1,8-naphthylenediamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Several Ames tests and a data from a SOS Chromotest and a QSAR ccaluculation are avaialbe

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and well documented - but only 4 strains tested

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

1,8-naphthylenediamine was investigated using the Salmonella/microsome test (Ames Test) for point mutagenic effects in doses up to 12500 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: all strains are partly deficient in lipopolysaccharide side chains

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

first test: 0, 20, 100, 500, 2500, 12500 µg/plate
repeat test: 0, 0,8, 4, 20, 100, 500 µg/plate

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: endoxan, trypaflavin, 2-aminoanthracen

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 500 µg with and without S-9 mix

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

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

Remarks:

Migrated from field 'Test system'.

The test substance revealed a mutagenic effect on S. typhimurium strains TA 98, TA100 and TA1537. The lowest reproducible and effective doses for S. typhimurium TA 98, TA 100. and TA 1537 were 20 µg/plate.

1,8 -Naphthylenediamine is positive under the conditions of this Ames test with and without metabolic activation.

Conclusions:

Interpretation of results:
positive

Executive summary:

1,8-Naphthylenediamine was investigated using the Salmonella/microsome test (Ames Test) for point mutagenic effects in doses up to 12500 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

The test substance revealed a mutagenic effect on S. typhimurium strains TA 98, TA100 and TA1537. The lowest reproducible and effective doses for S. typhimurium TA 98, TA 100. and TA 1537 were 20 µg/plate.

1,8 -Naphthylenediamine is positive under the conditions of this Ames test with and without metabolic activation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Additional information

Additional information from genetic toxicity in vitro:

In the Ames tests, the SOS Chromotest and the QSAR calculation 1,8-naphthylenediamine are positive

Justification for selection of genetic toxicity endpoint
key study used

Justification for classification or non-classification

The compound is positive in bacterial reverse mutation assays. No other studies are available.