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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 July 2013-31 July 2013

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:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

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:

CAS number: 247569-56-8
Batch: 270002C
Purity: 99.86%
Retest date: 20 February 2014
Storage Conditions: room temperature in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

other: Dimethyl formamide

Induction 2

Concentration / amount:

50 %w/w in dimethyl formamide

Challenge

Concentration / amount:

50 %w/w in dimethyl formamide

No. of animals per dose:

1 mouse

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

10, 20 and 50 %w/w in dimethyl formamide

No. of animals per dose:

4 mice per dose

Results and discussion

Any other information on results incl. tables

Preliminary Screening Test

Clinical observations, body weight and mortality data are given in Table 1 and local skin

irritation is given in Table 2. The ear thickness measurements and mean ear thickness changes are

given in Table 3.

No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to

or greater than 25% increase in mean ear thickness were noted.

Based on this information the dose levels selected for the main test were 50%, 25% or 10% w/w in

dimethyl formamide.

Main Test

Estimation of the Proliferative Response of Lymph Node Cells

The radioactive disintegrations per minute per lymph node and the stimulation index are given in Table 4.

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group

divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (% w/w) in Stimulation Index              Result

dimethyl formamide

10 1.19 Negative

25 1.88 Negative

50 2.23 Negative

Clinical Observations and Mortality Data

Individual clinical observations and mortality data for test and control animals are given in Table 5.

There were no deaths. No signs of systemic toxicity were noted in the test or control animals

during the test.

Body Weight

Individual body weights and body weight change for test and control animals are given in

Table 6.

Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in

the corresponding control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

2-Fluoro-5-(methylsulfonyl) benzoic acid (CAS Nr. 247569-56-8) was considered to be a non­sensitizer under the conditions of the test (according to OECD guideline 429).

Executive summary:

Introduction

A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

Methods

Following a preliminary screening test in which no clinical signs of toxicity were noted at a

concentration of 50% w/w, this concentration was selected as the highest dose investigated in the

main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50

microL (25 microL per ear) of the test item as a solution in dimethyl formamide at concentrations of

50%, 25% or 10% w/w. A further group of four animals was treated with dimethyl

formamide alone.

Results

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group

divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (% w/w) in Stimulation Index                 Result           

dimethyl formamide

10                                                 1.19                             Negative

25                                                 1.88 Negative

50                                                 2.23 Negative

Conclusion

2-Fluoro-5-(methylsulfonyl) benzoic acid (CAS Nr. 247569-56-8) was considered to be a non­

sensitizer under the conditions of the test (according to OECD guideline 429).