Registration Dossier
Registration Dossier
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EC number: 701-186-2 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD guideline 422. GLP study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
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:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- EC Number:
- 701-340-9
- Molecular formula:
- |Na+6-x+y+z (S2•-)y(S3•-)z|[Al6-x Si6+x O24] - SOD Where: 6 ≤ 6-x+y+z ≤ 8 0 ≤ x ≤ 1.2 1 ≤ y+z ≤ 2
- IUPAC Name:
- Sodium polysulfide aluminosilicate with a SOD-type framework structure
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: a blue powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1.0% Methylcellulose
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 42 Days for males14 Days before mating to day 4 of lactation for females
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 12 male animals per group12 female animals per group
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- GENERAL STATE: Yes (appearance, behaviour, mortality)- Time schedule: Daily DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: Before and after treatment, once a week. BODY WEIGHT: Yes - Time schedule for examinations: WeeklyFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes- Time schedule for examinations: Weekly
- Oestrous cyclicity (parental animals):
- - Estrous cycle
- Sperm parameters (parental animals):
- - Number of cells in seminiferous epithelia, testis weight, seminal vesicle weight and epididymis weight.
- Litter observations:
- PARAMETERS EXAMINEDThe following parameters were examined in offspring:number of pups born, delivery index (%), number of pups alive on Day 0 of lactation, live birth index (%), sex ratio, number of pups alive on Day 4 of lactation, viability index (%), body weight of live pups on Day 0. GROSS EXAMINATION OF DEAD PUPS:yes, for external and internal abnormalities
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes ORGAN WEIGHTS: YesHISTOPATHOLOGY: Yes
- Postmortem examinations (offspring):
- GROSS NECROPSY: yes
- Reproductive indices:
- Copulation index Fertility index Implantation indexGestation index
- Offspring viability indices:
- - Viability index
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)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- maternal toxicity
- Effect level:
- >= 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction toxicity
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- 99.5%
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- 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)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- offspring development
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The results were:-NOAEL maternal toxicity >= 300 mg/kg bw /day-NOAEL reproductive toxicity>= 1000 mg/kg bw/day-NOAEL offspring development >= 1000 mg/kg bw/day
- Executive summary:
The aim of the test was to study the reproductive and developmental toxicity in rats (12 males and 12 females) in a combined repeated dose toxicity study with the reproductive / developmental toxicity screening test at doses of 100, 300 and 1000 mg/kg bw/day.
The test was performed according to OECD Test Guideline 422.
The results were:
-NOAEL maternal toxicity >= 300 mg/kg bw /day
-NOAEL reproductive toxicity>= 1000 mg/kg bw/day
-NOAEL offspring development >= 1000 mg/kg bw/day
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