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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The no observed adverse effect level (NOAEL) of calcium polisuphide (lime sulphur) was established as 150 mg/kg bw/day,

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
Wistar
Details on species / strain selection:
Toxi-Coop Ltd.
Sex:
male/female
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
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
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
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
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
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
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,

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Klimisch 1
System:
cardiovascular
Organ:
not specified

Additional information

Justification for classification or non-classification