Registration Dossier
Registration Dossier
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EC number: 244-617-5 | CAS number: 21850-44-2
Endpoint summary
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
- 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 or test system 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
- gross pathology
- mortality
- 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
Reference
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
- Endpoint:
- sub-chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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