Sulfonic acids, C14-17-sec-alkane, sodium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline study, not according to GLP. Conducted according accepted scientific standards. Well conducted and reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no positive controls

GLP compliance:

no

Remarks:

not required at time of performance

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

EC Number:

307-055-2

EC Name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

Cas Number:

97489-15-1

Molecular formula:

H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3

IUPAC Name:

Sulfonic acids, C14-17-sec-alkane, sodium salts

Constituent 2

Reference substance name:

Hostapur SAS 30

IUPAC Name:

Hostapur SAS 30

Details on test material:

- Name of test material (as cited in study report): Hostapur SAS 30
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: liquid
- Analytical purity: 30%
- Composition of test material, percentage of components: 30% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed by sponsor
- Storage condition of test material: no data
- Other:

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from Aroclor 1254 pretreated rats

Test concentrations with justification for top dose:

0,001 - 5 microL/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: appropriate vehicle for this type of test

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation


DURATION
- Preincubation period: 48 hours

Evaluation criteria:

numbers of reverted bacterial colonies

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

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:

not examined

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Water solubility: no
- Precipitation: no
- Other confounding effects: no

Applicant's summary and conclusion

Conclusions:

Sec-alkane sulfonate-sodium salts SAS (30%) tested in 4 bacterial strains of Salmonella typhimurium exhibited no mutagenic effects neither with nor without metabolic activation (S9-mix from Aroclor 1254 pretreated rats)

Executive summary:

Sec-alkane sulfonate-sodium salts SAS (30%) was tested for potential point mutagenic effects in bacteria according to the methodology described by Ames. The study was not conducted according to GLP and OECD test guideline as these were not available at time of performance. However, it followed the scientific standards at this time and is regarded to be valid with restrictions. Sec-alkane sulfonate-sodium salts SAS (30%) was investigated in the Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. The tests were performed in the presence and in the absence of a metabolizing system derived from rat liver homogenate (S9 -mix). A dose range of 0.001 to 5 microliter per plate was used. Based on the results obtained, sec-alkane sulfonate-sodium salts SAS (30%) is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation.