Tricobalt dicitrate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Micronucleus test and erythropoiesis: Effect of cobalt on the induction of micronuclei by mutagens.

Author:

Suzuki, Y. et al.

Year:

1993

Bibliographic source:

Environmental and molecular mutagenesis 22: 101-106

Materials and methods

Principles of method if other than guideline:

CoCl2*6H2O was administered once by intraperitoneal injection to male mice. The test item was investigated for its ability to induce micronuclei in bone marrow cells.

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

7791-13-1

EC Number:

616-574-6

Cas Number:

7791-13-1

IUPAC Name:

7791-13-1

Constituent 2

Reference substance name:

cobalt(II) dichloride hexahydrate

IUPAC Name:

cobalt(II) dichloride hexahydrate

Details on test material:

- Name of test material (as cited in study report): cobalt(II)chloride hexahydrate
- Molecular formula (if other than submission substance): CoCl2*6H2O
- Molecular weight (if other than submission substance): 238 g/mol
- Analytical purity: no data

Test animals

Species:

mouse

Strain:

other: BALB/c AnNCrj

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 22-27 g
- Diet (e.g. ad libitum): CRF-1 diet supplied by Charles River Japan, ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: water

Duration of treatment / exposure:

one injection

Frequency of treatment:

one injection

Post exposure period:

30 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 50, 90 mg/kg bw
Basis:
analytical conc.

No. of animals per sex per dose:

5 male animals per dose

Control animals:

yes

Positive control(s):

none

Examinations

Tissues and cell types examined:

bone marrow cells

Statistics:

The data for micronucleus induction were analysed statistically by the Kastenbaum-Bowman method [Kastenbaum and Bowman, 1970]. Data for the P/N ratio were analysed statistically using student´s t-test and one-way layout analysis of variance.

Results and discussion

Test results

Sex:

male

Genotoxicity:

positive

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Any other information on results incl. tables

Treatment with the test item induced a dose-dependent increase in MPCE frequency. The P/N ratio was the lowest at 90 mg/kg bw of CoCl2*6H2O in the in vivo micronucleus test.

Dose of CoCl2*6H2O [mg/kg bw]	MPCE frequency [%]	P/N ratio
90	0.75±0.43**	0.87±0.19**
50	0.46±0.09**	1.44±0.44
25	0.12±0.13	2.47±0.17
0	0.18±0.15	1.98±0.32

Results show mean ± SD

** P < 0.05 statistically different from the solvent control

Doses of CoC6H6O7:

26.2, 52.3 and 94.2 mg/kg bw CoC6H6O7 (recalculated values, equivalent to 25, 50 and 90 mg/kg bw CoCl2*6H2O)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): positive