Propan-2-yl N-[(S)-(pentafluorophenoxy)(phenoxy) phosphoryl]-L-alaninate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 November 2012-11 January 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Propan-2-yl N-[(S)-(pentafluorophenoxy)(phenoxy)-phosphoryl]-L-alanine

EC Number:

695-076-0

Cas Number:

1334513-02-8

Molecular formula:

C18H17F5NO5P

IUPAC Name:

Propan-2-yl N-[(S)-(pentafluorophenoxy)(phenoxy)-phosphoryl]-L-alanine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item
- Identification: GS-606962
- Description: White powder
- Substance type: organic
- Lot/batch No.: PSI-172(2)-1-1-12001
- Storage condition of test material: room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.13 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

other: 100% v/v saturated solution

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.13 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

other: 100% v/v saturated solution

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the time-weighted mean measured test concentration of the test media, the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss) gave a 96-Hour LC50 value greater than 0.13 mg/L. The No Observed Effect Concentration was 0.13 mg/L.

Executive summary:

Introduction

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 2013, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Methods

Pre-study solubility work indicated that it was not possible to obtain a testable solution of the test item using traditional methods of dispersal, e.g. ultrasonication and high shear mixing.

A pre-study media preparation trial indicated that a dissolved test item concentration of approximately 0.17 mg/L could be obtained from a saturated solution method of preparation indicating this to be the limit of water solubility of the test item under test conditions.

Following a preliminary range-finding test, seven fish were exposed to an aqueous solution of the test item at a single nominal concentration of 100% v/v saturated solution for a period of 96 hours at a temperature of 13°C to 15°C under semi-static test conditions. The test item solution was prepared by stirring an excess (50 mg/L) of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 µm Sartorius Sartopore filter, first approximate 2 liters discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item. The number of mortalities and any sub-lethal effects of exposure and then daily throughout the test until termination after 96 hours.

Results

Analysis of the freshly prepared 100% v/v saturated solution test concentration at 0 and 72 hours ahowed measured test concentrations of 0.22 and 0.15 mg/L respectively. Analysis of the old or expired media at 24 and 96 hours showed measured concentrations had declined to 0.090 and 0.083 mg/L respectively.

Given this decline in measured test concentrations it was considered justifiable to base the results on the time-weighted mean measured test concentrations of the test media to give a "worst case" analysis of the data.

The 96 -Hour LC₅₀ based on the time-weighted mean measured test concentration was greater than 0.13 mg/L. The No Observed Effect Concentration was 0.13 mg/L.

This study showed that there were no toxic effects of the test item at the limit of solubility.