1,5-Naphthalenedisulfonic acid, 2-[2-[8-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:5)

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:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

84/449/EWG, B.12

Test guideline 2

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:

-

EC Number:

402-420-3

EC Name:

-

Cas Number:

89157-03-9

Molecular formula:

C31H19ClN7Na5O19S6

IUPAC Name:

pentasodium 5-{[4-chloro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Read 239

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

deionised water

Duration of treatment / exposure:

animals were killed after 24, 48 or 72 hours after administration of the test compound

Frequency of treatment:

The test compound was given in two equal parts within two hours

Doses / concentrations

Remarks:

Doses / Concentrations:
6250 mg/kg
Basis:
nominal in water

No. of animals per sex per dose:

Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 6250 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 6250 mg/kg; No. of animals: 5; Sacrifice times: 72 hours

Positive control(s):

endoxane, 50 mg/kg BW

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The incidence of micronucleated polychromatic erythrocytes in the dose groups of Reaktiv-Rot F-52167 FW was within the normal range of the negative control groups. No statistically significant increase of micronucleated polychromatic erythrocytes has been observed.
Due to the colour of the test compound urine, faeces and skin were red coloured.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
not mutagenic

Executive summary:

Reactive Red 239 was tested in the micronucleus test. The test compound was administered orally by gavage to male and female mice. Doses levels of 0 and 6250 mg per kg bodyweight were tested. The 6250 mg per kg bodyweight dose level was chosen since a preliminary study had shown it to be the maximal applicable dose. The test compound was given in two equal parts within two hours and according to the test procedure the animals were killed 24, 48, 72 hours after administration of the test compound.

Endoxan was used as positive control substance and was administered orally at a dose of 50 mg per kg bodyweight.

The incidence of micronucleated polychromatic erythrocytes of the animals treated with Reactive Red 239 was within the normal range of the negative control. The number of normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with Reactive Red 239 and was statistically not different form the control values.

Endoxan induced a marked statistically significant increase in the number of polychromatic cells with micronuclei in both males and females, indicating the sensitivity of the system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extend.

The results indicated that, under the conditions of the present study, Reactive Red 239 is not cytogenic in the micronucleus test.