Benzenesulfonic acid, C14-24-alkyl derivatives, magnesium salts, overbased

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: Study conducted to OECD guidelines and to GLP, so therefore meets the criteria of Klimisch code 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, petroleum, calcium salts, overbased

EC Number:

272-213-9

EC Name:

Sulfonic acids, petroleum, calcium salts, overbased

Cas Number:

68783-96-0

Constituent 2

Reference substance name:

petroleum derived,calcium salt

IUPAC Name:

petroleum derived,calcium salt

Details on test material:

The test material (CAS 68783-96-0) is an alkyl aryl sulphonate described as a petroleum derived, calcium salt, overbased.

Method

Target gene:

TK +/-

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9 cells

Test concentrations with justification for top dose:

500, 1000, 1500, 2000, 4000, and 5000 µg/ml

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

Remarks:

with activation

Controls 2

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without activation

Details on test system and experimental conditions:

The test material was suspended in culture and palced on a restricted media containing trifluorothymidine.

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk


DURATION
- Preincubation period: 4 hours
- Exposure duration: 10-12 days


NUMBER OF REPLICATIONS: 2


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Number of colonies/plate.

Statistics:

Mean and standard deviation.

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: Significant toxicity (<90% total growth) at 500 µg/ml occurred both with and without metabolic activation.

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 test material was not genotoxic under the conditions of test.

Executive summary:

In a mammalian cell gene mutation assay, mouse lymphoma L5178Y cells cultured in vitro were exposed to a petroleum derived calcium salt, at concentrations of  500, 1000, 1500, 2000, 4000 and 5000 µg/ml in the presence and absence of mammalian metabolic activation. 

 

The positive controls induced the appropriate response.  There was no evidence of induced mutant colonies over background.

 

This study is classified as acceptable.  This study satisfies the requirement for Test Guideline OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data