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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar SPF
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw

Any other information on results incl. tables

Mortality

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Male: 10000 mg/kg bw, Number of animals: 5; Number of deaths: 0

Male: 15000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 10000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs

Signs of toxicity related to dose levels: No effects were observed

Gross pathology

Effects on organs: Macroscopically no changes were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 10000 mg/kg bw