Registration Dossier
Registration Dossier
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EC number: 215-709-2 | CAS number: 1344-81-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Polisenio
- Type of information:
- experimental study
- Remarks:
- sub-chronic toxicity oral
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Calcium sulfide (Ca(Sx))
- EC Number:
- 215-709-2
- EC Name:
- Calcium sulfide (Ca(Sx))
- Cas Number:
- 1344-81-6
- Molecular formula:
- CaSx (X=2,3,4,5,6,7)
- IUPAC Name:
- Calcium sulfide (Ca(Sx)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Toxi-Coop Ltd.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- See it in the attachement. Appendix 2.11 Page 6 and 7
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- 0 mg/ml
- Dose / conc.:
- 75 mg/kg bw/day (nominal)
- Remarks:
- 7.5 mg/ml
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Remarks:
- 15 mg/ml
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- Remarks:
- 35 mg/ml
- No. of animals per sex per dose:
- 10 animal /sex/dose additinal 5 males and females in the control and high dose groups for recovery. See it in
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- See it in the summary of the attached document page 8.
- Sacrifice and pathology:
- See it in the summary of the attached document page 8.
- Statistics:
- SPSS
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- See it in page 9.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- See it in the attachement page 9
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- See it in the attachement page 9
- 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):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- mortality
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 350 mg/kg bw/day (nominal)
- System:
- cardiovascular
- Organ:
- not specified
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) of calcium polisuphide (lime sulphur) was established as 150 mg/kg bw/day,
- Executive summary:
The no observed adverse effect level (NOAEL) of calcium polisuphide (lime sulphur) was established as 150 mg/kg bw/day,
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