Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo insect germ cell study: gene mutation
Remarks:
Drosophila SLRL test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Comparative mutagenicity of two triarylmethane food dyes in salmonella, saccharomyces and drosophila
Author:
D. S. ANGUS, R. S. U. BAKER and A. M. BONIN, D. CALLEN and A. M. CLARK
Year:
1981
Bibliographic source:
Food and cosmetics toxicology, Vol.19. pp. 419 to 424. 1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
In- vivo gene mutation assay was performed for the test chemical Lissamine Green B in Canton-S Drosophila by the injection route of exposure
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula :C27H26N2O7S2.Na
- Molecular weight: 576.623 g/mol
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- Name of the test material: Lissamine Green B
- EC name: Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula: C27H26N2O7S2.Na
- Molecular Weight: 576.623 g/mol
- Substance type: Organic
- Smiles: c12c(\C(c3ccc(N(C)C)cc3)=C3/C=C\C(=[N+](/C)C)C=C3)c(O)c(S(=O)(=O)[O-])cc1cc(S(=O)(=O)[O-])cc2.[Na+]
- Purity: 89%

Test animals

Species:
Drosophila melanogaster
Strain:
other: Canton S
Details on species / strain selection:
No data
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data available
- Age at study initiation: 4-7 day old
- Weight at study initiation: No data available
- Assigned to test groups randomly: [no/yes, under following basis: ] No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
other: Injection
Vehicle:
- Vehicle(s)/solvent(s) used: 0.7% NaCl
- Justification for choice of solvent/vehicle: The chemical was soluble in 0.7% NaCl
- Concentration of test material in vehicle: 0.0025 or 0.025 M
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Lissamine B was dissolved in 0.7% NaCl to give a dose level of 0.0025 or 0.025 M.

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
Duration of treatment / exposure:
72 hrs
Frequency of treatment:
Continuous for 72 hrs
Post exposure period:
No data
Doses / concentrations
Remarks:
0.0025 or 0.025 M
No. of animals per sex per dose:
Total: 48
12 males and 36 females (three females for each male)
Control animals:
not specified
Positive control(s):
Ethylmethane sulphonate (EMS)
- Justification for choice of positive control(s): No data
- Route of administration: Oral
- Doses / concentrations: Positive control adults were fed 0.025 M-ethyl methane sulphonate (EMS) and third instar larvae were fed on a yeasted suspension containing 0.0025 M-EMS.

Examinations

Tissues and cell types examined:
Brood progenies were observed for recessive lethal mutations
Details of tissue and slide preparation:
No data
Evaluation criteria:
An increase in the frequency of sex-linked recessive lethal mutations
Statistics:
No data

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Lissamine Green B failed to induce sex linked recessive lethal mutation in Canton S Drosophila melanogaster and hence is considered to be negative for gene mutation in vivo.
Executive summary:

In vivo gene mutation assay was performed for the test chemical Lissamine Green B in male Canton-S Drosophila melanogaster by the injection route. Adult male flies were injected with dye in 0.7% NaCl solution at a dose level of 0.0025 or 0.025 M . Alternatively Drosophila larval stages were reared on standard semolina-treacle-agar culture medium containing dye. The positive control for these experiments was ethylmethane sulphonate (EMS), adults having been fed for 72 hr and third instar larvae for 48 hr on a yeasted suspension containing EMS. The frequency of sex-linked recessive lethal mutations in Drosophila melanogaster was estimated by the Basc method. Mutants were scored by mating 12 treated 4-7 day old Canton-S males to Basc females, three females for each male. with successive broods from fresh virgin females at 72-hr intervals. All cultures were maintained at 25 deg C and suspected lethals were checked in the F3 generation. No evidence of recessive lethal mutations was found among the first brood progeny of either adults (0/240) or larvae (0/94) treated with Lissamine Green B and hence it is considered to be negative for gene mutation in vivo.