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EC number: 231-548-0 | CAS number: 7631-90-5
- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Although the overall reporting quality fulfils the criteria for its use in the chemicals safety assessment, the method is of limited relevance (test guidance has been withdrawn and superseded by more up-to-date guidelines). Thus, the reference is considered reliable with restriction but only as supporting information in a weight of evidence assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a dominant lethal assay, the induction of dominant lethal mutations in rat after sodium bisulfite administration was investigated. Male Sprague-Dawley rats (53 to 62 days old, bodyweight 247-339 g) were given sodium bisulfite in diet, ad libitum at doses of 45, 15 and 4.5 mg/kg/day over a period of 10 weeks. Animals in the positive control group received triethylenemelamine (TEM). After the 10-week treatment period, 40 male rats from the vehicle control group and 20 male rats from each treatment group were selected and mated with two adult virgin females for seven days. These females were replaced with two new females for an additional 7-day mating period. Each female was sacrificed 15-19 days after the first day of cohabitation.
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Sodium hydrogensulfite
- EC Number:
- 231-548-0
- EC Name:
- Sodium hydrogensulfite
- Cas Number:
- 7631-90-5
- Molecular formula:
- NaHSO3
- IUPAC Name:
- sodium hydrogensulfite
- Test material form:
- solid: granular
- Details on test material:
- - Name of test material (as cited in study report): sodium bisulfite (76-72)(prepared by J.T. Baker Chemical Comany, Phillipsburg, New Jersey)
- Physical state: granular compound
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Gilroy, California
- Age at start of treatment: 53 to 62 days old
- Weight at start of treatment: between 247 and 339 g
- Housing: housed in shoebox cages with hardwood chip bedding. Males were housed three per cage during the treatment phase.
- Diet (ad libitum)
- Water (ad libitum)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): ground laboratory chow (finely Purina rat diet supplemented with 50 mg thiamine per kg of finished diet)
The compound was added to a finely ground commercial diet. Concentrations of compound in the diet were adjusted weekly to achieve the dose levels.
Individual body weight and food consumption were used to to calculate the concentration of compound to be mixed into each kilogram of diet to achieve the desired dose levels.
The test compound was incorporated into a ground laboratory chow on a weight-to-weight basis. To ensure adequate distribution in the diet, the compound was initially suspended in corn oil. The compound-corn oil mixture was then added to the diet. The final concentration of corn oil was 3% in all diet levels.
- Storage temperature of food: excess was stored at 4°C to minimize compound loss - Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- ad libitum
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 45 mg/kg bw/day (nominal)
- Dose / conc.:
- 4.43 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 14.76 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 44.23 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Treatment groups: 20 male rats
Positive control group: 20 male rats
Vehicle control group: 40 male rats - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylenemelamine (TEM)
- Route of administration: drinking water
- Doses / concentrations: approximately 0.04 mg/kg/day
The positive control group received the positive control substance, administered in the drinking water at a concentration of 0.60 mg/liter throughout the 10-week treatment period. Solutions were preapred fresh daily and the previous day's water was discarded. Based on the average rat weight of 369 g for the 10-week exposure period and an estimated intake of approximately 25 mL per rat per day, the average TEM dose was approximately 0.04 mg/kg/day.
Examinations
- Tissues and cell types examined:
- no data
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Before initiating the dominant lethal study of sodium bisulfite (76-72), the specific dosage information was reviewed.
METHOD:
After the 10-week treatment period, 40 male rats from the vehicle control group and 20 male rats from each experimental level (including the positive reference control group) were selected and housed individually. Each male was then mated with two adult virgin females (age: 70- to 94- days; weight: between 240 and 300 g) for seven days. These females were replaced with two new females for an additional seven-day mating period. Following mating, females were housed four per cage to await necropsy. Each female was sacrificed by carbon dioxide asphyxiation 15 to 19 days after the first day of cohabitation.
At sacrifice , the following data were collected and reported: number of pregnant females per number of mated females, number of total implants per pregnant female, number of live and dead implants per pregnant female, number of corpora lutea per pregnant female, number of females with one or more dead implants, and number of females with two or more dead implants. Deaths were classified as early or late.
In addition to the uterine evaluation, females were examined for the presence of intercurrent infections; infected animals were excluded from the study.
The following parameters were examined for an indication of a dominant lethal effect: total implants (live foetuses plus early and late deaths), total dead implants (early and late foetal deaths), live implants (total implants minus dead implants), dead implants per total implants, and preimplanatation loss (calculated as the difference between total corpora lutea and total implants). Total corpora lutea were also recorded, since a significant increase (or decrease) in this measure influences the statistical significance of the preimplantation loss.
The data on the proportion of females with one or more dead implants and the proportion with two or more dead implants were evaluated.
OBSERVATIONS:
All animals were observed daily for activity, health, behaviour, food and water intake, and mortality. Individual body weights of males were recorded initially and then weekly throughout the 10-week treatment period. During this phase, food consumption was also measured weekly by cage. - Evaluation criteria:
- no data
- Statistics:
- The t-test was applied to determine significant differences between the average number of live implantations per pregnant female at a dose level and the average for the control. A regression fit of the average number of live implantations was made for both the arithmetic and logarithmic dose to determine which was better. The data on dead implants per pregnant female were evvaluated by the t-test on Freeman-Tukey Square Root transformed data.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The dose of 76-72 received over the 10-week treatment period was greater than 98% of the intended dose for all three levels.
RESULTS OF DEFINITIVE STUDY
- body weight: body weight gains were comparable for control and treated groups -- 104, 108, and 97% of controls for the low, mid, and high dose levels. respectively. The TEM group gained significantly less than the vehicle control group.
- food consumption: values were within normal limits, with low- and mid-dose test groups comparable to the control group. High-dose animals consumed slightly less food each week and gained slightly less weight.
- water consumption: water intake were generally normal (treated animals did not differ from the controls).
- activity, physiological and behavioural responses: generally normal (treated animals did not differ from the controls).
- mortality: one high dose male died after 9 weeks of treatment.
- no females were found to have any intercurrent infections.
- the biological criteria used to evaluate mutagenic effects in the rat showed no consistent responses that could be attributed to treatment.
- statistical evaluation: there were occasional statistical differences between control and sodium bisulfite-treated groups, but they were generally random and did not suggest a time or dose-response effect.
- the positive reference control (TEM group showed significant effects during both weeks of breeding.
Applicant's summary and conclusion
- Conclusions:
- The dominant lethal test produced no consistent responses to suggest that sodium bisulfite is mutagenic to rats.
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