Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment. Published paper giving a very brief summary.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2011

Materials and methods

Principles of method if other than guideline:
No guideline or details of method given in the publication
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none given

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
"approximately 3 months"
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
26 mg/kg bw/day and unspecified lower doses
Basis:
actual ingested
No. of animals per sex per dose:
no details
Control animals:
not specified

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
26 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No toxicity observed

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No treatment-related findings were reported.

Applicant's summary and conclusion

Conclusions:
A very limited published report of a three-month oral study in rats, conducted to GLP but with no stated guideline, found no toxicity at the highest tested dose of 26 mg/kg bw/day.