Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: part of the SNIF file, no further data
Rationale for reliability incl. deficiencies:
other: Part of the SNIF file, which was accepted by the UK national authority for NONS

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
Guideline:
other: Annex V (Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Sprague-Dawley)

Administration / exposure

Vehicle:
other: None
No. of animals per sex per dose:
Main study: 5 (female)
Details on study design:
Preliminary sighting study:
Not applicable

Results and discussion

Preliminary study:
mg/kg bw: Evident toxicity: ; Mortality:
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: 2000 mg/kg bw (fixed dose further)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 1
Dose descriptor:
other: 2000 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 4
Clinical signs:
Signs of toxicity:
There were no signs of systemic toxicity.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy
Other findings:
All animals showed expected gains in bodyweight.

Any other information on results incl. tables

Part of the SNIF file, which was accepted by the UK national authority for NONS

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information