Disodium naphthalene-1,5-disulphonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Study period:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP compliant study conducted similar to OECD guideline 471 with only minor limitations. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four tester strains investigated, limited purity of 77%

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium naphthalene-1,5-disulphonate

EC Number:

216-732-0

EC Name:

Disodium naphthalene-1,5-disulphonate

Cas Number:

1655-29-4

Molecular formula:

C10H8O6S2.2Na

IUPAC Name:

disodium naphthalene-1,5-disulphonate

Test material form:

solid: crystalline

Details on test material:

Test item: Armstrongsäure-di-Natriumsalz
CAS name: 1,5-Naphthalenedisulfonic acid, sodium salt (1:2)
CAS number: 1655-29-4
Empirical formula: C10H6O6S2 * 2Na
Molecular mass: 332.3 g/mol

Specific details on test material used for the study:

1,5-Naphtaline disulfonic acid, disodium salt

65.0 % 1,5-Naphtaline disulfonic acid
23% Water
10.8 % Sodium

Method

Target gene:

his operon

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with Aroclor 1254.

Test concentrations with justification for top dose:

Experiment I:
- 8, 40, 200, 1000 and 5000 µg/plate (with and without metabolic activation)
Experiment II:
- 150, 300, 600, 1200, 2400 and 4800 µg/plate (with and without metabolic activation)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9-mix: sodium azide, 10 µg/plate (TA 1535); nitrofurantoin, 0.2 µg/plate (TA 100); 4-nitro-1,2-phenylene diamine, 10 µg/plate (TA 1537) and 0.5 µg/plate (TA 98); with S9-mix: 2-aminoanthracene, 3 µg/plate (TA 1535, TA 1537, TA 98 and TA 100)

Remarks:

DMSO was used as vehicle for the positive controls

Results and discussion

Test results

Key result

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

No increase in revertant count was observed

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A significant decrease in bacterial count (titre assessment) was observed ≥200 µg/plate (TA 1535, TA 100, TA 98) and ≥600 µg/plate (TA 1537)

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

disodium-naphthalene-1,5 -disulfonate was investigated using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed.

Evidence of mutagenic activity of Armstrong acid was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.