piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests
Gross pathology:
effects on organs:
spotted lungs were found in one female. No treatment related abnormalities were observed in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The presented data were accepted by authorities in the context of substance notification according to the Council Directive 67/548/EEC.