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EC number: 231-821-4 | CAS number: 7757-83-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- 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.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of teratogenic potential of sodium sulfite in rats.
- Author:
- Itami, T. et al.
- Year:
- 1 989
- Bibliographic source:
- Drug Chem. Toxicol., 12: 123-135. (cited in OECD SIDS sodium dithionite, Oct. 2004)
- Reference Type:
- review article or handbook
- Title:
- Occupational Exposures to Mists and Vapours from Strong Inorganic Acids and Other Industrial Chemicals.
- Author:
- Anonymous
- Year:
- 1 992
- Bibliographic source:
- IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 54, 131 - 188, International Agency for Research on Cancer, Lyon
- Reference Type:
- review article or handbook
- Title:
- Safety evalutation of certain food additives. Sulfur dioxide and sulfites (addendum).
- Author:
- Anonymous
- Year:
- 1 999
- Bibliographic source:
- WHO Food Additives Series 42: 95-116.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium sulphite
- EC Number:
- 231-821-4
- EC Name:
- Sodium sulphite
- Cas Number:
- 7757-83-7
- Molecular formula:
- NA2SO3
- IUPAC Name:
- disodium sulfate
- Test material form:
- solid: crystalline
- Details on test material:
- - Supplier: Katayama Chemical Industries Co. LTD (Tokyo, Japan)- State of aggregation: colourless, efflorescent crystalline compound
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: KEARI Co. Ltd, Osaka, Japan.
- Weight at study initiation: 237 ± 2 g on day 0 of pregnancy.
- Housing: housed individually in wire-mesh cages.
- Diet (ad libitum): basal diet CE-2, Clea Japan Inc., Tokyo)
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 24 - 25 °C
- Relative humidity: 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- diet was prepared to contain the different concentrations of the test item in the basal diet. - 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; virgin female rats were caged with male rats overnight.
- Proof of pregnancy: vaginal plug and sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gestation day 8 to gestation day 20
- Frequency of treatment:
- ad libitum
- Duration of test:
- Either until gestation day 20 (10 to 12 dams per group) or until weaning on day 21 post partum (4 - 5 dams of control, 0.32% and 5% groups).
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.32 other: %
- Remarks:
- approx. 200 mg sodium sulfite heptahydrate/kg bw/day (equivalent to approx. 100 mg sodium sulfite/kg bw/day or approx. 50 mg/kg bw/day SO2 equivalent)
- Dose / conc.:
- 0.63 other: %
- Remarks:
- approx. 400 mg sodium sulfite heptahydrate/kg bw/day (equivalent to approx. 200 mg sodium sulfite/kg bw/day or approx. 100 mg/kg bw/day SO2 equivalent)
- Dose / conc.:
- 1.25 other: %
- Remarks:
- approx. 900 mg sodium sulfite heptahydrate/kg bw/day (equivalent to approx. 450 mg sodium sulfite/kg bw/day or approx. 225 mg/kg bw/day SO2 equivalent)
- Dose / conc.:
- 2.5 other: %
- Remarks:
- approx. 1750 mg sodium sulfite heptahydrate/kg bw/day (equivalent to approx. 850 mg sodium sulfite/kg bw/day or approx. 440 mg/kg bw/day SO2 equivalent)
- Dose / conc.:
- 5 other: %
- Remarks:
- approx. 2900 mg sodium sulfite heptahydrate/kg bw/day (equivalent to approx. 1450 mg sodium sulfite/kg bw/day or approx. 725 mg/kg bw/day SO2 equivalent)
- No. of animals per sex per dose:
- 10 - 12 dams/group (exception: 14 to 17 dams/group in the control, 0.32% and 5% groups)
- Control animals:
- yes, plain diet
- Details on study design:
- not specified
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: clinical signs
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule for examinations: daily
- Net amounts of sodium sulfite uptake were calculated from the food consumption.
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20; 10 or 12 pregnant rats in each group were sacrificed by cervical dislocation.
OTHER:
- 4 or 5 dams in 5%, 0.32% and control groups were individually housed and were allowed to give birth.
- After completion of delivery, maternal rats were fed basal diet without sodium sulfite; the day of delivery was designated as day 0 after birth.
- At birth, the number of live and dead newborns were recorded.
- Pups were sexed, weighed, examined for external malformations, marked for identification and allowed to suckle their own mother.
- Pups were weaned day 21 after birth.
- The body weights of maternal rats and pups were measured and clinical signs of toxicity were noted during this period. - 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: No data
- Number of implantations: Yes
- Number and position of resorptions: Yes
- Examination for the presence and position of foetuses (dead or alive) - Fetal examinations:
- - External examinations: Yes, each foetuses.
