Registration Dossier
Registration Dossier
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EC number: 806-591-9 | CAS number: 175481-37-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxypropylmethylcellulose gel
- Duration of treatment / exposure:
- 26 weeks
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 90 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 180 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent no treatment
- Clinical signs:
- effects observed, treatment-related
- 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 examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly increase at 180 mg/kg bw/day exposure level
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Total cholesterol plasma level and ALAT activity increased at 180 mg/kg bw/day exposure level
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Increase observed at 180 mg/kg bw/day exposure level
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- reduced motility and apathy in rats
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 90 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: in the 30 and 90 mg/kg bw/day there were no clinical signs
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 180 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 180 mg/kg bw/day (actual dose received)
- System:
- central nervous system
- Organ:
- salivary glands
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- A NOAEL of 90 mg/kg bw/day was determined in a 6 months exposure trail .
At 180 mg/kg bw/day clinical effects were observed. these were increased salivation, reduced motility and apathy in rats
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 90 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- System:
- gastrointestinal tract
- Organ:
- salivary glands
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
