1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxypropyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt (1:6)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2006-02-22 to 2006-03-15

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

476-99-6

IUPAC Name:

476-99-6

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

deionised water

Details on exposure:

substance formulated in vehicle

Duration of treatment / exposure:

animals received the test item once

Frequency of treatment:

once

Post exposure period:

24 h, 48 h

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
2000 mg/kg body weight
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
1000 mg/kg body weight
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
500 mg/kg body weight
Basis:
actual ingested

No. of animals per sex per dose:

main experiment:
high dose: 24 animals (12 males/12 females)
mid dose: 12 animals (6 males/6 females)
low dose: 12 animals (6 males/6 females)

Control animals:

yes, concurrent vehicle

Positive control(s):

Cyclophosphamide, 40 mg/kg b.w; 24 h;

Examinations

Tissues and cell types examined:

bone marrow cells; polychromatic erythrocytes; normochromatic erythrocytes

Details of tissue and slide preparation:

according guideline

Evaluation criteria:

standard

Statistics:

nonparametric Mann-Whitney test

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

within 1 h after treatment with 2000 mg/kg b.w.

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Based on the experimental conditions reported the oral application of the substance to mice did not induce micronuclei as determined by the micronucleus test in the bone marrow cells (polychromatic erythrocytes).