Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

other: In vitro Mammalian Cell Gene Forward Mutation Test

Test material

Test material information

1

Reference substance name:

Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

EC Number:

249-236-8

EC Name:

Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

Cas Number:

28804-46-8

Molecular formula:

C16H14Cl2

IUPAC Name:

Reaction product of tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene with chlorine

Test material form:

solid: granular

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

ethylmethanesulphonate

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

It is concluded that DPX-C (Di-Cloro-Di-p-Xililene) does not have potential to induce gene mutations at the hprt locus of CHO-K1 cells both in the absence and presence of metabolic activation system (2% v/v S9 mix).

Executive summary:

In a mammalian cell gene mutation assay [hprtlocus], CHO-K1 cells culturedin vitrowere exposed toDPX-C (Di-Cloro-Di-p-Xililene)at different concentrations, both in the absence and presence of metabolic activation (2% v/v S9 mix) for a period of 4 hours.

Cultures were exposed toDPX-C (Di-Cloro-Di-p-Xililene)at 6 dose-levels (two cultures/dose-level) between 2.5 and 60 µg/mL of culture medium, selected from a cytotoxicity test both in the absence and presence of metabolic activation (2% v/v S9 mix) for a period of 4 hours.

A significant dose-related increase in the mutation frequency was not observed in any of the treatment concentrations between 2.5 and 60 µg/mL of culture medium both in the absence and presence of metabolic activation system (2% v/v S9 mix) and the induced mutation frequency was comparable to that from the negative control group. All negative controls were within the historical limits and positive controls showed an increase in the mutant frequency. No relevant influence of the test item on pH value or osmolality was observed both in the absence and presence of metabolic activation.

All criteria for a valid study were met as described in the study plan. Based on the results from this study, it is concluded thatDPX-C (Di-Cloro-Di-p-Xililene)does not have potential to induce gene mutations at thehprtlocus of CHO-K1 cells both in the absence and presence of metabolic activation system (2% v/v S9 mix) under the present experimental conditions.