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EC number: 217-157-8 | CAS number: 1758-73-2
- 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 somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Reference Type:
- secondary source
- Title:
- Methanesulfinic acid, Aminoimino, CAS No: 1758-73-2
- Author:
- OECD SIDS
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS; UNEP Publications
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adapted in 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted un 1992
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Hessisches Ministerium für Umwelt, Energie und Bundesangelegenheiten
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Aminoiminomethanesulphinic acid
- EC Number:
- 217-157-8
- EC Name:
- Aminoiminomethanesulphinic acid
- Cas Number:
- 1758-73-2
- Molecular formula:
- CH4N2O2S
- IUPAC Name:
- aminoiminomethanesulphinic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Füllinsdorf, Germany
- Age at study initiation: approx. 8 – 12 weeks
- Weight at study initiation: 30.4 ± 15.5 g (males); 25.6 ± 1.2 (females)
- Fasting period before study: approx. 18 h
- Housing: individual in Macrolon cages Type I, with wire mesh top, and granulated soft wood bedding
- Diet: pelleted standard diet (Altromin 1324), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used:distilled water
- Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24, 48, and 72 h after treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 30 mg cyclophosphamide/kg bw
cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 30 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Range finding study to find the maximum tolerated dose level
TREATMENT AND SAMPLING TIMES: the animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged for 10 min and the supernatant was discarded. A small drop of the suspended pellet was spread on a slide.
DETAILS OF SLIDE PREPARATION: slides were stained with May-Grünwald/Giemsa-solution
METHOD OF ANALYSIS: evaluation of the slides was performed using NIKON microscopes with 100 x immersion oil objectives. 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in normochromatic erythrocytes per 1000 PCEs. The analysis was performed with coded slides. - Evaluation criteria:
- The test item is classified as mutagenic if it induces a statistically significant increase in the number of micronucleated polychromatic erythrocytes for at least one of the test points.
A test item producing no statistically significant increase in the number of micronucleated polychromatic erythrocytes at any of the test points is considered non-mutagenic under the test conditions.
However, both biological and statistical significance should be considered together. - Statistics:
- Non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 600 – 1200 mg/kg bw
- Clinical signs of toxicity in test animals: 1200 mg/kg bw: reduction of spontaneous activity, was observed in 2/2 males and 2/2 females at 1, 6, 24, and 48 h after exposure and in 1/2 males and 1/2 females at 72 after exposure. Eyelid closure: was observed in 2/2 males and 1/2 females, at 1, 6, and 24 h and in 1/2 males and female at 48 h post-exposure. Apathy was observed in 2/2 males and 1/2 males at 1 and 24 h after exposure, in 2/2 males and females 6 h after exposure and in 1/2 male and females at 48 h after exposure.
RESULTS OF DEFINITIVE STUDY
The mean number of normochromatic erythrocytes was not increased after treatment with formamidine sulfinic acid as compared to the mean values of NCEs of the negative control, indicating that formamidine sulfinic acid had no cytotoxic properties in the bone marrow. There was no enhancement in the frequency of the detected micronuclei in comparison to the negative control at any preparation interval after administration of formamidine sulfinic acid. 30 mg/kg bw cyclophosphamide administered per os was used as positive control which showed a statistically significant increase of induced micronucleus frequency.
Any other information on results incl. tables
Table 1. Micronuclei in polychormatic erytrhrocytes (PCE) and relationship PCE/NCE (NCE= normochromatic erythrocytes)
Dosemg/kg bw |
Sampling time |
PCEs withMicronulei |
Range |
PCE/NCE |
0 |
24 h |
0.14 % |
0 - 4 |
1000/880 |
600 |
24 h |
0.12 % |
0 - 3 |
1000/881 |
600 |
48 h |
0.11 % |
0 - 3 |
1000/889 |
600 |
72 h |
0.11 % |
0 – 3 |
1000/839 |
Cyclophohamide, 30 |
72 h |
0.11% |
0 - 3 |
1000/941 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
During the study described and under the experimental conditions reported, formamidine sulfinic acid did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore, formamidine sulfinic acid is considered to be non-mutagenic in this micronucleus assay.
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