Registration Dossier
Registration Dossier
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EC number: 942-582-7 | CAS number: -
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented, acceptable study according to GLP principles. No details about test substance purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium sulfate (K2SO4)
- IUPAC Name:
- Potassium sulfate (K2SO4)
- Details on test material:
- Potassium Sulfate (K2SO4)
No details on purity
Due to a shortage of test substance, additional substance with equivalent composition was obtained and used in the latter phase of the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals in the study were divided between two subgroups (toxicity and reproductive subgroups). The exposure period for males and females in the toxicity subgroup was 28 days. The exposure period for reproductive subgroup males was at most 28 days. The exposure period for reproductive subgroup females was at most 53 days (14 days pre-mating, 14 days mating, and gestational and lactational periods up to lactation day 4).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Doses: 0, 50, 750, and 1,500 mg/kg/day
(Doses were selected based on parameters assessed in a range-finding study at concentrations up to 1,000 mg/kg/day)
Frequency of Treatment: Daily - Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
- Details on study schedule:
- Reproductive subgroup: Male rats (5 males) in the reproductive subgroup were administered K2SO4 for 28 days via oral gavage. Female rats (10 females) in the reproductive subgroup were administered K2SO4 for a period encompassing approximately 53 continuous days via oral gavage: 14 days of initial treatment, plus a maximum of 14 days of cohabitation to ensure mating, and 25 days to litter and rear their young until Day 4 of age. Histology for reproductive subgroup animals was restricted to retained reproductive organs (and any other abnormalities observed at necropsy).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 750, and 1,500 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- no data
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- no data
- 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
Details on results (P0)
Reproductive subgroup: There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Mating performance and fertility were unaffected by treatment. All animals mated within 4 days.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction/developmental toxicity
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested: no effects
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
There were no treatment-related effects on gestation length, gestation index, litter size, offspring survival indices, sex ratio, offspring bodyweight, or macropathology for offspring.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested: no effects
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were seen on reproduction/developmental toxicity endpoints.
NOAEL = 1500 mg/kg/day (reproduction/developmental toxicity)
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