Registration Dossier
Registration Dossier
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EC number: 233-596-8 | CAS number: 10257-55-3
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: virgin adult female albino rats
- Housing: individually housed in mesh bottom cages
- Diet (ad libitum)
- Water (ad libitum): fresh tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): doses administered as a water solution. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- nto specified
- Details on mating procedure:
- - Impregnation procedure: cohoused; females were mated with young adult males (one male was not permitted to impregnate more than one female per group)
- Proof of pregnancy: vaginal sprem plug was considered day 0 of gestation - Duration of treatment / exposure:
- day 6 to 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 20 of gesation
- Dose / conc.:
- 1.55 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 7.19 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 33.4 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 155 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 22 - 25 mated animals
- Control animals:
- yes, concurrent vehicle
- other: positive control: 250 mg/kg body weight of Aspirin
- Details on study design:
- not specified
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: mortality, appearance and behaviour
DETAILED CLINICAL OBSERVATIONS:No data
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 11, 15 and 20 of gestation
FOOD CONSUMPTION: Yes
- Time schedule: daily
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- all dams were subjected to Caesaren section under surgical anesthesia. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of live and dead foetuses: Yes - Fetal examinations:
- External examinations: Yes
- All foetuses underwent a gross examination for the presence of external congenital abnormalities. .
Soft tissue examinations: Yes
- One-third of the foetuses of each litter underwent detailed visceral examinations employing the Wilson technique.
Skeletal examinations: Yes
- Two-third of the foetuses were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects (sternebrae, ribs, vertebrae, skull, extremities and miscellaneous)
Head examinations: No data
- Body weights of the live pups were recoded.
- Sex of the foetuses was recorded - Statistics:
- not specified
- Indices:
- not specified
- Historical control data:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- - The survival of pregnant females was not affected by treatment with potassium metabisulfite.
- Maternal body weights and weight gains were comparable among groups. - Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Other effects:
- not specified
- Details on maternal toxic effects:
- - The pregnancy rates was comparable among groups (control group: 23 pregnant rats; 1.55 mg/kg bw/d: 20 pregnant rats; 7.19 mg/kg bw/d: 20 pregnant rats; 33.4 mg/kg bw/d: 20 pregnant rats; 155.0 mg/kg bw/d: 20 pregnant rats).
- There were no treatment-related effects on the number of abortions, corpora lutea, implantation sites, live litters and resorptions. - Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- - The number of live and dead foetuses, sex ratio and average foetal weight was not affected by treatment of dams with potassium metabisulfite.
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. - Key result
- Dose descriptor:
- NOAEL
- Remarks:
- teratogenicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration of up to 155 mg/kg bw/d of potassium metabisulfite to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. Thus, the NOAEL for maternal and developmental toxicity can be expected above the highest dose of 155 mg/kg body weight potassium metabisulfite in this rat study.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- not specified
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: virgin adult female albino mice
- Housing: individually housed in disposable plastic cages
- Diet (ad libitum)
- Water (ad libitum): fresh tap water - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): test item was administered as a water solution (1.0 mL/kg of body weight). - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused; females were mated with young adult males.
- Proof of pregnancy: vaginal plug considered as day 0 of gestation - Duration of treatment / exposure:
- day 6 to 15 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 17 of gestation
- Dose / conc.:
- 5.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 25.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 118 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 550 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 24 - 29 mated animals
- Control animals:
- yes, sham-exposed
- other: positive control: 150 mg/kg body weight of Aspirin
- Details on study design:
- not specified
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: mortality, appearance and behaviour
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6, 11, 15 and 17 of gestation.
FOOD CONSUMPTION: Yes
- Time schedule: daily
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 17
- all dams were subjected to Caesaren section under surgical anesthesia. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of live and dead foetuses: Yes - Fetal examinations:
- External examinations: Yes
- All foetuses underwent a gross examination for the presence of external congenital abnormalities. .
Soft tissue examinations: Yes
- one-third of the foetuses of each litter underwent detailed visceral examinations employing 10x magnification.
Skeletal examinations: Yes
- Two-third of the foetuses were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects (sternebrae, ribs,vertebrae, skull, extremities and miscellaneous)
Head examinations: No data
- Body weights of the live pups were recoded.
- Sex of the foetuses was recorded - Statistics:
- not specified
- Indices:
- not specified
- Historical control data:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- - The survival of pregnant females was not affected by treatment with sodium thiosulfate.
- Maternal body weights and weight gains were comparable among groups. - Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Other effects:
- not specified
- Details on maternal toxic effects:
- - The pregnancy rates was comparable among groups (control group: 21 pregnant mice; 5.5 mg/kg bw/d : 20 pregnant mice; 25.5 mg/kg bw/d: 22 pregnant mice; 118 mg/kg bw/d: 21 pregnant mice; 550 mg/kg bw/d: 21 pregnant mice)
- There were no treatment-related effects on the number of abortions, corpora lutea, implantation sites, live litters and resorptions. - Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- - The number of live and dead foetuses, sex ratio and average foetal weight was not affected by treatment of dams with sodium thiosulfate.
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. - Key result
- Dose descriptor:
- NOAEL
- Remarks:
- teratogenicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The administration of up to 550 mg/kg bw/d of sodium thiosulfate to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. Thus, the NOAEL for maternal and developmental toxicity can be expected above the highest dose of 550 mg/kg body weight sodium thiosulfate in this mice study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium thiosulphate
- EC Number:
- 231-867-5
- EC Name:
- Sodium thiosulphate
- Cas Number:
- 7772-98-7
- Molecular formula:
- H2O3S2.2Na
- IUPAC Name:
- disodium thiosulfate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Sodium thiosulfate (FDA 71-35)
- Physical state: solid, fine white crystalline material
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- hamster
- Strain:
- other: Golden
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: virgin adult female hamsters
- Housing: individually housed in mesh bottom cages
- Diet (ad libitum)
- Water (ad libitum): fresh tap water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): test item was administered as a water solution (1 or 2 mL/kg of body weight) - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: females were mated (1 to 1) with mature males.
- Proof of pregnancy: motile sperm in vaginal smear was considered Day 0 of gestation.
- Duration of treatment / exposure:
- day 6 to 10 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 14 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 19 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 86 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 400 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 22 mated animals
- Control animals:
- yes, sham-exposed
- other: positive control: 250 mg/kg body weight of Aspirin
- Details on study design:
- not specified
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: mortality, appearance and behaviour
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 8, 10 and 14 of gestation.
FOOD CONSUMPTION: Yes
- Time schedule: daily
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 14
- all animals were subjected to Caesaren section under surgical anesthesia. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Number of live and dead foetuses: Yes - Fetal examinations:
- External examinations: Yes
- All foetuses underwent a gross examination for the presence of external congenital abnormalities. .
Soft tissue examinations: Yes
- One-third of the foetuses of each litter underwent detailed visceral examinations employing 10x magnification.
Skeletal examinations: Yes
- Two-third of the foetuses were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects (sternebrae, ribs, vertebrae, skull, extremities and miscellaneous)
Head examinations: No data
- Body weights of the live pups were recoded.
- Sex of the foetuses was recorded - Statistics:
- not specified
- Indices:
- not specified
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- - The survival of pregnant females was not affected by treatment with sodium thiosulfate.
- Maternal body weights and weight gains were comparable among groups.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Other effects:
- not specified
- Details on maternal toxic effects:
- - The pregnancy rates was comparable among groups (control group: 21 pregnant hamsters; 4.0 mg/kg bw/d: 20 pregnant hamsters; 19.0 mg/kg bw/d: 21 pregnant hamsters; 86 mg/kg bw/d: 22 pregnant hamsters; 400 mg/kg bw/d: 20 pregnant hamsters).
- There were no treatment-related effects on the number of abortions, corpora lutea, implantation sites, live litters and resorptions.
Effect levels (maternal animals)
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- - The number of live and dead foetuses, sex ratio and average foetal weight was not affected by treatment of dams with sodium thiosulfate.
- The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- teratogenicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 400 mg/kg bw/d of sodium thiosulfate to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. Thus, the NOAEL for maternal and developmental toxicity can be expected above the highest dose of 400 mg/kg body weight sodium thiosulfate in this hamster study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
