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.,

Hambakenwetering

7, 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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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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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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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