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, half per litter
- Head examinations: No data
Further examinations:
- each live foetus was weighed and sexed. - Statistics:
- Statistical analysis of the fetal data was based on the litter as the experimental unit. The maternal body weight gain and food consumption during pregnancy, the number of implantations, live fetuses, live newborns per litter, the weights of the fetuses and offspring were analysed using the Student's t-test. The incidence of postimplantation loss, skeletal and internal variations, delayed ossification, the live birth index, the survival rate of offspring and sex ratio of live fetuses were analysed non-parametricallly using the Wilcoxon's rank sum test, the chi-square test with Yates' correction or Fischer's exact probability test. In all cases, P<0.05 was chosen as the level of significance.
- Indices:
- Percent of intrauterine death: (No. of resorptions and dead foetuses/No. of implantation) x 100
Live birth index (%): (No. of live newborns at birth / No. of implantation remnants) x 100
Survival rate (%): (No. of live offspring on indicated day after birth / No. of offspring at birth) x 100 - Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - 5 % group: significantly (p<0.05) decreased body weight gain
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- - 5 % group: food intake of the pregnant rats was low when compared to the control group (day 9 - 20; p < 0.05; -26 %).
- 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:
- - neither mortality nor clinical signs of toxicity were observed in any group.
- 0.32, and 0.63 % groups: food intake of the pregnant rats was low when compared to the control group (p < 0.05).
- no differences between the control and other sodium sulfite-treated groups were observed.
Observation in groups of dams (0.32%, 5% and control) that were allowed to deliver and rear their offspring
- maternal body weight gain three weeks after delivery was not significantly affected by treatment during GD 8-20.
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- - at sacrifice on day 20 of pregnancy, the reproductive parameters obtained such as the numbers of implants, live foetuses and intrauterine death (resorptions and dead foetuses) were found not significantly different between the control and sodium sulfite-treated groups.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Remarks on result:
- other: The NOAEL for maternal toxicity can be established at 2.5% in the diet (approx. 1750 mg/kg bw/d Na2SO3 x 7 H2O, approx. 850 mg/kg bw/d Na2SO3 or approx. 440 mg/kg bw/d as SO2 equivalents).
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- - foetal body weights in all of the sodium sulfite-treated groups except 2.5 % group (females only) were significantly lower than in the control group (p < 0.05).
- 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:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Observation at day 20 of pregnancy (0.32-5% and control):
- at sacrifice on day 20 of pregnancy, the sex ratios of foetuses were found not significantly different between the control and test item-treated groups.
Fetal examinations:
- External, skeletal and internal malformations of the foetuses were not observed at any dose level.
- several types of foetal skeletal variations such as lumbar ribs, hypoplastic rib and delayed ossifications were observed in the test item-treated groups, except for the 1.25 % group. The differences were found not significant in comparison with the control group.
- degree of delayed ossification was slightly, but not significantly increased by high doses of the test item.
- few foetuses with dilatation of the renal pelvis (reduction of renal papilla) and lateral ventricle were observed, but there was no significant dose-dependence.
Observation in groups of dams (0.32%, 5% and control) that were allowed to deliver and rear their offspring
- The live birth index and survival rate (day 7 and 28) of offspring was not affected by treatment.
- Pup body weight gain at 3 weeks after birth were not affected by the sodium sulfite-treatment.
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
- Remarks on result:
- other: Some evidence of growth retardation was observed in all groups at & above a dietary dose of 0.32% (approx. 200 mg/kg bw/d Na2SO3 x 7 H2O, approx. 100 mg/kg bw/d Na2SO3); no dose-relationship was seen. Effects were not observed in the live-birth part.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Treatment of pregnant Wistar rats with diets containing 0, 0.32, 0.63, 1.25, 2.5 and 5% Na2SO3 * 7H2O in the diet from GD 8 to GD 20 resulted in effects on body weight gain and food consumption at 5%, but no clinical signs of toxicity were recorded. Some evidence of growth retardation was observed in all treatment groups, but there was no dose-relationship and these effects were not observed in the live-birth part of the study, which was indicated by a lack of changes in male and female pups 3 weeks after birth. These effects were considered as might be related to maternal malnutrition and/or disturbance in metabolism by liberated sulfur dioxide. No evidence of teratogenicity was seen in the study.
Thus, the NOAEL for maternal toxicity can be established at 2.5% in the diet (approx. 1750 mg/kg bw/d Na2SO3 x 7 H2O, approx. 850 mg/kg bw/d Na2SO3 or approx. 440 mg/kg bw/d as SO2 equivalents). There was no clear evidence for foetal toxicity, but slight fetal growth retardation was observed at dietary doses at and above 0.32% (approx. 200 mg/kg bw/d Na2SO3 x 7 H2O, approx. 200 mg/kg bw/d or approx. 50 mg/kg bw/d as SO2 equivalents).
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