N-(2-chloroethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]-N-ethyl-m-toluidine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

in vivo Mammalian genotoxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Part of a review of azo dyes used in food industry in an attempt to consider potential for in-vivo mutagenic effects

Data source

Reference

Reference Type:

publication

Title:

Lack of genotoxic effect of food dyes amaranth, sunset yellow and tartrazine and their metabolites in the gut micronucleus assay in mice

Author:

Poul, M et al

Year:

2008

Bibliographic source:

Food and chemical toxicology, 47 (2009) 443-448

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Principles of method if other than guideline:

Measure of effects in colon cells following oral administration

GLP compliance:

not specified

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

EC Number:

220-491-7

EC Name:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

Cas Number:

2783-94-0

Molecular formula:

C16H12N2O7S2

IUPAC Name:

6-Hydroxy-5-((4-sulphophenyl)azo)naphthalene-2-sulphonic acid

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male

Details on test animals or test system and environmental conditions:

Mice were 6 weeks of age and housed in plastic cages, in an air-conditioned room at 19–23 C and a 12 h light: 12 h dark cycle.
Mice were fed ad libitum with a commercial pelleted diet and were allowed tap water.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Water

Duration of treatment / exposure:

Two administrations, 24 hours apart

Frequency of treatment:

Daily

Post exposure period:

24 hours

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 000 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

200 mg/kg bw/day (nominal)

No. of animals per sex per dose:

7

Control animals:

yes, concurrent vehicle

Positive control(s):

Dimethylhydrazine

Examinations

Tissues and cell types examined:

Colon

Details of tissue and slide preparation:

Stained with Feulgen-fast green after hydrolysis 1 h at 60–65 C in molar HCl
For each animal, over 1000 epithelial cells were scored manually
Cells were scored as normal, micronucleated, apoptotic or mitotic cells.

Evaluation criteria:

Cells were scored as normal, micronucleated, apoptotic or mitotic cells.

Statistics:

Pearson’s v2 test

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No reported adverse effects on the animals

Applicant's summary and conclusion

Conclusions:

Oral exposure to this azo dye did not induce genotoxic effect in the gut micronucleus assay in mice.