N-(2-ethylhexyl)naphthalen-2-amine

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: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

4 strains and standard plate test only.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

56358-17-93

IUPAC Name:

56358-17-93

Constituent 2

Reference substance name:

N-(2-ethylhexyl)naphthalen-2-amine

EC Number:

260-126-9

EC Name:

N-(2-ethylhexyl)naphthalen-2-amine

Cas Number:

56358-17-9

Molecular formula:

C18H25N

IUPAC Name:

N-(2-ethylhexyl)naphthalen-2-amine

Details on test material:

- Name of test material (as cited in study report): Naphthyl-ethylhexylamin (ohne Lösemittel)
- Physical state: solid
- Storage condition of test material: at 4-6 °C

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

20-5000 µg/plate (TA98, TA1537); 20-7500 µg/plate (TA100, TA1535)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [DMSO;]
- Justification for choice of solvent/vehicle: none given, the test substance was not completely soluble in DMSO from about 2500 µg/plate onward

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S-9 mix for strains TA100, TA98, TA1537 and TA1535

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitroso-guanidine (MNNG)

Remarks:

without S-9 mix for strains TA100 and TA1535

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

without S-9 mic for strain TA98

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine chloride

Remarks:

without S-9 mix for strain TA1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: standard plate test

DURATION
- Exposure duration: 48 hours at 37°C in the dark

SELECTION AGENT (mutation assays): his+ revertants

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Statistics:

no data

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

Remarks:

only with S-9 mix in strains TA100 and TA1535

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No increase in the number of his+ revertants was observed without S-9 mix in all strains tested.

No increase in the number of his+ revertants was observed with S-9 mix in the strains TA1537 and TA98.

TA1535: Positive reaction from about 500 µg/ plate (factor 2.1 - 2.8) onward with an increase in the number of mutant colonies by a factor of 5.4 - 5.5 at 5000 µg - 7500 µg/plate.

TA100: Slight increase in the number of his+ revertants in a dose range of 2500 µg - 7500 µg/plate (factor 1.6 - 2.2).