Aluminum magnesium vanadium oxide

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

(adopted July 1997)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide

EC Number:

692-448-4

Cas Number:

170621-28-0

Molecular formula:

Mg2xAl2xVyOz

IUPAC Name:

divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide

Test material form:

solid: particulate/powder

Details on test material:

light yellow

Test animals

Species:

mouse

Strain:

ICR

Details on species / strain selection:

A total of 36 male and 8 female Hsd:ICR(CD-1) mice were ordered and
supplied by Charles River Italy S.p.A., Calco (Lecco), Italy. All animals were
received in good health conditions. They were 5 to 6 weeks old at the time
of treatment. Females were only used for the preliminary toxicity test that
was carried out in order to select the dose levels to be used for the Main Assay.

Sex:

male

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RESULTS OF RANGE-FINDING STUDY
- Dose range: 1000 and 2000 mg/kg bw were tested
- Clinical signs of toxicity in test animals: all animals survived, no abnormalities detected
- Evidence of cytotoxicity in tissue analyzed: no evidence of bone marrow toxicity
- Harvest times: 24 hours after treatment


RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no
- Ratio of PCE/NCE (for Micronucleus assay):
- Appropriateness of dose levels and route:
- Statistical evaluation:

Any other information on results incl. tables

Table 1: Summary

Treatment	Dose level mg/kg bw/day	Incidence of micronucleated PCEs				PCEs/(PCEs+NCEs) % over the mean control value
		mean	SE	Range
				min	max
Vehicle	0	1.5	0.2	1.0	2.0	100
Test item	500	1.8	0.4	1.0	3.0	117
Test item	1000	0.8	0.2	0.0	1.0	100
Test item	2000	1.4	0.3	0.5	2.5	105
Mitomycin C	3.00	10.8***	1.6	6.0	16.0	94
PCE = polychromatic erythrocytes NCE = normochromatic erythrocytes *** = incidence significantly greater than control value at p < 0.001

Applicant's summary and conclusion

Conclusions:

It is concluded that, under the reported experimental conditions, aluminium magnesium vanadium oxide, administered by oral gavage, does not induce cytogenetic damage and/or disruption of the mitotic apparatus in mouse bone marrow, as measured by the induction of micronuclei in polychromatic erythrocytes.