Printing Date 2013-09-02 12:44:14 UTC 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. / 'sHertogenbosch / Netherlands Legal entity owner WIL Research Europe B.V. / 's-Hertogenbosch / Nethe rlands 

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# Endpoint study record: Short - term toxicity to fish. WIL Research

500677

Administrative Data

Data source Reference



# Materials and methods Test guideline
GLP compliance 

# Test materials Identity of test material same as for substance def ined in section 1 (if not read-across) Test material identity
Test material form Details on test material UUID IUC5
- 9e505c14 - 2e1d - 4ecd - 8112 - 48a34ab4665b Dossier UUID 0 Author BOL / WIL Research Europe B.V. / 's
- Hertogenbosch / Netherlands Date 2013 - 09 - 02 12:43:29 UTC Remarks
Purpose flag key study; robust study summary Study result type experimental result Study period 13 May 2013 - 17 May 2013 Reliability 1 (reliable without restriction) Rationale for reliability incl. deficiencies This study has been performed according to OECD and /or EC guidelines and according to GLP principles.

Reference type Author Year Title Bibliographic source Testing

laboratory Report

no. Owner

company Company

study no. Report

date study report L.M.

Bouwman 2013 96-HOUR ACUTE

TOXICITY STUDY IN FATHEAD MINNOW WITH 1- PROPANESULFONIC ACID, 2-HYDROXY-3- (2-PROPEN-1- YLOXY)-, SODIUM SALT (1:1) (STATIC) - WIL Research Europe B.V., Hambakenwetering7, 5231 DD, 'sHertogenbosch, The Netherlands 500677 Society of Chemical Manufacturers and Affiliates, 1850 M Street, NW Suite 700, WASHINGTON, DC 20036 USA - 2013- 07-18

Qualifier Guideline Deviations according to EPA OPPTS 850.1075 (Freshwater and Sal twater Fish Acute Toxicity Test) (1996) no according to OECD Guideline 203 (Fish, Acute Toxici ty Test) (1992) no
yes

yes Identifier Identity CAS number 52556-42-0; 123-34-2 and 7732-18-5 other: Clear colourless liquid Molecular formula: C6H11NaO5S Molecular weight: 218.22 Description: Clear colourless liquid Batch: 12E1101 Purity/Composition Sodium-1-allyloxy-2- hydroxypropane sulphonate 3-allyl-1,2-propanediol Water CAS Number 52556-42-0 123-34-2 7732-18-5 Percent 38.64 

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## Analytical monitoring Details on sampling

Details on analytical methods

Vehicle Details on test solutions


# Test organisms Test organisms (species) Details on test organisms



# Study design Test type Water media type 2.26 59.1 Test substance storage: At room temperature in the dark Stability under storage conditions: Stable Expiry date: 13 August 2013 Purity/composition correction factor required: No Hygroscopic: No Volatile: No Specific Gravity / Density: 1.17 Stability in water: 1 year
yes Samples for possible analysis were taken from the c ontrol and both replicates of the test concentratio n according to the schedule below. Frequency at t=0 h, t=48 h and t=96 h Volume 1.5 ml Storage Samples were stored in a freezer until anal ysis. Additionally, reserve samples of 1.5 ml were taken from all test solutions for possible analysis. If n ot already used, these samples were stored in a freezer for a maximum of three months after de livery of the draft report, pending on the decision of the sponsor for additional analysis. The samples were stored in the freezer ( ≤ -15°C). Storage stability under these conditions w as demonstrated in WIL Research project 500674. On the day of analysis, samples were defrosted at r oom temperature and analysed. If necessary, the sam ples were diluted with ISO-medium to obtain concentrations within the calibration ran ge. Quantitative analysis was based on the analytical m ethod validated for the test substance in WIL Resea rch project 500674 Analytical method: Instrument: Alliance Separation Module 2695 (Waters , Milford, MA, USA) Detector: Refractive Index Detector 2414 (Waters) Column: Stationary phase: Synergi Hydro-RP 80A Dimensions: 250 mm x 4.6 mm i.d., dp =4 μm Brand: Phenomenex, Torrance, CA, USA Column temperature: 40°C +/- 1°C Injection volume: 50 μl Mobile phase: water containing 0.05M Na2HPO4, 0.05M NaH2PO4 and 0.05M NaNO3 Flow: 1 ml/min RI detection Temperature: 30°C Sensitivity: 4

