Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, 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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

EC Number:

931-534-0

Cas Number:

68439-57-6

Molecular formula:

C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6

IUPAC Name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

Constituent 2

Reference substance name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

IUPAC Name:

Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts

Test material form:

other: aqueous formulation

Details on test material:

- Name of test material (as cited in study report): Hostapur OS flüssig
- Physical state: yellow, clear liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: approx. 40 % Olefin sulfonate Na salt, 60 % water; C-chainlengths: ≤C12: max. 1%, C14: approx. 65%; C16: approx. 30%; ≥C18: max. 1.5%
- Lot/batch No.: E06 137 142 dated September 1st, 1988
- Storage condition of test material: dark at 22°C
- Other: Source: Hoechst AG

Method

Target gene:

His-operon, Trp-operon

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA98, 100, 1535, 1537, 1538

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

Experiment 1: 0, 4, 20, 100, 500, 2500, 10000 µg/plate;
Experiment 2: 0, 4, 20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

TA100, TA1535 without S9

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA1535 without S9

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

TA98, TA1538 without S9

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-Methyl-N-nitro-N-nitrosoguanidine

Remarks:

WP2uvrA without S9

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

all strains with S9

Controls 6

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

all strains with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 to 72 h


SELECTION AGENT (mutation assays): histidine and tryptophan prototrophy, respectively


NUMBER OF REPLICATIONS: in triplicate plates


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (surviving fraction); other: reduction of background growth

Evaluation criteria:

Significant increase in the number of revertant colonies, dose dependent effect.

Statistics:

Means of triplicate plates

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA100, 1535, 1537, 1538, 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Starting at 500 µg/plate without S9 and at 2500 µg/plate with S9

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Maximum number of revertants (means) observed in both experiments:

	Mean Max. Revertant number
	-S9		+S9
Strain	Control	Test group (µg/plate)	Control	Test group (µg/plate)
TA100	174	187 (4)	168	180 (4)
TA1535	13	16 (4)	13	14 (4)
TA1537	6	12 (100)	10	10 (4)
TA1538	13	17 (20)	19	25 (20)
TA98	30	29 (20)	32	39 (20)
WP2uvrA	67	68 (4)	75	72 (100)

Conclusion:

There was no significant increase in revertants over control observed in any of the experiments.

Therefore, the test substance is not mutagenic in bacteria under the experimental conditions chosen.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative