A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD 476.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Mono-, and di-(sec-hexadecyl)naphthalene

EC Number:

930-936-3

Molecular formula:

C26H40 + C42H72

IUPAC Name:

Mono-, and di-(sec-hexadecyl)naphthalene

Constituent 2

Reference substance name:

MCP 917

IUPAC Name:

MCP 917

Details on test material:

- Name of test material (as cited in study report): MCP 917
- Physical state: pale yellow liquid

Method

Target gene:

Thymidine Kinase

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Details on mammalian cell type (if applicable):

- Type and identity of media: Fischer's medium supplemented with heat-inactivated horse serum (10%), sodium pyruvate (1mM) and Pluronic (0.1%)
- Properly maintained: yes

Additional strain / cell type characteristics:

other: subclone 3.7.2C

Metabolic activation:

with and without

Metabolic activation system:

S-9

Test concentrations with justification for top dose:

0.8 to 10 ul/ml

Vehicle / solvent:

acetone

Controls

Untreated negative controls:

yes

Remarks:

acetone

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Remarks:

two positive controls

Positive control substance:

ethylmethanesulphonate

Remarks:

EMS for non-activated culture, DMBA for the activated culture

Migrated to IUCLID6: DMBA

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 65-72 hours
- Exposure duration: 3 hours
- Expression time (cells in growth medium): 48 hours

NUMBER OF CELLS EVALUATED: 2 x 10^5 cells per culture

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency and relative total growth

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: There were no signs of toxicity at the highest soluble doses of the test material.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The in vitro gene mutation assay in mammalian cells to assess the genotoxicity of the read-across substance, MCP 917, was non-mutagenic with or without activation. This finding does not warrant the classification of the submission substance as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The test material was examined for its potential to induce mutations in the mouse lymphoma L5178Y/TK+/- cell line, in both the presence and absence of an S9 metabolic system. The test material did not induce a statistically significant dose-dependent increase in gene mutation frequency with or without activation. Under the conditions of this study, the test material was non-mutagenic. This finding does not warrant the classification of the test material as a genotoxin under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.