Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: other route
Remarks:
other: no data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
other:
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:
other: no data
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: unknown
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
No. of animals per sex per dose:
no data

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

28 day dose showing no toxic effect: 1000 mg/kg; no effect dose given or invalid for 28 day test; no limit test field given for 28 day test.

No toxic effect dose given or invalid for 90 day test; no effect dose given or invalid for 90 day test; no limit test field given for 90 day test.

Applicant's summary and conclusion

Conclusions:
28 day dose showing no toxic effect: 1000 mg/kg