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EC number: 221-409-2 | CAS number: 3087-16-9
Genetic toxicity: in vivo
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:
- 1 981
- Bibliographic source:
- Food and cosmetics toxicology, Vol.19. pp. 419 to 424. 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- EC Number:
- 221-409-2
- EC Name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Cas Number:
- 3087-16-9
- Molecular formula:
- C27H26N2O7S2.Na
- IUPAC Name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- 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
Constituent 1
- 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 or test system 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.
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