Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
2011
Reference Type:
grey literature
Title:
No information
Year:
1979
Bibliographic source:
Gekkan Yakuji. Pharmaceuticals Monthly, 1979, 21, 2117

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No data on materials and methods are reported in the RTECS database. It was not possible to obtain the japanese written original article. Thus, the use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 500 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Details of toxic effects not reported.

It was reported only the disclosed value, also in the original paper.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Because of LD50 > 4500 mg/kg bw Betamethasone was considered non toxic for acute oral administration.