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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 October 2012-12 November 2012

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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

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
- Name of test material (as cited in study report): GS-606962
- Substance type: organic
- Physical state: white powder
- Lot/batch No.: PSI-172(2)-1-1-12001
- Date received: 09 July 2012
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other:

Duration of treatment / exposure:

Single administration.

Observation period (in vivo):

1 hour and 24, 48 and 72 hours following treatment.
An additional observation was made on Day 7.

Number of animals or in vitro replicates:

three animals

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Max. score:

13.7

Remarks on result:

other: modified Kay and Calandra classification system

Applicant's summary and conclusion

Interpretation of results:

other: mild irritant

Remarks:

Criteria used for interpretation of results: other: modified Kay and Calandra classification system.

Conclusions:

The test item produced a maximum group mean score of 13.7 and was classified as a mild irritant (Class 4 on a 1to 8 scale) to the rabbit eye according to a modified Kay and Calandra classificati

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)

- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

Results

A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 72 -hour observation and two treated eyes appeared normal at the 7 -Day observation.

Conclusion

The test item produced a maximum group mean score of 13.7 and was classified as a mild irritant (Class 4 on a 1to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.