Endpoint study record: Genetic toxicity in vitro. Ames WIL Research 500680

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Printing Date 2013-04-24 13:13:16 CEST

Restriction of specific regulatory purposes

Confidentiality

Owner (TS 204240) 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) / WIL Research Europe B.V. /

's-Hertogenbosch / Netherlands

Legal entity

owner

WIL Research Europe B.V. / 's-Hertogenbosch / Netherlands

Endpoint study record: Genetic toxicity in vitro. Ames WIL

Research 500680

UUID IUC5-92d29dce-3a4c-444e-8f52-1c2d35bf046a

Dossier UUID 0

Author VEC / WIL Research Europe B.V. / 's-Hertogenbosch / Netherlands

Date 2013-04-24 13:13:00 CEST

Remarks

Administrative Data

Purpose flag key study; robust study summary

Study result type experimental result Study period 04-Feb-2013 to 14-Feb-2013

Reliability 1 (reliable without restriction)

Rationale for reliability incl.

deficiencies

The study has been performed according to OECD and/or EC guidelines and according to GLP

principles.

Data source

Reference

Reference

type

Author Year Title Bibliographic

source

Testing

laboratory

Report

no.

Owner

company

Company

study no.

Report

date

study

report

C.M.

VerspeekRip

2013 Evaluation of the

mutagenic activity of 1-

Propanesulfonic acid,

2-hydroxy-3-(2-propen1-yloxy)-, sodium salt

(1:1) in the Salmonella

typhimurium reverse

mutation assay and the

Escherichia coli reverse

WIL Research

B.V.,

Hambakenwetering

7, 5231 DD ‘sHertogenbosch,

The Netherlands

500680 Society of

Chemical

Manufacturers

and Affiliates,

1850 M Street,

NW Suite 700,

WASHINGTON,

DC 20036, USA

2013-

04-10
Endpoint study record: Genetic toxicity in vitro. Ames WIL Research 500680

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mutation assay (with

independent repeat).

Materials and methods

Type of genotoxicity

gene mutation

Type of study

bacterial reverse mutation assay (e.g. Ames test)

Test guideline

Qualifier Guideline Deviations

according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) no

according to EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) no

GLP compliance

yes (incl. certificate)

Test materials

Identity of test material same as for substance defined in section 1 (if not read-across)

yes

Test material identity

Identifier Identity

CAS number 52556-42-0

Test material form

other: liquid

Details on test material

- Name of test material (as cited in study report): 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)

- Substance type: Clear colourless liquid

- Physical state: Liquid

- Storage condition of test material: At room temperature in the dark

Confidential details on test material

- Purity/Composition 

Sodium-1-allyloxy-2-hydroxypropane sulphonate, CAS number: 52556-42-0, Percent: 38.64 

3-allyl-1,2-propanediol, CAS number: 123-34-2, Percent: 2.26

Water, CAS number: 7732-18-5, Percent: 59.1

- Lot/batch No.: 12E1101

- Expiration date of the lot/batch: 13 August 2013

Method

Target gene

- S. typhimurium: Histidine gene

- E. coli: Tryptophan gene

Species/strain

Species/strain S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic

activation

with and without

Metabolic

activation

system

Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone

Species/strain E. coli WP2 uvr A
Endpoint study record: Genetic toxicity in vitro. Ames WIL Research 500680

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Metabolic

activation

with and without

Metabolic

activation

system

Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone

Test concentrations

Experiment 1

Preliminary test (without and with S9) TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 μg/plate 

Main study: TA1535, TA1537 and TA98: 

Without and with S9-mix: 100, 333, 1000, 3330 and 5000 μg/plate

Experiment 2:

Without and with S9-mix: 100, 333, 1000, 3330 and 5000 μg/plate

Vehicle

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

- Justification for choice of solvent/vehicle: 

Test compound was stable in water and water has been accepted and approved by authorities and international guidelines 

Controls

Negative

controls

no

Solvent /

vehicle

controls

yes

Positive

controls

yes

Positive

control

substance

methylmethanesulfonate 650 μg/plate in DMSO for TA100

Remarks without S9

Positive

control

substance

2-nitrofluorene 10 μg/plate in DMSO for TA98 and 15 μg/plate for TA1537

Remarks without S

Positive

control

substance

4-nitroquinoline-N-oxide 10 μg/plate in DMSO for WP2uvrA

Remarks without S9

Positive

control

substance

sodium azide 5 μg/plate in saline for TA1535

Remarks without S9

Positive

control

substance

other: 2-aminoanthracene in DMSO for all tester strains

Remarks with S9

Details on test system and conditions

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION

- Exposure duration: 48 hour

NUMBER OF REPLICATIONS: 

- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
Endpoint study record: Genetic toxicity in vitro. Ames WIL Research 500680

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NUMBER OF CELLS EVALUATED: 10E8 per plate

DETERMINATION OF CYTOTOXICITY 

- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant

colonies.

OTHER EXAMINATIONS: 

- The presence of precipitation of the test compound on the plates was determined.

Evaluation criteria

A test substance is considered negative (not mutagenic) in the test if:

a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of

revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.

b) The negative response should be reproducible in at least one independently repeated experiment.

A test substance is considered positive if:

a) A two-fold (TA100) or more or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean

number of revertant colonies is observed in the test substance group.

b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response

should be reproducible in at least one independently repeated experiment.

Results and discussions

Test results

Species/strain S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic

activation

with and without

Genotoxicity negative

Cytotoxicity no

Vehicle

controls valid

yes

Positive

controls valid

yes

Species/strain E. coli WP2 uvr A

Metabolic

activation

with and without

Genotoxicity negative

Cytotoxicity no

Vehicle

controls valid

yes

Positive

controls valid

yes

Additional information on results

TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: No precipitation was observed up to and including the top dose of 5000 μg/plate

RANGE-FINDING/SCREENING STUDIES: 

- No toxicity or mutagenicity was observed up to and including the top dose of 5000 μg/plate

COMPARISON WITH HISTORICAL CONTROL DATA: 

- The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test

conditions were adequate and that the metabolic activation system functioned properly.

ADDITIONAL INFORMATION ON CYTOTOXICITY:

- No toxicity or mutagenicity was observed up to and including the top dose of 5000 μg/plate

Applicant's summary and conclusion

Interpretation of results

negative
Endpoint study record: Genetic toxicity in vitro. Ames WIL Research 500680

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Conclusions

It is concluded that 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) is not mutagenic in the Salmonella

typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Executive summary

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) did not induce a significant dose-related increase in the

number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant

(Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in

an independently repeated experiment.

In this study, the negative and strain-specific positive control values were within the laboratory historical control data ranges indicating

that the test conditions were adequate and that the metabolic activation system functioned properly.