Benzoic acid, 2-chloro-3-methyl-4-(methylsulfonyl)-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according EU/OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

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-chloro-4-methanesulfonyl-3-methylbenzoic acid

EC Number:

600-786-0

Cas Number:

106904-09-0

Molecular formula:

C9H9ClO4S

IUPAC Name:

2-chloro-4-methanesulfonyl-3-methylbenzoic acid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Remarks:

(DMSO)

Concentration:

0 (vehicle control), 10, 25 and 50%.

No. of animals per dose:

5 mice per group

Results and discussion

Any other information on results incl. tables

The aim of this study was to assess the potential of the test substance, an industrial intermediate compound containing the active ingredient of 99.6% w/w, to induce skin sensitization using the murine Local Lymph Node Assay.

 

Twenty female CBA/J mice were allocated to 4 groups of five animals each:

- three groups received the test substance at a concentration of 10, 25 or 50% in vehicle,

- one control group received the vehicle, Dimethylsulfoxide (DMSO).

 

The test substance and the vehicle were applied on external surfaces of both ear (25 µllear) for three consecutive days (Days 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated thymidine and the stimulation indices were calculated.

 

No mortality and no clinical signs were observed during the study. No cutaneous reactions were observed in the vehicle, reference control or treated groups. The stimulation indices of the test substance were 1.1, 1.0 and 0.8 at treatment concentrations of 10, 25 and 50%, respectively.

 

The test substance was found to be non-sensitizing in the Local Lymph Node Assay at all concentrations tested.

Applicant's summary and conclusion

Interpretation of results:

other: not irritant or sensitising

Executive summary:

There were no confounding effects of irritation or toxicity, so the proliferation values are considered to reflect the sensitization effects of the test substance.

 

The test substance was found to be non-sensitizing in the Local Lymph Node Assay at all the concentrations tested.