Benzene mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

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

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study has been conducted to OECD guidelines and to GLP, however, has not been fully reported. In addition, as this study is used in the context of a read across, Klimisch 2 is assigned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

68783-96-0

Cas Number:

68783-96-0

IUPAC Name:

68783-96-0

Constituent 2

Reference substance name:

Sulfonic acids, petroleum, calcium salts, overbased

IUPAC Name:

Sulfonic acids, petroleum, calcium salts, overbased

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Metabolic activation system:

arochlor induced rat liver S9 extract

Test concentrations with justification for top dose:

10, 20,40,80,120,160 ug/ml

Vehicle / solvent:

tetrahydrofuran for test material
acetone for positive control

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium


DURATION
- Exposure duration: 16 and 40 hours


SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giemsa stain


NUMBER OF REPLICATIONS: 2


NUMBER OF CELLS EVALUATED: 200 metaphase cells (100 per culture) each containing 19-23 chromosomes


DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:

Evaluation criteria:

cells with aberrant chromosomes.

Statistics:

Fisher exact test.

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, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitate and/or cloudines were present with and without metabolic activation at concentrations of 39 µg/ml and greater.


RANGE-FINDING/SCREENING STUDIES: There was an 81% reduction in cell survival at 160 µg/ml, without metabolic activation, compared with control.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

In the initial 16h harvest there were statistically significant increases with dose in the % of aberrant cells for both activated and non activated tests. These trends were not reproducible in the repeat 16h harvest and were therefore not considered biologically significant.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test material was not genotoxic under the conditions of this study.

Executive summary:

In a mammalian cell cytogenetics assay [chromosome aberration], CHO cell cultures were exposed to a petroleum derived calcium salt derivative at concentrations of 0, 10, 20, 40, 80, 120 and 160 µg/ml with and without S9 metabolic activation.

 

Positive controls induced the appropriate response.  There was no evidence of chromosome aberrations induced over background with the test substance.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OECD 473 for in vitro cytogenetic mutagenicity data.