Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-976-4 | CAS number: 728-88-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,4'-dimethyl-3-piperidinopropiophenone hydrochloride
- EC Number:
- 222-876-5
- EC Name:
- 2,4'-dimethyl-3-piperidinopropiophenone hydrochloride
- Cas Number:
- 3644-61-9
- Molecular formula:
- C16H23NO.HCl
- IUPAC Name:
- 1-[2-methyl-3-(4-methylphenyl)-3-oxopropyl]piperidinium chloride
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Duration of treatment / exposure:
- 30 day
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 30 male, 30 female
Examinations
- Observations and examinations performed and frequency:
- Clinical signs were observed daily, body weight and food consumption were measured weekly and at the completion of treatment period blood samples were taken for haematological and clinical chemistry examinations. At the end of the study, animals were necropsied and major organs were weighed and tissues examined microscopically.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Description (incidence and severity):
- All animals treated with 800 mg/kg/day exhibited signs including ataxia, clonic convulsions and respiratory paralysis about 20 minutes after dosing. All animals in this dose group died during the first week of treatment, deaths occurring within 1-3 hours of dosing. In the 500 mg/kg/day dose group, ataxia and tonic-clonic convulsions were also observed and some animals died near the end of the study, though the report does not state the number of deaths. Animals treated at 200 mg/kg/day showed signs of restlessness such as irritability and an increase of spontaneous locomotor activity, while animals of the 50 mg/kg/day dose group did not exhibit any abnormal clinical signs.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not measured/tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
