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EC number: 606-834-7 | CAS number: 21806-61-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to OECD 474; read-across data
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 1,3-propanesultone
- EC Number:
- 214-317-9
- EC Name:
- 1,3-propanesultone
- Cas Number:
- 1120-71-4
- Molecular formula:
- C3H6O3S
- IUPAC Name:
- 1,2-oxathiolane 2,2-dioxide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Wako Pure Chemical Industries, Ltd., Osaka, Japan; WDM4950
- Purity: >97%
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Mice were given commercial pellets and water ad libitum throughout the acclimatization and experimental periods.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Saline
- Duration of treatment / exposure:
- 2 IP injections, 24 hrs apart
- Frequency of treatment:
- Twice (24 hrs apart)
- Post exposure period:
- 24, 48, 72 hrs
Doses / concentrationsopen allclose all
- Dose / conc.:
- 9 mg/kg bw/day (nominal)
- Dose / conc.:
- 18 mg/kg bw/day (nominal)
- Dose / conc.:
- 36 mg/kg bw/day (nominal)
- Dose / conc.:
- 72 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6 males
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- - Mitomycin C
- Justification for choice of positive control(s):
- Route of administration: single IP injection; sampled at 48 hrs
- Doses / concentrations: 0.5 mg/kg
Examinations
- Tissues and cell types examined:
- Peripheral blood reticulocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The highest dose was fixed by the preliminary dose-finding test, and the micronucleus assay was performed at three levels – the highest dose and 1/2 and 1/ 4 of the highest dose. The highest dose was based on mortality.
METHOD OF ANALYSIS: Micronucleated polychromatic erythrocyte and micronucleated reticulocyte frequencies were based on the observation of at least 1000 polychromatic erythrocytes or reticulocytes per animal.
- Evaluation criteria:
- An expert committee evaluated each chemical considering the judgement by the investigators who performed the experiment, p-values, reproducibility, magnitude of response and biological significance. Although biological significance is difficult to judge, we took into account dose-response relationships, the kinetics of micronucleus appearance, the historical control levels when available, and the absolute magnitude of the response.
- Statistics:
- Pair-wise comparisons were made between the 0 hr sampling data and later sampling data. When the control data were acceptable, the increase in micronucleus frequency against the concurrent negative control data was evaluated using a conditional binomial test and the dose-response relationship was evaluated using the Cochran-Armitage trend test. When these were both significant, the data was declared positive. If neither step showed significance, the data was judged negative. All other cases were called inconclusive.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Remarks:
- LD50 (MTD) = 290 mg/kg bw
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): There was a statistically significant increase (p<0.05) in micronucleated cells treated with 36 and 72 mg/kg bw 1,3-Propanesultone at 24, 48 and 72 hrs (Table 1)
- Statistical evaluation: The results of the Cochran-Armitage trend tests were all 0.000.
Any other information on results incl. tables
Table 1: Micronucleus assay results
% of MNPCE or MNRET (after the final treatment) |
|||||||
|
|||||||
Dose |
0 h |
24 h |
48 h |
72 h |
|||
mg/kg bw |
mean±SD |
mean±SD |
p |
mean±SD |
p |
mean±SD |
p |
|
|
|
|
|
|
|
|
9 |
0.08± 0.04
|
0.17± 0.10
|
0.151
|
0.10± 0.13
|
0.500
|
0.08± 0.10
|
0.623
|
18 |
0.10± 0.11
|
0.23± 0.10
|
0.058 |
0.10± 0.11
|
0.613 |
0.07± 0.05
|
0.828 |
36 |
0.12± 0.08
|
0.87± 0.53
|
0.000 |
0.63± 0.16
|
0.000 |
0.28± 0.16
|
0.032 |
72 |
0.10± 0.09
|
1.92± 0.99
|
0.000 |
1.68± 0.50
|
0.000 |
0.27± 0.14
|
0.026 |
p = value of pairwise comparisons. The results of the Cochran-Armitage trend tests were all 0.000.
Applicant's summary and conclusion
- Conclusions:
- In an in vivo micronucleus assay in male CD-1 mice, there was a statistically significant increase in micronucleated cells treated with 36 and 72 mg/kg bw 1,3-Propanesultone at 24, 48 and 72 hrs.
- Executive summary:
In a CD-1 mouse peripheral blood micronucleus assay (Morita et al., 1997), groups of 6 male mice were treated by IP injection with 1,3-Propanesultone (>97%) in saline at doses of 9, 18, 36 and 72 mg/kg bw/day. A peripheral blood sample was taken from each animal immediately before treatment (0 hrs; control) and then the animals were dosed twice (0, 24 hrs) and peripheral blood was sampled at 24, 48 and 72 hrs. The positive control was Mitomycin C (0.50 mg/kg bw). Micronucleated polychromatic erythrocyte and micronucleated reticulocyte frequencies were based on the observation of at least 1000 polychromatic erythrocytes or reticulocytes per animal.
There was a statistically significant increase (p<0.05) in micronucleated cells treated with 36 and 72 mg/kg bw 1,3-Propanesultone at 24, 48 and 72 hrs. The results of the Cochran-Armitage trend tests were all 0.000. Therefore, 1,3-Propanesultone induced micronucleated reticulocytes in male CD-1 mice by double intraperitoneal treatments starting at relatively low doses.
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