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

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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., Hambakenwetering7, 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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... ary Internet Files/Content.Outlook/6RSURWTF/Endpoint study record Genetic toxicity in vitro_ Ames WIL Research 500680.html [9/13/2013 2:29:45 PM] 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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... ary Internet Files/Content.Outlook/6RSURWTF/Endpoint study record Genetic toxicity in vitro_ Ames WIL Research 500680.html [9/13/2013 2:29:45 PM] 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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... ary Internet Files/Content.Outlook/6RSURWTF/Endpoint study record Genetic toxicity in vitro_ Ames WIL Research 500680.html [9/13/2013 2:29:45 PM] 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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... ary Internet Files/Content.Outlook/6RSURWTF/Endpoint study record Genetic toxicity in vitro_ Ames WIL Research 500680.html [9/13/2013 2:29:45 PM] 

### 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.