Benzenesulfonic acid, para-, monoalkylation products with C14-C18 branched olefins (C15 rich) derived from propene oligomerization, calcium salt, overbased including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

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:

2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed fully in compliance with the OECD 471 Guideline and according to GLP principles. When used in assessmen to the tested subtsance, the study is considered reliable without restriction according to the criteria of Klimisch, 1997. However, since the study is used in this assessment to evaluate a similar material, the reliability is reduced to reliable with restrictions according to the criteria of Klimisch, 1997.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

not specified

Principles of method if other than guideline:

According to OECD 473 with slight modifications to include confirmatory testing

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

calcium di(alkyl(C20-C24, even numbered)(branched)-methylbenzenesulfonate containing Distillates (petroleum), hydrotreated heavy paraffinic

Cas Number:

722503-68-6

Molecular formula:

CaS2O6(C54-62)(H94-110)

IUPAC Name:

calcium di(alkyl(C20-C24, even numbered)(branched)-methylbenzenesulfonate containing Distillates (petroleum), hydrotreated heavy paraffinic

Details on test material:

Test substance: CAS # 722503-68-6 - Benzenesulfonic acid, methyl-, mono-C20-24-branched, alkyl derivs., calcium salts

Method

Species / strain

Species / strain / cell type:

primary culture, other: Human venous blood

Details on mammalian cell type (if applicable):

Human venous blood from a healthy adult male donor

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor - induced rat liver S9

Test concentrations with justification for top dose:

0, 34.7, 49.5, 70.7, and 101 ug/uL plus positive controls

Vehicle / solvent:

DMSO (10uL/mL) with and without S9 activation

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

RPMI 1640 Media

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

Mitomycin C without activation and Cyclophosphamide in activation

Details on test system and experimental conditions:

See attached study report for details

Evaluation criteria:

chromosomal aberrations, polyploidy, and endoreduplication

Statistics:

See attached study report for details

Results and discussion

Test results

Species / strain:

primary culture, other: human whole blood lymphocytes

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:

See attached study report for details

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

{CAS# 722503 -68 -6} was prepared as a dark brown, viscous, even suspension at a concentration of 505 mg/ml and concentrations of 34.7 to 5060 ug/ml and tested for 3 hours with and without metabolic activation then harvested 22 hours after treatment in the first phase of the chromosomal aberration assay. A precipitate was observed at doses of 854 and higher. Slight to substantial hemolysis was observed in cultures dosed at >/= 205 mg/L. Non-activated cultures treated at </= 293 ug/L and activated cultures treated at </= 205 were analysed for chromosomal aberrations. No significant increase in cells with chromosal aberrations, percent polyploidy or endoreduplication was observed.

The confirmatory trial was conducted with cells treated 19.3 or 43.3 hours without metabolic activation or for 3 hours with metabolic activation and harvested 22 and 46 hours, respectively, after initial treatment. Concentrations of 12.5 to 400 ug/ml were tested without metabolic activation and 25.0 to 300 ug/ml were tested with metabolic activation in this trial. Cultures from the 150, 200 and 250 ug/ml 22 hour non-activation group, from the 25, 50 and 100 ug/ml 46 hour non-activation group and from the 200, 250 and 300 ug/ml 22 and 46 hour activation groups were analyzed for chromosomal aberrations. The high dose selected for each treatment condition showed > 50% reduction in mitotic index as compared to solvent control cultures. No significant increase in cells with chromosomal aberrations, percent polyploidy or endoreduplication was observed in the concentrations analyzed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

{CAS# 722503-68-6} is considered negative for inducting chormosomal aberrations in human whole blood lymphocytes with and without exogenous activation and verified with confirmatory tests with multiple harvests.

Executive summary:

The objective of this in vitro study was to evaluate the ability of {CAS# 722503 -68 -6} to induce chromosomal aberrations in clutured human whole blood lymphocytes with and without metabolic activation. {CAS# 722503 -68 -6} was considered negative for inducing chromosomal aberrations in human whole blood lymphocytes with and without metabolic activation. These results were verified in a confirmatory assay with multiple harvests.