Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive CEE - Méthode B1 ter et OCDE 423.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Flask Lot 4X546
Batch 4X546
Supplier : CIT
Specific details on test material used for the study:
Lot DSC-9401

Test animals

Species:
other: Rat, Sprague-Dawley

Administration / exposure

Vehicle:
other: Purified water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels : no clinical sign and no mortality were observed during the study


L'évolution pondérale des animaux n'est pas influencée par
le traitement avec la substance.
Gross pathology:
Effects on organs: no apparent anomalies are observed during the macroscopic examination of the main organs of sacrificed animals at the end of the study

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU