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Diss Factsheets
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EC number: 233-484-9 | CAS number: 10196-04-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratologic Evaluation of Compound FDA 71-22, Sodium Metabisulfite in Rabbit
- Author:
- Anonymous
- Year:
- 1 974
- Bibliographic source:
- National Technical Information Service (NTIS), U.S. Department of Commerce, PB-267 194, July 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- disodium disulfite
- IUPAC Name:
- disodium disulfite
- Reference substance name:
- Disodium disulphite
- EC Number:
- 231-673-0
- EC Name:
- Disodium disulphite
- Cas Number:
- 7681-57-4
- IUPAC Name:
- disodium disulphite
- Reference substance name:
- sodium metabisulphite
- IUPAC Name:
- sodium metabisulphite
- Details on test material:
- - Name of test material (as cited in study report): Sodium metabisulfite, FDA 71-22
- Molecular formula (if other than submission substance): Na2S2O5
- Physical state: solid, white crystalline material
No further details are given.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: virgin, adult
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
No further details are given.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): doses administered as a water solution of 1 mL/kg body weight. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- - Impregnation procedure: artificial insemination.
- On day 0, each doe was given an injection of 0.4 mL of human chorionic gonadotropin (400 IU) via the marginal ear vein.
- 3 hours later, each doe was inseminated artificially with 0.3 mL of diluted semen from a proven donor buck using approximately 20 x 10^6 motile sperm. - Duration of treatment / exposure:
- from gestation day 6 to 18
- Frequency of treatment:
- daily
- Duration of test:
- until day 29 of gesation
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.23 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5.71 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
26.5 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
123 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4 treatment groups with 15 to 20 mated females
- Control animals:
- yes, sham-exposed
- other: 2.5 mg/kg body weight of 6-aminonicotinamide dosed on Day 9 (positive control)
- Details on study design:
- No further details are given.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: all animals were observed daily for appearance and behaviour.
BODY WEIGHT: Yes
- Time schedule for examinations: recorded on days 0, 6, 12, 18 and 29 of gestation.
FOOD CONSUMPTION: Yes
- Time schedule: all animals were observed daily with particular attention to food consumption.
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: all does 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 and sex of live and dead fetuses: Yes - Fetal examinations:
- External examinations: Yes
- Body weights of the live pups were recoded.
- All fetuses underwent a detailed gross examination for the presence of external congenital abnormalities.
Soft tissue examinations: Yes
- The live fetuses of each litter were then placed in an incubator for 24 hours for evaluation of neonatal survival.
- All surviving pups were sacrificed, and all pups examined for visceral abnormalities (by dissection).
Skeletal examinations: Yes
- All fetuses 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 - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
- The pregnancy rates was comparable among groups and survival of pregnant females was not affected by treatment with sodium metabisulphite.
- Maternal body weights and weight gains were comparable among groups.
- There were no treatment-related effects on the number of abortions, corpora lutea, implantation sites, live litters and resorptions.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 123 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- NOAEL
- Effect level:
- > 123 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- The number of live and dead fetuses, sex ratio and average fetal weight was not affected by treatment of dams with sodium metabisulphite.
- 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)
- Dose descriptor:
- NOAEL
- Effect level:
- > 123 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 123 mg/kg bw/d of sodium metabisulphite to pregnant rabbits for 13 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 123 mg/kg body weight sodium metabisulphite in this rabbit study.
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