Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ATC-Methode (Acute Toxic Class Methode) E.Schlede, U.Mischke R.Roll, D.Kayser: "A national validation study of the acute- toxic-class methode..." Arch. Toxicol. 66: 455-470 (1992)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Doses:
Male: 2200 mg/kg bw
Female: 2200 mg/kg bw
No. of animals per sex per dose:
Male: number of animals 3
Female: number of animals 3
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Based on:
not specified
Mortality:
Male: 2200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Gross pathology:
Effects on organs: Without findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 (male/female) > 2200 mg/kg bw