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EC number: 204-886-1 | CAS number: 128-44-9
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Van Went-De Vries and Kragten
- Year:
- 1 975
- Bibliographic source:
- Fd Cosmetic. Toxicol
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vivo chromosome aberration assay was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- other: In vivo chromosome aberration assay
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- EC Number:
- 204-886-1
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Cas Number:
- 128-44-9
- Molecular formula:
- C7H5NO3S.Na
- IUPAC Name:
- sodium 1,1,3-trioxo-2,3-dihydro-1H-1λ⁶,2-benzothiazol-2-ide
- Details on test material:
- - Name of test material: Saccharin sodium
- Molecular formula: C7H4NO3S.Na
- Molecular weight: 205.169 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): The saccharin contained six or seven impurities, the most important of which (comprising 0.5% of the material) was identified as o-toluenesulphonamide. The other impurities have not yet been identified.
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 2-3 months
- Weight at study initiation: 20 g
- Assigned to test groups randomly: [no/yes, under following basis: ] No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The test chemical was soluble in water
- Concentration of test material in vehicle: 0 or 1.5 mg/Kg bw/day
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on exposure:
- For oral route
PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in water to give a dose level of 0 or 1.5 mg/Kg bw/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data - Duration of treatment / exposure:
- Duration of exposure: 3 days
Duration of treatment: 8 days - Frequency of treatment:
- 3 days
- Post exposure period:
- 5 days
Doses / concentrations
- Remarks:
- 0 or 1.5 mg/Kg bw/day
- No. of animals per sex per dose:
- Total: 40
0 mg/Kg bw/day: 20
1.5 mg/kg bw/day: 20 - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The absence of data on the acute toxicity of saccharin in the Chinese hamster, an LD50 equal to that in the mouse was assumed, and on this basis the dose level chosen was relatively high being 10% of the LD50 for the mouse.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
DETAILS OF SLIDE PREPARATION: No data
METHOD OF ANALYSIS: Bone-marrow cultures were taken on day 8 after the pertussis injection, a PHA injection having been given on day 6. In every culture, 50 metaphases were analysed. Selection of mitoses occurred with a low-power objective (x 10). No numerical or structural abnormalities can be seen at this magnification. The total numbers of aneuploidy cells, polyploid cells and structural abnormalities were noted in every culture with a high-power oil-immersion objective. The number of polyploid cells was related to the total number of mitoses observed in the course of selection of the 50 metaphases for analysis. The total number of breaks was expressed in terms of the minimal number of breaks necessary for the formation of the total number of structural abnormalities in 50 metaphases.
OTHER: No data - Evaluation criteria:
- The total numbers of aneuploidy cells, polyploid cells and structural abnormalities were noted
- Statistics:
- It was assumed that the observed frequencies would follow approximately a Poisson distribution. In order to obtain a normal distribution, the data were transformed according to the transformation of Freeman and Tukey. A student’s t test was applied to the transformed data. Because we were not interested in the possible decrease in chromosome aberrations by saccharin, only the probability of an increase in abnormalities by chance was tested. For this reason a one tailed test was used.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic potential
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: No data
- Solubility: No data
- Clinical signs of toxicity in test animals: No data
- Evidence of cytotoxicity in tissue analyzed: No data
- Rationale for exposure: No data
- Harvest times: No data
- High dose with and without activation: No data
- Other: No data
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data
- Induction of micronuclei (for Micronucleus assay): No data
- Ratio of PCE/NCE (for Micronucleus assay): No data
- Appropriateness of dose levels and route: No data
- Statistical evaluation: No statistically significant differences were found between the control and treated groups.
Any other information on results incl. tables
Table: Number of polyploidy cells on 50 metaphases in the bone marrow of control and the test chemical treated Chinese hamsters
Polyploid cells* |
No. of hamsters |
||
X |
Y |
Controls |
Saccharin treated |
0 |
1 |
4 |
5 |
1 |
2.41 |
4 |
2 |
2 |
3.15 |
4 |
3 |
3 |
3.73 |
4 |
3 |
4 |
4.24 |
4 |
1 |
5 |
4.69 |
0 |
2 |
6 |
5.10 |
0 |
1 |
7 |
5.47 |
0 |
1 |
8 |
5.83 |
0 |
1 |
12 |
7.07 |
0 |
1 |
X: number found
Y: transformed values
The differences between the number of controls and treated hamsters with any given number of polyploidy cells were not significant: t: 0.9830 (38df); 0.10<PR<0.25
Table: Number of anueploid cells on 50 metaphases in the bone marrow of control and treated Chinese hamsters
Anueploid cells* |
No. of hamsters |
||
X |
Y |
Controls |
Saccharin treated |
0 |
1 |
7 |
6 |
1 |
2.41 |
4 |
1 |
2 |
3.15 |
4 |
3 |
3 |
3.73 |
2 |
3 |
4 |
4.24 |
3 |
3 |
5 |
4.69 |
0 |
4 |
X: number found
Y: transformed values
The differences between the number of controls and treated hamsters with any given number of anueploid cells were not significant: t: 1.2797 (38df); 0.10<PR<0.25
Table: Number of structural chromosome abnormalities in 50 metaphases in the bone marrow of control and treated Chinese hamsters
Structural abnormalities* |
No. of hamsters |
||
X |
Y |
Controls |
Saccharin treated |
0 |
1 |
6 |
7 |
1 |
2.41 |
3 |
7 |
2 |
3.15 |
8 |
3 |
3 |
3.73 |
0 |
2 |
4 |
4.24 |
1 |
1 |
5 |
4.69 |
2 |
0 |
X: number found
Y: transformed values
The differences between the number of controls and treated hamsters with any given number of structural chromosome abnormalities were not significant: t: 0.9576 (38df); PR<0.75
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not induce a statistical significant increase in the chromosome aberrations between the control and treated group and hence the test chemical is not likely to classify as a gene mutant in vivo.
- Executive summary:
In vivo chromosome aberration assay was performed to determine the mutagenic nature of the test chemical. Chinese hamsters were treated with the test chemical at dose levels of 0 or 1.5 mg/Kg bw/day. Water was used as control. Animals in both groups were given an ip injection of pertussis vaccine, each animal receiving 0.25 ml of a suspension containing 16 x 109bacteria/ml. On days 2, 3 and 4 after the pertussis injection, water or saccharin dissolved in water was administered by gastric intubation to animals of the control and test group, respectively. Bone-marrow cultures were taken on day 8 after the pertussis injection, a PHA injection having been given on day 6. In every culture, 50 metaphases were analysed. Selection of mitoses occurred with a low-power objective (x 10). No numerical or structural abnormalities can be seen at this magnification. The total numbers of aneuploidy cells, polyploid cells and structural abnormalities were noted in every culture with a high-power oil-immersion objective. The number of polyploid cells was related to the total number of mitoses observed in the course of selection of the 50 metaphases for analysis. The total number of breaks was expressed in terms of the minimal number of breaks necessary for the formation of the total number of structural abnormalities in 50 metaphases. The test chemical did not induce a statistical significant increase in thechromosome aberrations between the control and treated group and hence the test chemical is not likely to classify as a gene mutant in vivo.
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