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Toxicological information

Genetic toxicity: in vivo

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Administrative data

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not GLP study, not good described. Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
Toxicological studies on malachite green: A triphenylmethane dye
Clemmensen S., Jensen C., Jensen N., Meyer O., Olsen P., Wurtzen G.
Bibliographic source:
Arch Toxico l1984) 56: 43-45

Materials and methods

Test guideline
according to guideline
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Malachite Green Oxalate
Malachite Green Oxalate
Details on test material:
- Name of test material: Malachite Green Oxalate
- Source: Dansk Orredforder A/S, Brande, Danmark
- Structure: (C23H25N)2 (COO)2 X 2 (COOH)2
- Analytical purity: > 90% detected by TLC

Test animals

not specified
Details on test animals or test system and environmental conditions:
- Source: G1. Bomholtgard, Ry, Denmark

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
Single exposure
Frequency of treatment:
Single exposure
Doses / concentrations
Doses / Concentrations:
37.5 mg/kg
nominal in diet
No. of animals per sex per dose:
5 animals
Control animals:
yes, concurrent vehicle
Positive control(s):
50 mg cyclophosphamide/kg bw


Tissues and cell types examined:
Animals were killed at 24, 42 and 66 hours after dosing. Bone marrow smears were prepared from each animals and stained with May-Grunwald/Giemsa. One thousand polychromatic erythrocytes were counted.

Results and discussion

Any other information on results incl. tables

After a single exposure of 37.5 mg/kg bw, 0.07, 0.13 and 0.11% micronuclei were counted at sampling times 24, 42, 66 hours while the percent of micronuclei in the positive control was 1.55, 2.03 and 0.70 and in negative control 0.16%

Applicant's summary and conclusion

Interpretation of results (migrated information): negative
No clastogenic effects were demonstrated in this micronucleus test
Executive summary:

The micronuclei test on mice was carried out to determine the potential chromosome damaging effect. Groups of five animals were given the maximum tolerated dose (37.5 mg/kg) by garage.

No significant increase in the number of micronuclei was found in any of the treated groups. After a single exposure of 37.5 mg/kg body weight, 0.07, 0.13, and 0.11% micronuciei were counted at sampling times 24, 42, or 66 h while the per cent of micronuclei in the positive control was 1.55, 2.03, and 0.70 and in the negative control (distilled water) 0.16%.

No clastogenic effects were demonstrated in this micronucleus test.