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Toxicological information

Genetic toxicity: in vitro

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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

1
Chemical structure
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:
Unknown constituents
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.

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