Benzenesulfonic acid, di-C10-14-alkyl derivs., sodium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

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.

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Benzenesulfonic acid, di-C10-14-alkyl derivs., sodium salts
SOURCE: Petroleum derived,calcium salt
3. CATEGORY APPROACH JUSTIFICATION
Linear and non-linear or branched alkylbenzene sulfonates are anionic surfactants with molecules characterized by a hydrophobic (apolar) and a hydrophilic (polar) group. As a group of chemicals, they are generally mixtures of closely related isomers and homologues. Each molecule contains an aromatic ring sulfonated at the para position and attached to either a linear or a branched alkyl chain at any position except the terminal carbons. The sulfonate group is a common functional group present in each of the category members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. The cation components of the chemicals (e.g. calcium, magnesium, sodium, or barium) are not expected to contribute significantly to the toxicity.
4. DATA MATRIX
See Read Across document attached to CSR

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:

68783-96-0

Cas Number:

68783-96-0

IUPAC Name:

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 extract

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 placed 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:

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 with the test substance.

 

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