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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.