Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs.

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:

Nov. 13, 1989-Jan. 19, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, mono-C10-14-alkyl derivs., fractionation bottoms

EC Number:

285-591-5

EC Name:

Benzene, mono-C10-14-alkyl derivs., fractionation bottoms

Cas Number:

85117-41-5

IUPAC Name:

85117-41-5

Constituent 2

Reference substance name:

Benzene, mono-C10-14-alkyl derivatives, fractionation bottoms

IUPAC Name:

Benzene, mono-C10-14-alkyl derivatives, fractionation bottoms

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Metabolic activation system:

S9 from Aroclor 1254 induced rat liver

Test concentrations with justification for top dose:

5.0 - 80.0 nl/ml

Vehicle / solvent:

ethanol

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: ethylmethanesulfonate, cyclophosphamide

Details on test system and experimental conditions:

The study was conducted using standard OECD protocols. Preparation of chromosomes was done 7 hours (high dose), 24 hours (low, medium, and high dose) and 30 hours (high dose) after start of treatment with the test material. The treatment interval was 4 hours. Treatment was performed with the following test concentrations, with and without S9 activation:

7h: 10, 30, 60, 80 nL/mL
24h: 1, 5, 10, 30, 60, 80 nL/mL
30h: 10, 30, 60, 80 nL/mL

In each experimental group two parallel cultures were used.

Evaluation criteria:

Per culture 100 metaphases were scored for structural chromosomal aberrations.

Statistics:

Statistical significance was evaluated using the chi-square test (p<0.05).

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No significant differences between aberration rates in the treatments vs. the controls was observed. The mitotic index was not, or only slightly, reduced after treatment with the highest dose level.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Results of Cytogenicity Assay in CHO Cells

Dose per ml	S9	% aberrant cells including gaps	% aberrant cells including gaps	Cell exchanges
7 hrs
Solvent	No	3.50	1.50	0.00
80 nl	No	5.00	2.00	0.50
Solvent	Yes	15.00	5.00	1.00
80 nl	Yes	10.00	3.50	0.00
24 hrs
Control	No	7.00	2.50	1.50
Solvent	No	4.00	3.00	1.00
EMS 0.72 mg	No	17.00	16.00	11.00
5.0 nl/ml	No	2.50	2.00	0.00
30 nl/ml	No	2.50	2.00	0.50
80 nl/ml	No	4.50	3.50	0.50
Control	Yes	9.50	4.50	1.00
Solvent	Yes	3.00	3.00	0.50
CPA 4.2 ug	Yes	60.50	58.50	33.00
5.0 nl	Yes	5.50	2.00	1.50
30 nl	Yes	4.50	2.50	1.00
80 nl	Yes	4.00	3.00	0.00
30 hrs
Solvent	No	6.00	3.50	1.00
60.0 nl	No	4.50	0.00	0.00
Solvent	Yes	8.50	5.00	0.50
80.0 nl	Yes	2.00	0.00	0.00

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance was not mutagenic in either the presence or absence of metabolic activation.

Executive summary:

This study examined the potential for the test substance to cause mutations. Chinese hamster ovary (CHO) cells were exposed to concentrations of 5.0 - 80.0 nL/mL of test substance both in the presence and absence of metabolic activation. After the exposure period, the cells were examined for chromosomal aberrations. Ethylmethanesulfonate and cyclophosphamide were used as positive control substances. No increases in chromosomal aberrations were seen in either the presence or absence of metabolic activation. The test substance is not mutagenic.