Benzoic acid, 2-fluoro-5-(methylsulfonyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 2010 - November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-fluoro-5-methanesulfonylbenzoic acid

EC Number:

689-137-0

Cas Number:

247569-56-8

Molecular formula:

C8 H7 F O4 S

IUPAC Name:

2-fluoro-5-methanesulfonylbenzoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Description white solid
Batch number BS11020465
Purity 99.5%
Date received 18 June 2012
Expiry date 21 May 2013
Storage conditions room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was
estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification
System- Category 5, >2000- 5000 mg/kg bodyweight).

Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item following a single oral administration in the Wistar strain rat. The method was designed to be compatible with the following:

• OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 17 December 2001)

• Method 81 tris Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

Method

A group of three fasted females was treated with the test item at a dose level of 300 mg/kg bodyweight. Based on the results from this dose level further groups of fasted females were treated at a dose level of 2000 mg/kg bodyweight. Dosing was performed sequentially. The test item was administered orally as a solution in dimethyl sulphoxide. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality

There were no deaths.

Clinical Observations

Signs of systemic toxicity noted at a dose level of 2000 mg/kg were hunched posture, noisy respiration, increased salivation and red/brown staining around the snout. There were no signs of systemic toxicity noted at a dose level of 300 mg/kg.

Bodyweight

Animals showed expected gains in bodyweight over the study period except for one animal treated at a dose level of 2000 mg/kg which showed bodyweight loss during the first week but expected gain in bodyweight during the second week.

Necropsy. No abnormalities were noted at necropsy.

Conclusion

The acute oral median lethal dose (LD 50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System- Category 5, >2000- 5000 mg/kg bodyweight).