Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
7 days/week, 13 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
600mg/kg/d, 120mg/kg/d, 25mg/kg/d, 0mg/kg/d
Basis:
nominal in diet
No. of animals per sex per dose:
12 females, 12 males

Examinations

Observations and examinations performed and frequency:
observe the performances envey morning and afternoon

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
organ coefficient is increased in spleen, kidney and brain

Effect levels

open allclose all
Dose descriptor:
NOEL
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
Dose descriptor:
NOAEL
Effect level:
3.2 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs

Target system / organ toxicity

Critical effects observed:
yes
Lowest effective dose / conc.:
9.9 mg/kg bw/day (nominal)
System:
hepatobiliary
Organ:
liver
kidney
heart
spleen
brain
Treatment related:
yes
Dose response relationship:
yes

Applicant's summary and conclusion