Registration Dossier
Registration Dossier
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EC number: 426-370-7 | CAS number: 1017183-70-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- SOLE 2
- IUPAC Name:
- SOLE 2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Deionized water.The substance(Sole 2) was solubilized by addition of 5N NaOH solution retaining the molar ratio of 1:0.729, than made up to final volume with the vehicle.
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
No clinical abnormalities were observed in dosed animals of either sex.
Food consumptions and body weight of both males and females of the various dose groups was found to have been unaffected by treatment.
Laboratory findings:
All laboratory tests performed in this study, (hematology, blood chemistry and urinalysis) revealed no modifications of toxicological relevance in treated animals of either sex.
The only changes observed involved the males and consisted in slight reduction of the hematocrit value at 500 mg/kg/day and of the prothrombin time at 150 and 500 mg/kg/day.
Effects in organs:
Post- mortem examinations (organ weight, gross pathology and histology) did not show changes that could been caused by test article administration.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
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.
