Sodium dodecylbenzenesulfonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

other: published data

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Dodecylbenzene sulfonic acids (CAS# 27176-87-0 , EC Number; 248-289-4) ) is a very close analogue of Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0, EC Number; 246-680-4) ) and the dissociated acid it readily dissociates in water and release the dodecylbenzene sulfonic anion in solution.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodecylbenzenesulphonic acid

EC Number:

248-289-4

EC Name:

Dodecylbenzenesulphonic acid

Cas Number:

27176-87-0

Molecular formula:

C18H30O3S

IUPAC Name:

Dodecylbenzenesulfonic acid

Test material form:

other: liquid

Details on test material:

- KIT Code No.: K-2698- Supplier: Korea Chemicals Management Association (KCMA)- Lot No.: 080108C105- Purity: 96.87%- Molecular Weight: 326.54- Density: 1.0550 at 20 deg C- Date of Receipt: January 14, 2008- Quantities received: 3 kg- Appearance: Liquid- Life time: January 8, 2009- Storage Conditions: Room Temperature [Archives No.: KIT-401(106)]

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

- Species and cell type: Rat (Sprague Dawley strain), male, liver - Quantity: 5 % S9 mix induced with Aroclor 1254

Test concentrations with justification for top dose:

- TA 98: 23.44, 46.88, 93.75, 187.5, 375, 750, 1,500 μg/plate (-)
- TA 98: 5.86, 11.72, 23.44, 46.88, 93.75, 187.5, 375, 750, 1,500, 3,000 μg/plate (+)
- TA 100: 5.86, 11.72, 23.44, 46.88, 93.75, 187.5 μg/plate (-)
- TA 100: 23.44, 46.88, 93.75, 187.5, 375, 750 μg/plate (+)
- TA 1535: 5.86, 11.72, 23.44, 46.88, 93.75, 187.5 μg/plate (-)
- TA 1535: 23.44, 46.88, 93.75, 187.5, 375, 750 μg/plate (+)
- TA 1537: 5.86, 11.72, 23.44, 46.88, 93.75, 187.5 μg/plate (-)
- TA 1537: 23.44, 46.88, 93.75, 187.5, 375, 750 μg/plate (+)
- WP2uvrA: 5.86, 11.72, 23.44, 46.88, 93.75, 187.5 μg/plate (-)
- WP2uvrA: 23.44, 46.88, 93.75, 187.5, 375, 750, 1500 μg/plate (+)

Vehicle / solvent:

Dimethylsulfoxide

Controls

Untreated negative controls:

yes

Remarks:

Dimethylsulfoxide

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulfoxide

Positive controls:

yes

Positive control substance:

other: 2-Nitrofluorene, Sodium azide, 9-Aminoacridine, 4-Nitroquinoline 1-oxide ,2-Aminoanthracene and Benzo(a)pyrene

Details on test system and experimental conditions:

- Number of replicated: 3 plates/dose - Dose range finding experiment was carried out using dose levels of 8, 40, 200, 1,000, 3,000 and 5,000 μg/plate both in the absence and in the presence of metabolic activation system.- Cytotoxicity: A preliminary toxicity test was performed to define the concentrations to be used for the mutagenicity study.

Evaluation criteria:

The assay was considered valid if the number of spontaneous revertant colonies in vehicle control plates falls within the normal range and the positive control chemicals induce significant increases in the number of mutagen-induced revertant colonies compared to vehicle control. It was judged to be positive if there was a concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without the metabolic system. In addition, it was judged to have a toxic effect (antibacterial effect) when a clearing or diminution of background lawn, the appearance of micro-colonies, and/or thedecrease more than 50% in the number of colonies compared to that of vehicle control was observed.

Results and discussion

Test results

Test results 1

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:

cytotoxicity

Remarks:

≥375 μg/plate (+) (TA 100, TA 1535, TA 1537) ≥93.75 μg/plate (-) (TA 100, TA 1535, TA 1537) ≥1500 μg/plate (+) (TA 98) ≥375 μg/plate (-) (TA 98)

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

≥750 μg/plate (+) (WP2 uvr ) 1500 μg/plate (+) (WP2 uvr )

Remarks on result:

other: strain/cell type: TA 98, 100, 1535, 1537 and WP2 uvr A

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Bacterial tests

A bacterial reverse mutation test was performed in accordance with [OECD TG 471] using Salmonella typhimurium (strains TA98,TA100, TA1535 and TA 1537) and Escherichia coli (strain WP2uvrA) with and without a metabolic activation system. Test doses were as follows:

	5.86, 11.72, 23.44, 46.88, 93.75, 187.5, 375, 750, 1,500, 3,000μg/plate (+/-)

 

Dimethylsulfoxide (DMSO) was used as a vehicle and Sodium azide (SA), 2-Nitrofluorene (2-NF), 9-Aminoacridine (9-AA), 4-Nitroquinoline 1-oxide (4NQO),2-Aminoanthracene (2-AA)andBenzo(a)pyrene (BP)were used as positive control item.In all strains used, there was no increase in the number of revertant colonies compared to the vehicle control at any concentration of dodecylbenzenesulfonic acid either in the presence or absence of metabolic activation system. However, in the first and second experiment, it was observed a clearing or diminution of background lawn, the appearance of micro-colonies, and/or more than 50% decrease in the number of colonies at more than 375 μg/plate and 93.75 μg/plate in TA100, TA1535 and TA1537 strains in the presence and absence of S9 activation, respectively. Also, in TA98 strain, it was observed a clearing or diminution of background lawn, the appearance of micro-colonies, and/or more than 50% decrease in the number of colonies at more than 1500 μg/plate and 375μg/plate in the presence and absence of S9 activation, respectively. InE. coliWP2uvrA strain, the more than 50% decrease in the number of colonies was observed at more than 750μg/plate and at 1500 μg/plate in the presence of S9 activation in the first and second experiment, respectively. The positive controls induced a significant increase in the numbers of revertant colonies indicating the assay was valid.

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results :negative

In the presence and absence of metabolic system, no mutation in the Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) and Escherichia coli (strain WP2 uvrA) occurred with dodecylbenzenesulfonic acid (as a read across for Sodium dodecylbenzenesulfonate) .