4-(4-Allyloxy-benzenesulfonyl)-phenol

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:

10 April to 20 May 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at a GLP accredited laboratory to internationally recognised guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

BPS-MAE

IUPAC Name:

BPS-MAE

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): BPS-MAE
- Physical state: White powder
- Analytical purity: 99%
- Lot/batch No.: G130324
- Expiration date of the lot/batch: April 2004
- Storage condition of test material: Room temperature (ca. 20°C)
:

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 pKM 101

Metabolic activation:

with and without

Metabolic activation system:

Liver homogenate derived from Aroclor 1254 induced rats (S-9 mix).

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 1.5, 5, 15, 50, 150, 500, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 1.5, 5, 15, 50, 150, 500, 5000 µg/plate

Vehicle / solvent:

Solvent: Dimethyl sulphoxide (DMSO)

Controls

Controls 1

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (AF-2)

Remarks:

In absence of S-9 mix

Controls 2

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

other: 2-Aminoanthracene

Remarks:

In presence of S-9 mix.

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 5000 µg/plate

Evaluation criteria:

For a test to be considered valid the mean of thle solvent/vehicle control revertant colony numbers for each strain should lie within or close to the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TAl535 and TA1537) the concurrent solvent/vehicle controls.

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:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

Observations:
No evidence of mutagenic activity was seen at any concentration in any of the mutation tests.

Applicant's summary and conclusion

Conclusions:

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

It is concluded that, under the test conditions employed, BPS-MAE showed no evidence of mutagenic activity in this bacterial system.