Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]

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:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 267

IUPAC Name:

Direct Blue 267

Test animals

Species:

mouse

Strain:

NMRI

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

distilled water

No. of animals per sex per dose:

15 males at 400 mg/kg sacrificed at 24, 48 an 72h ( 5 males at each time point)15 females at 400 mg/kg sacrificed at 24, 48 and 72h (5 females at each time point)

Results and discussion

Test results

Sex:

not specified

Genotoxicity:

negative

Remarks:

P/N ratio not significantly changed

Toxicity:

yes

Additional information on results:

No apparent citotoxicity effect: PCE/NCE ratio

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negativeThe substance was tested for in vivo genotixicity following in vivo test OECD 474. Under the experimental conditions the P/N is not significantly changed.

Executive summary:

The substance was tested for in vivo genotixicity following in vivo test OECD 474. Mice were orally dosed at 400 mg/kg (maximum tolerated dose) and sacrified at 24, 48 and 72h. No apparent citotoxicity was observed and the P/N was not significantly changed.