Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The summary report is taken from IPCS Environmental Health Criteria 172 (WHO), which is a relayble internationally accepted sorce. The study was conducted by GLCC in 1987. GLP and specific guidelines are not available.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Mice were administered levels of 200 or 2000mg/kg bw per day in their diet for 90 days.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
NA

Test animals

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

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on oral exposure:
Mice were administered levels of 200 or 2000mg/kg bw per day in their diet for 90 days
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Daily feed
Doses / concentrations
Remarks:
Doses / Concentrations:
200 or 2000mg/kg bw per day
Basis:
nominal in diet
No. of animals per sex per dose:
NA
Details on study design:
NA

Examinations

Observations and examinations performed and frequency:
At least gross pathological examination and mortality.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
At the end of the study, no deaths had occured at either level. No abnormal symptoms were observed in the gross pathological examination.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
clinical signs
mortality
gross pathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No deaths, no abnormal symptoms were observed during 90 day study.
Executive summary:

Mice were administered levels of 200 or 2000mg/kg bw per day in their diet for 90 days. At the end of the study no deaths occurred at either dose level. No abnormal symptoms were observed in the gross pathological examination. Hence the NOAELwas greater than 2000 mg/kg/day