Calcium sulfate

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:

2002

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

Test material information

Constituent 1

Reference substance name:

10101-41-4

Cas Number:

10101-41-4

IUPAC Name:

10101-41-4

Constituent 2

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

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 / concentrations

Doses / concentrations 1

Dose / conc.:

1 250 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

2 500 mg/kg bw/day

Doses / concentrations 3

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