Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
unknown
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Only abstract with species and LD50 value given.
A handwritten report is available, language japanese
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Specific details on test material used for the study:
not available

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not available
Doses:
not available
No. of animals per sex per dose:
not available
Control animals:
not specified
Details on study design:
not available
Statistics:
not available

Results and discussion

Preliminary study:
not available
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Mortality:
description not available
Clinical signs:
description not available
Body weight:
description not available
Gross pathology:
description not available
Other findings:
description not available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An LD50 (orally in mice) is available, it is stated to be over 6000 mg/kg bw.