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Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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.
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
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
NA
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
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
Observations and examinations performed and frequency:
At least gross pathological examination and mortality.
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.
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
Critical effects observed:
not specified
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
Species:
mouse

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Information available

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Waiver including justification

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Waiver including justification

Justification for classification or non-classification

The test material does not meet the criteria for classification and labelling under Annex VI of Council Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.