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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Sister chromatid exchange induced by secondary and tertiary amine containing dyes and in combination with nitrite in vivo in mice
Author:
A.K. Giri and A. Mukherjee
Year:
1990
Bibliographic source:
Cancer Letters, 52 (1990) 33-37

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Data is from Journal with permission
Principles of method if other than guideline:
Genetic toxicity in vivo test was performed on Swiss albino mice using sister chromatid exchange(SCE) by Fast green FCF.
GLP compliance:
not specified
Type of assay:
sister chromatid exchange assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
EC Number:
219-091-5
EC Name:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
Cas Number:
2353-45-9
Molecular formula:
C37H36N2O10S3.2Na
IUPAC Name:
disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)-5-hydroxybenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Fast Green FCF (2353-45-9)- Molecular formula (if other than submission substance): C37-H36-N2-O10-S3.2Na- Molecular weight (if other than submission substance): 808.8576 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available - Impurities (identity and concentrations): No data available

Test animals

Species:
mouse
Strain:
other: Swiss albino
Sex:
male
Details on test animals or test system and environmental conditions:
Details on test animals and env conditionsTEST ANIMALS- Source: Laboratory bred- Age at study initiation: 12 weeks old- Weight at study initiation: 30 g- Assigned to test groups randomly: No data available- Fasting period before study: No data available- Housing: housed in batches of five inpolycarbonate cages with bedding of ricehusks.- Diet (e.g. ad libitum): food pellets (Lipton India Ltd.) ad libitum.- Water (e.g. ad libitum): ad libitum.- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used :Distilled water- Justification for choice of solvent/vehicle: No data available- Concentration of test material in vehicle: No data available- Amount of vehicle (if gavage or dermal): No data available- Type and concentration of dispersant aid (if powder): No data available- Lot/batch no. (if required): No data available- Purity: No data available
Details on exposure:
No data available
Duration of treatment / exposure:
No data available
Frequency of treatment:
Ones
Post exposure period:
No data available
Doses / concentrations
Remarks:
Doses / Concentrations:5, 10, 25, 50 and 100 mg/kg body weightBasis:actual ingested
No. of animals per sex per dose:
5/dose
Control animals:
not specified
Positive control(s):
Positive controls: mitomycin-C - Justification for choice of positive control(s): No data available- Route of administration: No data available- Doses / concentrations: 2.5 mg/kg body weight

Examinations

Tissues and cell types examined:
Bone marrow cell
Details of tissue and slide preparation:
Details of tissue and slide preparationCRITERIA FOR DOSE SELECTION: No data available TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No data availableDETAILS OF SLIDE PREPARATION: Differential staining of SCE was carried out by a modification of the fluorescence plus Giemsa (FPG) technique. The slides were coded and 20 second generation metaphase cells per dose (only those with 40 chromosomes) were scored from each animal.
Evaluation criteria:
sister chromatid exchanges/cell
Statistics:
For all statistical analyses, the level of significance was established at an alpha of 0.05. A one-tailed Cochran-Armitage trend test was used to determine if a treatment-related increase occurred for SCE data. In addition, pairwise comparisons between each treatedgroup and the negative control group were conducted using the t-test with the alpha level Bonferroni-corrected for multiple comparisons to determine the minimal effective dose for SCE induction. Duncan’s multiple range test was carried out following ANOVA for comparison between the dyes (individually) and dye plus nitrite treated groups. Selection of dose was based on our earlier studies and that on the guidelines of WHO. The doses of IC and of FGFCF were reduced by 50% when the dyes were tested in combination with sodium nitrite to detect whether there was any synergistic effect or not.

Results and discussion

Test results
Sex:
male
Genotoxicity:
positive
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positiveThe genetic toxicity for Fast Green FCF (2353-45-9) was found to be positive in Swiss albino male mice.
Executive summary:

Gene toxicity in vitro study was performed for the test chemical Fast Green FCF in Swiss Albino male mice.

Under anaesthesic condition each mouse was implanted subcutaneously in the neck with a 50-mg tablet of 5-bromodeoxyuridine (BrDU) prior to treatment with chemicals. Fast Green FCF were dissolved in distilled water and were given separately to mice as a single i.p. injection at different concentration of 5, 10, 25, 50 and 100mg/kg body weight one hour after BrdU tablet implantation. The positive control is mitomycin-C (2.5mg/kg body weight) and negative control is distilled water were injected separately to other mice. After 24 hours the mice were killed by cervical dislocation and differential staining of sister chromatid exchange was carried out. The slides were coded and 20 second generation metaphase cells per dose (only those with 40 chromosomes) were scored from each animal.

From the study it was found that 10 mg of FGFCF induced a significantly higher number of SCEs/cell than the negative control.These concentrations were the minimum effective dose for the chemicals.

So from the above study it was concluded that Fast Green FCF (2353-45-9) was found to be positive for genetic toxicity test to Swiss albino mice.

According to the publication, the test material is a positive gene mutant.