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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data from sds

Data source

Reference
Reference Type:
other: sds
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Potassium sulfate
EC Number:
231-915-5
EC Name:
Potassium sulfate
Cas Number:
7778-80-5
Molecular formula:
H2O4S.2K
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
other: no data
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
Exposure time for Male is 28 days
Exposure time for female is 53 days
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Exposure time for Male is 28 days
Exposure time for female is 53 days
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
NO DATA
Positive control:
NO DATA

Examinations

Parental animals: Observations and examinations:
NO ADVERSE SYSTEMIC EFFECTS OBSERVED
Oestrous cyclicity (parental animals):
NO ADVERSE SYSTEMIC EFFECTS OBSERVED
Sperm parameters (parental animals):
NO ADVERSE SYSTEMIC EFFECTS OBSERVED
Litter observations:
NO ADVERSE SYSTEMIC EFFECTS OBSERVED
Postmortem examinations (parental animals):
NO DATA
Postmortem examinations (offspring):
NO DATA
Statistics:
NO DATA
Reproductive indices:
NO DATA
Offspring viability indices:
NO DATA

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
>= 1 500 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
clinical signs
Remarks on result:
other: Generation: NO DATA (migrated information)

Results: P1 (second parental generation)

Effect levels (P1)

Dose descriptor:
other:
Effect level:
other:
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not determined
Remarks on result:
not determinable due to absence of adverse toxic effects

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified

Details on results (F1)

NO DATA

Effect levels (F1)

Dose descriptor:
other: not determined
Generation:
other: not determined
Effect level:
other: Not determined
Based on:
other: not determined
Sex:
not specified
Basis for effect level:
other: not determined
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (F1)

Critical effects observed:
not specified
System:
other: not determined
Organ:
other: not determined
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Results: F2 generation

Effect levels (F2)

Dose descriptor:
other: not determined
Generation:
other:
Effect level:
other: not determined
Based on:
other: not determined
Remarks:
not determined
Sex:
not specified
Basis for effect level:
other: not determined
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (F2)

Critical effects observed:
not specified
System:
other: not determined
Organ:
other:
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NO ADVERSE SYSTEMIC EFFECTS
Executive summary:

NO ADVERSE SYSTEMIC EFFECTS