Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the genotoxic potential. Source study has reliability 2: only limited information available from a migrated NONS file, as per Article 25(3) request.

Data source

Reference

Reference Type:

other: information from migrated NONS file, as per Article 25(3) request; permission to refer granted by ECHA

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Principles of method if other than guideline:

The method used was that of Prival and Mitchell (Mutat Res 97; 103-116:1982), using a metabolising system favourable to azo reduction (uninduced hamster liver S9, a modified list of co-factors, and a pre-incubation period of 30 minutes).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01

IUPAC Name:

Similar substance 01

Test material form:

solid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

uninduced hamster liver S9

Test concentrations with justification for top dose:

10-5000 µg per plate

Vehicle / solvent:

Distilled water.

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Congo Red

Remarks:

the positive control substance used in the presence of metabolic activation gave a satisfactory positive response

Results and discussion

Test results

Test results 1

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

not specified

Genotoxicity:

other: n.a.

Cytotoxicity / choice of top concentrations:

other: n.a.

Vehicle controls validity:

other: n.a.

Untreated negative controls validity:

other: n.a.

True negative controls validity:

other: n.a.

Positive controls validity:

other: n.a.

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

possible effects starting at 1000 µg/plate (details reported below)

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

possible effects starting at 1000 µg/plate (details reported below)

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Toxic concentrations

Weak toxic effects were seen in TA 98 at 1000 µg/plate with S9 in one of two experiments and in TA 1537 at 1000 µg/plate without S9 in one of three experiments. The substance was also toxic to TA 1537 in one out of three experiments at 5000 µg/plate with and without S9.

Observations

In one experiment a slight increase in revertants in strain TA 1537 was observed after 100 µg/plate without S9 and at 10, 100, 1000 and 5000 µg/plate with S9. These increases were not observed in two subsequent repeat experiments. No other increases in revertants were observed.

Applicant's summary and conclusion

Conclusions:

Non mutagenic with and without the metabolic activation.

Executive summary:

Method

The test has been conducted according to the Prival and Mitchell method (Mutat Res 97; 103-116:1982). Information derived from migrated NONS file, as per Article 25(3) request with permission to refer granted by ECHA.

Strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 were used with and without S9 metabolic activation.

Results

In one experiment a slight increase in revertants in strain TA 1537 was observed at 100 µg/plate without S9 and at 10, 100, 1000 and 5000 µg/plate with S9. Such increases were not confirmed by two subsequent experiments. No other increases in revertants were observed.

Overall, test substance was considered as non mutagenic to bacteria.