Bis(isopropyl)naphthalene

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:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

: only four strains tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Bis(isopropyl)naphthalene

EC Number:

254-052-6

EC Name:

Bis(isopropyl)naphthalene

Cas Number:

38640-62-9

Molecular formula:

C16H20

IUPAC Name:

bis(isopropyl)naphthalene

Details on test material:

- Name of test material (as cited in study report): RKKO 131006
- Physical state: colorless liquid
- Analytical purity: no data
- Isomers composition: no data
- Storage condition of test material: at room temperature in the dark

Method

Target gene:

his

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 from Aroclor induced rat liver (Litton Bionetics Inc.)

Test concentrations with justification for top dose:

0, 0.1, 0.3, 1.0, 3.0, and 10.0 µl/plate (0.092 - 9.2 mg/plate)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: insolubility of test substance in water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S-9: Sodium azide (TA100, TA1537), 5-Nitrofluorene (TA98), 9-Aminoacridine (TA1537); with S-9: 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3 days
- Expression time (cells in growth medium): 3 days at 37° C

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; toxicity of the test substance was evaluated in a separate test by incubating tester strain TA100 with 10 graduate concentrations of test substance (0 - 200 µL/plate, spacing factor 2).

Evaluation criteria:

- The solvent/vehicle control has to show an adequate number of revertants.
- A dose-response relationship must be demonstrated at least for one tester strain.
- The maximum number of revertants must be at least double of spontaneous revertants.
- The result must be reproducible.

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:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

no toxicity to TA 100 up to 200 µl/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance proved to be insoluble at 12.5 µl and higher, i.e. above recommended maximum test concentration of 5 mg/pl.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance did not induce mutant colonies above background in any strain at any concentration tested.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In a bacterial reverse mutation assay using four strains of S. typhimurium, there was no evidence of an increase in revertant colonies above background in any strain and at any concentration tested with and without metabolic activation. Diisopropylnaphthalene proved to be negative in the Ames test under the test conditions used.