no The batch of 1-Propanesulfonic acid, 2-hydroxy-3-(2 -propen-1-yloxy)-, sodium salt (1:1) tested was a c lear colourless liquid and completely soluble in test medium at the concentration tested. Preparation of test solutions started with a nomina l concentration of 1000 mg/l, containing 386 mg of the active ingredient (a.i.) Sodium-1- allyloxy-2-hydroxypropane sulphonate. Fifteen minut es of magnetic stirring was applied to accelerate t he dissolving of the test substance in the test medium. The final test concentration was clear and colourless.
Pimephales promelas Species: Fathead minnow (Pimephales promelas, Teleo stei, Cyprinidae) Rafinesque Source: In house culture (Batch FM 13-02) Mean length: 1.9 ± 0.1 cm Mean weight: 0.14 ± 0.04 g Reason for selection: This system has been selected as an internationally accepted species. Feeding: Daily with pelleted fish food (Cyprico Cru mble Excellent (300-500 um), Coppens International bv, Helmond, The Netherlands) Validity of batch: In the batch of fish used for th e test, mortality during the seven days prior to th e start of the test was less than 5%.

static 

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## Limit test Total exposure duration Post exposure observation period 

# Test conditions Hardness Test temperature pH Dissolved oxygen Salinity Nominal and measured concentrations

Details on test conditions

Reference substance (positive control) 

# Results and discussions Effect concentrations

Details on results Results with reference substance (positive control) freshwater yes 96 h

none
180 mg/l expressed as CaCO3 22.5-23.0°C 7.5-7.9 6.8-9.2 mg/l not measured Nominal: 1000 mg/l Analysis of the samples taken at the start of the t est showed that the actual test concentration was i n agreement with nominal (102-103%). This concentration remained stable during the test period (99-101% of initial at the end of the test). Given these results, the effect parameters were based on the nominal exposure concentration. Test duration: 96 hours Test type: Static Test vessels: 6.5 litres, all-glass, containing 5 l itres of test solution Test medium: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3. Number of fish: 7 for the control and 14 for the te st concentration Number of replicates: 1 for the control; 2 for the test concentration, containing 7 fish each Loading: 0.20 g fish/litre, i.e. 7 fish per 5 litre s of test medium Illumination: 16 hours photoperiod daily Aeration: The test media were not aerated during th e test. Feeding: No feeding from 24 hours prior to the test and during the total test period Introduction of fish: Within 40 minutes after prepa ration of the test media from a holding tank with c omparable water quality parameters and pH and temperature differences between test and holdin g tank media of less than 0.5 unit and 0.5°C. Euthanasia: At the end of the test the surviving fi sh were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water. yes pentachlorophenol (PCP)
Duration Endpoint Effect conc. Nominal/Measured Conc. based on Basis for effect Remarks (e.g. 95% CL) 24 h LC50 > 1000 mg/L nominal test mat. (analytically confirmed nominal concentration) mortality LC50: >386 mg active ingredient /L 48 h LC50 > 1000 mg/L nominal test mat. (analytically confirmed nominal concentration) mortality LC50: >386 mg active ingredient /L 72 h LC50 > 1000 mg/L nominal test mat. (analytically confirmed nominal concentration) mortality LC50: >386 mg active ingredient /L 96 h LC50 > 1000 mg/L nominal test mat. (analytically confirmed nominal concentration) mortality LC50: >386 mg active ingredient /L
Behavioural abnormalities: none The 96h-LC50 was 0.20 mg/l based on nominal concent rations, with a 95% confidence interval between 0.1 6 and 0.32 mg/l. This effect was already reached within 72 hours of exposure. No historical data is available on the range of the 96h-LC50 for Fathead minnow. However, this test sh ows that toxicity is similar for Fathead minnow and carp (Teleostei Cyprinidae). For Carp th e 96h-LC50 is generally between 0.10 and 0.46 mg/l based on historical data of reference 

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## Reported statistics and error estimates



# Applicant's summary and conclusion Validity criteria fulfilled Conclusions tests performed approximately every 3 months from A pril 1988 until the end of 2000, and annually since then. No LC50 could be calculated because the test substa nce proved to be non-toxic (LC50 > maximum concentr ation tested).

yes 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-ylo xy)-, sodium salt (1:1) induced no visible effects in fathead minnow at an analytically confirmed nominal concentration of 1000 mg/l. This concentration contained 386 mg of the active ingred ient per litre. Hence, the 96h-LC50 was >1000 mg test substance/l, corresponding to >386 mg a.i./l. 

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