Registration Dossier
Registration Dossier
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EC number: 300-344-4 | CAS number: 93925-42-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- stuy older than guidelines, methods and princilple see attached report
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyltin di(acetate)
- EC Number:
- 213-928-8
- EC Name:
- Dibutyltin di(acetate)
- Cas Number:
- 1067-33-0
- Molecular formula:
- C12H24O4Sn
- IUPAC Name:
- dibutyltin di(acetate)
- Details on test material:
- - Name of test material : dibutyltin acetate Bu2Sn(OAc)2
- Radiochemical purity (if radiolabelling): >99 %
- Specific activity (if radiolabelling): 6.3 Ci/mmol
Unlabeled R2Sn (OAc)2, derivatives (prepared as needed by photodecomposition of R4Sn compounds on silica gel chromatoplates and TLC isolation); 1-14C-labeled preparations of Bu2Sn(OAc), with a specific activity of 6.3 mCi/mmol, and >99% radiochemical purity
- Name of test material : Bu2SnCl2 (unlabelled Bu2SnX2)
Constituent 1
Test animals
- Species:
- other: mice, rat
- Strain:
- other: Fischer 344 rats and B6C3F1 mice
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- rats: 78 wks
mice 52 wks - Frequency of treatment:
- daily in diet
Doses / concentrationsopen allclose all
- Dose / conc.:
- 70 mg/kg diet
- Remarks:
- rat
- Dose / conc.:
- 100 mg/kg diet
- Remarks:
- rat
- Dose / conc.:
- 145 mg/kg diet
- Remarks:
- rat
- Dose / conc.:
- 315 mg/kg diet
- Remarks:
- rat
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- rat, mice
- Dose / conc.:
- 17 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 25 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 37 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 55 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 80 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 255 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 375 mg/kg diet
- Remarks:
- mice
- Dose / conc.:
- 650 mg/kg diet
- Remarks:
- mice
- No. of animals per sex per dose:
- see attached study report
- Control animals:
- yes, plain diet
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- rats: Tarone test for association between dosage and mortality was significant for males (P < 0.001) but not for females.
cie: Tarone test for association between dosage and mortality was significant for female mice (P < 0.001) but not for male
mice. - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Description (incidence and severity):
- see report
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- see report
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- see report
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- see report
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 132 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- rat
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 152 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- mice
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
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.
