[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Toxicological studies on malachite green: A triphenylmethane dye

Author:

Clemmensen S., Jensen C., Jensen N., Meyer O., Olsen P., Wurtzen G.

Year:

1984

Bibliographic source:

Arch Toxico l1984) 56: 43-45

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Malachite Green Oxalate

IUPAC Name:

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

Species:

mouse

Strain:

NMRI

Sex:

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

Remarks:

Doses / Concentrations:
37.5 mg/kg
Basis:
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

Examinations

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

Conclusions:

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.