Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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. 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 to be non-mutagenic without and with S9 mix in the Salmonella/microsome test.

Link to relevant study records
Reference
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.
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
Target gene:
his operon
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)
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
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'.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

No data available

Additional information

The Ames test was performed with the following four Salmonella typhimurium strains: TA 1535, TA 100, TA 1537 and TA 98.

TA 102 or E. coli WP2 was not included in the test. Since the test compound has no oxidizing or cross-linking activities and does not contain a hydrazine substructure no further testing is necessary; see OECD TG 471 paragraph 13. In addition no mutagenic acitivity was seen in a recent Ames test accoring to OECD TG 471 including E.coli WP2 for 1,5-Naphthalenedisulfonic acid, disodium salt monohydrate (unpublished report).

Justification for classification or non-classification