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Toxicological information

Genetic toxicity: in vitro

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and well documented - but only 4 strains tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 96.6%

Method

Species / strain
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
Controls
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

Results and discussion

Test results
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'.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.