Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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

Constituent 1
Chemical structure
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.