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: GLP - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 401
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Spraque-Dawley rat

Administration / exposure

Vehicle:
corn oil

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals:5; Number of deaths:0
Female: 5000 mg/kg bw; Number of animals:5; Number of deaths:0
Clinical signs:
Signs of toxicity related to dose levels:
No significant clinical signs were produced at any time during the study.
Gross pathology:
Eiffects on organs:
No gross lesions or abnormalities were noted during necropsy

Applicant's summary and conclusion