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EC number: 231-900-3 | CAS number: 7778-18-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 10101-41-4
- Cas Number:
- 10101-41-4
- IUPAC Name:
- 10101-41-4
- Reference substance name:
- calcium sulfate, dihydrate
- IUPAC Name:
- calcium sulfate, dihydrate
- Details on test material:
- - Name of test material (as cited in study report): Calcium sulfate, dihydrate
- Analytical purity: 99.9%
- Lot/batch No.: Sigma Aldrich LOT no. - 109H0166
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Calcium sulfate, dihydrate was dissolved in 1 % CMC (Sodium carboxymethyl Cellulose) and supersonic wave was used to prepare the highest dose concentration.
- Duration of treatment / exposure:
- 1 day
- Frequency of treatment:
- Single treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw/day
- Dose / conc.:
- 2 500 mg/kg bw/day
- Dose / conc.:
- 5 000 mg/kg bw/day
- No. of animals per sex per dose:
- 6
- Positive control(s):
- - mitomycin C
- Doses / concentrations: 0.5 mg/kg and 1.0 mg/kg
Examinations
- Details of tissue and slide preparation:
- To observe the cell multiplication of bone marrow, a specimen was fixed with methanol. And 4 % Giemsa solution was used for dyeing to observe the ratio of polychromatic erythrocytes. To observe the micronucleus in the polychromatic erythrocytes, 40 μg/ml acridine was dropped for dyeing
- Evaluation criteria:
- At least 2000 polychromatic erythrocytes per animal were scored for the incidence of micronuclei
- Statistics:
- ANOVA (using Sigmastat 2.0 statistic programme)
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks on result:
- other: Calcium sulfate dihydrate showed negative results in the micronucleus test in vivo up to the test concentration of 5000 mg/kg b.w
Any other information on results incl. tables
Table 1: Effect on mitotic index or PCE/NCE ratio by dose level.
Dose (mg/kg) |
Group mean (PCE/(PCE+NCE)) (%) |
Group mean frequency of MNPCE (per 1,000) |
Vehicle 1,250 2,500 5,000 Positive control (0.5mg/kg) Positive control (1.0mg/kg) |
60.49±7.77 56.58±9.07 54.61±6.13 54.48±9.02 46.58±10.76 46.96±7.08 |
6.5 7.0 7.7 8.0 19.2 44.8 |
Applicant's summary and conclusion
- Conclusions:
- negative
Calcium sulfate dihydrate showed negative results in the micronucleus test in vivo up to the test concentration of 5000 mg/kg b.w
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