1,5-naphthylenediamine

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline defined.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Principles of method if other than guideline:

Method: other: bacterial reverse mutation assay ( Ames test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,5-naphthylenediamine

EC Number:

218-817-8

EC Name:

1,5-naphthylenediamine

Cas Number:

2243-62-1

Molecular formula:

C10H10N2

IUPAC Name:

1,5-naphthylenediamine

Details on test material:

IUCLID4 Test substance: other TS: purity 99.2 %

Method

Target gene:

ames assay: detection of base pair substitutions and frameshift mutations

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Test concentrations with justification for top dose:

20-12500 µg/plate

Controls

Positive controls:

yes

Positive control substance:

other: Sodium azide; Nitrofurantoin; 4-nitro-1,2-phenylene diamine; 2-aminoanthracene

Details on test system and experimental conditions:

IUCLID4 Type: Ames test

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Summary of the results with 1,5 -naphtylene diamine (sublimated, ground) in the Salmonella/microsome test:

S9 mix	TA 1535	TA 100	TA 1537	TA 98
without	negative	positive	weak positive	positive
with	negative	positive	weak positive	positive

Applicant's summary and conclusion

Executive summary:

The test substance was tested in a Salmonella microsome test with 20-12500 µg/plate.

Doses up to 1600 µg/plate did not cause bacteriotoxic effects.

 Higher doses showed bacteriotoxicity and substance precipitation occurred at the highest dose level, therefore
12500 µg/plate were not interpretable.
On strains TA 1537, TA 98 and TA 100 a biologically relevant increase of revertants were found with and without metabolic
activation; the effect was more pronounced with S9-mix. The lowest effective dose was 200 µg/plate.

The genotoxicity of the test substance was found to be positive.