Naphthalene-1,5-disulphonic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted similar to OECD guideline 471 with only minor limitations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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:

Naphthalene-1,5-disulphonic acid

EC Number:

201-317-9

EC Name:

Naphthalene-1,5-disulphonic acid

Cas Number:

81-04-9

Molecular formula:

C10H8O6S2

IUPAC Name:

naphthalene-1,5-disulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): 1,5-Naphtalenedisulfonic acid tetrahydrate
- Physical state: white crystalline powder
- Analytical purity: 77%
- Lot/batch No.: N0074
- Expiration date of the lot/batch: 15 July, 1992
- Storage condition of test material: refrigerator

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

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:

1,5-Naphthalenedisulfonic acid was investigated using the Salmonella/microsome test for point mutagenic effects in doses of 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 of up to and including 150 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strain-specific bacteriotoxic effect. However, this range could nevertheless be used for assessment purposes.

Evidence of mutagenic activity of 1,5-naphthalenedisulfonic acid was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. Therefore, 1,5-naphthalenedisulfonic acid was considered tobe non-mutagenic without and with S9 mix in the Salmonella/microsome test.

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 in­ crease in mutant colonies compared to the corresponding negative controls.