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EC number: 233-135-0 | CAS number: 10043-01-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- Tested by KRICT, Korea.,(Test No. G01100),
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Calcium sulfate, dihydrate
- IUPAC Name:
- Calcium sulfate, dihydrate
- Reference substance name:
- 10101-41-4
- EC Number:
- 600-148-1
- Cas Number:
- 10101-41-4
- IUPAC Name:
- 10101-41-4
- Details on test material:
- - Name of test material: Calcium sulfate, dihydrate
- Molecular formula (if other than submission substance): CaSO4•2H2O
- Molecular weight (if other than submission substance): 172.171
- Smiles notation (if other than submission substance): O.O.[O-]S(=O)(=O)[O-].[Ca+2]
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Density -2.32 g/cm3)
- Solubility in water - 2.05 g/L at 20 °C
- Synonyms: Alabaster
Annaline
C.I. Pigment white 25
Gypsum
Gypsum stone
Land and plaster
Light spar
Magnesia white
Mineral white
Native calcium sulfate
Precipitated calcium sulfate
Sainite
Satin spar
Sulfuric acid, calcium(2+) salt, dihydrate
Terra alba
- Calcium sulfate, dihydrate consists of colorless, monoclinic and hygroscopic crystals
Constituent 1
Constituent 2
Method
- Target gene:
- Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and Escherichia coli WP2 uvrA
The direct incorporation method: For test without metabolic activation, the test substance and 0.1 ml of fresh bacterial culture were added to
2.0 ml of overlay agar. For tests with metabolic activation, 0.5 ml of metabolic activation mixture containing an adequate amount of postmitochondrial
fraction was added to the overlay agar after the addition of the bacteria and test substance. All plates in a given test should be incubated for the
same time period.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 12, 37, 111, 333, 1,000 and 3,000 ug/plate
- Vehicle / solvent:
- Solvent: sterile distilled water
Description of follow up repeated study: Preliminary test had carried out to decide the appropriate starting dose level of the main study at the
concentration of 1.6, 8, 40, 200, 1,000 and 3,000 μg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- sterile distilled water
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene with S9, Sodium azide, 4-nitroquinoline-1-oxide, 9-aminoacridine
- Details on test system and experimental conditions:
- Test condition :
Number of replicates: one
Frequency of dosing: 2 plates/dose
Positive and negative control groups and treatment: Negative control solvent
control (sterile distilled water), positive control: 2-aminoanthracene with S9, Sodium azide, 4-nitroquinoline-1-oxide, 9-aminoacridine
Number of metaphases analyzed: Not analyzed
Solvent: sterile distilled water
Description of follow up repeated study: Preliminary test had carried out to decide the appropriate starting dose level of the main study at the
concentration of 1.6, 8, 40, 200, 1,000 and 3,000 μg/plate.
Criteria for evaluating results: the number of revertant colonies in the plate was counted after 2 days incubation at 37 °C.
The direct incorporation method: For test without metabolic activation, the test substance and 0.1 ml of fresh bacterial culture were added to
2.0 ml of overlay agar. For tests with metabolic activation, 0.5 ml of metabolic activation mixture containing an adequate amount of postmitochondrial
fraction was added to the overlay agar after the addition of the bacteria and test substance. All plates in a given test should be
incubated for the same time period. - Evaluation criteria:
- Criteria for evaluating results: the number of revertant colonies in the plate was counted after 2 days incubation at 37 °C.
The direct incorporation method: For test without metabolic activation, the test substance and 0.1 ml of fresh bacterial culture were added to
2.0 ml of overlay agar. For tests with metabolic activation, 0.5 ml of metabolic activation mixture containing an adequate amount of postmitochondrial
fraction was added to the overlay agar after the addition of the bacteria and test substance. All plates in a given test should be
incubated for the same time period.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: With metabolic activation: not observed. Without metabolic activation: not observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: With metabolic activation: not observed. Without metabolic activation: not observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Results
Cytotoxicity conc: With metabolic activation: not observed
Without metabolic activation: not observed
Genotoxic effects: With metabolic activation: negative
Without metabolic activation: negative - Remarks on result:
- other: strain/cell type: Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RS-Freetext:
Result of bacterial reverse mutation assay with calcium sulfate, dihydrate
Colonies/plate (mean)[Factor]
Tester Chemical Dose Without S-9 mix With S-9mix
strain treated (mg/plate)
TA100 Test item 0 132 114
12 139 [1.0] 115 [1.0]
37 143 [1.1] 122 [1.1]
111 125 [0.9] 115 [1.0]
333 129 [1.0] 125 [1.0]
1,000 124 [0.9] 106 [1.0]
3,000 124 [0.9] 115 [1.0]
TA1535 Test item 0 13 10
12 20 [1.5] 11 [1.1]
37 22 [1.7] 12 [1.2]
111 17 [1.3] 13 [1.3]
333 16 [1.2] 14 [1.4]
1,000 17 [1.3] 13 [1.3]
3,000 14 [1.1] 9 [0.9]
TA98 Test item 0 22 34
12 22 [1.0] 28 [0.8]
37 21 [0.9] 26 [0.8]
111 29 [1.3] 37 [1.1]
333 25 [1.1] 31 [0.9]
1,000 23 [1.0] 33 [1.0]
3,000 22 [1.0] 36 [1.0]
TA1537 Test item 0 15 17
12 16 [1.0] 17 [1.0]
37 11 [0.7] 22 [1.3]
111 15 [1.0] 19 [1.1]
333 14 [0.9] 17 [1.0]
1,000 13 [0.9] 16 [0.9]
3,000 12 [0.8] 16 [0.9]
E.coli
WP2 uvrA Test item 0 8 12
12 7 [0.9] 8 [0.7]
37 6 [0.8] 13 [1.1]
111 8 [1.0] 8 [0.7]
333 8 [1.0] 8 [0.7]
1,000 6 [0.8] 9 [0.8]
3,000 6 [0.8] 9 [0.8]
Positive controls
TA100 SA 0.5 493 [3.7]
TA1535 SA 0.5 371 [28.5]
TA98 4NQO 0.5 426 [19.4]
TA1537 9-AA 50 740 [49.3]
WP2 uvrA 4NQO 0.5 377 [47.1]
TA100 2-AA 0.4 491 [4.3]
TA1535 2-AA 2 394 [39.4]
TA98 2-AA 0.4 14 [0.6] 289 [8.5]
TA1537 2-AA 2 326 [19.2]
WP2 uvrA 2-AA 4 311 [25.9]
[Factor]: No. of colonies of treated plate/No. of colonies of negative control plate
SA: Sodium azide
9-AA: 9-Amino acridine
4NQQ: 4-nitroquinoline-1-oxide
2-AA: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
CL-Freetext:
The mutation in the Salmonella tryphimurium (strains TA 98, TA 100, TA 1535, and TA 1537) and in the Escherchia coli WP2 uvrA did not occur with calcium sulfate, dihydrate
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