### Endpoint study record: Acute toxicity: oral 500679

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# Endpoint study record: Acute toxicity: oral 500679
UUID IUC5-e5591fb9-4d1c-41a9-9609-eb865cd12b51 Dossier UUID 0 Author DOC / WIL Research Europe B.V./ 's-Hertogenbosch / Netherlands Date 2013-08-08 09:08:23 CEST Remarks 

# Administrative Data [] Purpose flag key study; robust study summary Data waiving Justification for data waiving Study result type experimental result Study period 17 January - 07 February 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 WIL Research Europe B.V. 2013 Assessment of acute oral toxicity with 1- Propanesulfonic acid, 2-hydroxy-3-(2- propen-1-yloxy)-, sodium salt (1:1) in the rat (Up and Down procedure). WIL Research Europe B.V., Hambakenwetering7, 5231 DD, ‘sHertogenbosch, The Netherlands 500679 Society of Chemical Manufacturers and Affiliates 1850 M Street, NW Suite 700 WASHINGTON, DC 20036 USA 2013- 04-04



### Data access

Data protection claimed
yes 

### Cross-reference to same study


# Materials and methods Test type
acute toxic class method 

### Limit test

no 

### Test guideline

Qualifier Guideline Deviations according to OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure) no

### Endpoint study record: Acute toxicity: oral 500679

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... dows/Temporary Internet Files/Content.Outlook/6RSURWTF/204240_ 500679_Society of chemical manufacturers_UDM hut.html [9/12/2013 2:57:17 PM] according to EPA OPPTS 870.1100 (Acute Oral Toxicity) no 

### Principles of method if other than guideline

GLP compliance
yes 

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

### Test material identity
Identifier Identity
common name 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) 

### Test material form other: Clear colourless liquid 

### Details on test material - Identification: 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) - Synonyms: COPS_1 or CS-AHPS - Substance type: Clear colourless liquid - Physical state: liquid - Lot/batch No.: 12E1101 - Expiration date of the lot/batch: 13 August 2013 - Storage condition of test material: At room temperature in the dark - Purity/composition correction factor required: No - Hygroscopic: No - Volatile: No - Specific Gravity / Density: 1.17 - pH: 7 at concentration of 40.9% - Stability at higher temperatures: Yes, maximum temperature: 80°C, maximum duration: 1 hour 

### Confidential details on test material
None 

## Test animals Species
rat 

### Strain other: Wistar (Han) 

### Sex
female 

### Details on test animals and environmental conditions - Source: Charles River Deutschland, Sulzfeld, Germany. - Age at study initiation: Young adult animals (approx. 9-10 weeks old) - Weight at study initiation: Body weight variation was within +/- 20% of the sex mean. - Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum. - Housing: Individually housed in labeled Makrolon cages. - Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). - Water: Free access to tap water. - Acclimation period: At least 5 days ENVIRONMENTAL CONDITIONS Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.

### Endpoint study record: Acute toxicity: oral 500679

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... dows/Temporary Internet Files/Content.Outlook/6RSURWTF/204240_ 500679_Society of chemical manufacturers_UDM hut.html [9/12/2013 2:57:17 PM] IN-LIFE DATES: From: 17 January - 07 February 2013 

## Administration / exposure Route of administration oral: gavage 

### Vehicle unchanged (no vehicle) 

### Details on oral exposure GAVAGE METHOD: plastic feeding tubes. Frequency: single dosage, on Day 1. MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (1.71mL/kg) body weight. DOSAGE PREPARATION: The test substance was dosed undiluted as delivered by the sponsor. No correction was made for the purity of the test substance. 

### Doses 2000 mg/kg body weight 

### No. of animals per sex per dose
5 

### Control animals

no 

### Details on study design The toxicity of the test substance was assessed by stepwise treatment of five females. The first animal was treated at a dose level of 2000 mg/kg. The absence or presence of mortality at one step determined the next step, based on the test procedure defined in the guidelines. Based on the results of this first animal, four additional animals were dosed at 2000 mg/kg. - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Mortality/Viability: Twice daily. Body weights: Days 1 (pre-administration), 8 and 15. Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. - Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded. - Other examinations performed: none. 

### Statistics No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value). 

### Any other information on materials and methods incl. tables 

# Results and discussions **Preliminary study (if fixed dose study)**

Effect levels

Sex Endpoint Effect level Based on 95% CL Remarks female LD50 > 2000 mg/kg bw test mat. 

### Mortality No mortality occurred after dosing 5 females at 2000 mg/kg. 

### Clinical signs

### Endpoint study record: Acute toxicity: oral 500679

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... dows/Temporary Internet Files/Content.Outlook/6RSURWTF/204240_ 500679_Society of chemical manufacturers_UDM hut.html [9/12/2013 2:57:17 PM] Hunched posture and/or piloerection were seen in two females. 

### Body weight The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. 

### Gross pathology No abnormalities were found at macroscopic post mortem examination of the animals. 

### Other findings

Any other information on results incl. tables 

# Overall remarks, attachments Remarks on results including tables and figures Attached background material Attached full study report Illustration (picture/graph) 

# Applicant's summary and conclusion Interpretation of results

Criteria used for interpretation of results
EU 

### Conclusions The oral LD50 value of 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, 1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1) does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. 

### Executive summary Cross-reference to other study