1,2-benzisothiazol-3(2H)-one 1,1-dioxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Preliminary assessment of the skin sensitizing activity of selected rodent carcinogens using the local lymph node assay

Author:

E.Vicky Warbrick a, Rebecca J. Dearman a, John Ashby a, Peter Schmezer b, Ian Kimber a

Year:

2001

Bibliographic source:

Toxicology 163 (2001) 63–69

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Groups of mice (n=4) were exposed topically on the dorsum of both ears to 25 l of various concentrations of the test chemicals, or to the same volume of the relevant vehicle alone, daily for 3 consecutive days. Five days following initiation of exposure all mice were injected via the tail vein with 250 l of phosphate buffered saline (PBS) containing 20 Ci of [3H] methyl thymidine. Five hours later the mice were sacrificed and the draining auricular lymph nodes excised and pooled for each experimental group. Single cell suspensions of LNC were prepared by mechanical disaggregation through 200-mesh stainless steel gauze. Pooled LNC were washed twice with PBS and precipitated in 5% trichloroacetic acid (TCA) at 4°C overnight. Pellets were then resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase ‘Hisafe 3’, Wallac, Turku, Finland). The incorporation of 3H-TdR was measured by -scintillation counting as disintegrations per minute (dpm) per node for each experimental group. In each case a stimulation index (SI) relative to the concurrent vehicle-treated control was
derived; an SI of 3 or greater being indicative of a chemical possessing the potential to cause contact sensitization

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

1,2-benzisothiazol-3(2H)-one 1,1-dioxide

EC Number:

201-321-0

EC Name:

1,2-benzisothiazol-3(2H)-one 1,1-dioxide

Cas Number:

81-07-2

Molecular formula:

C7H5NO3S

IUPAC Name:

1,2-benzisothiazol-3(2H)-one 1,1-dioxide

Details on test material:

- Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Substance type: Organic
- Physical state: solid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Young adult (8–12 weeks old) CBA/Ca strain female mice (Harlan Seralab, Oxon, UK) were used throughout these studies. Animals were housed four per cage on flushing metal racks. Food (SDS PCD pelleted diet; Special Diets Services, Witham, Essex, UK) and water were available ad libitum.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

DMSO

Induction 2

Concentration / amount:

0, 25, 50 and 75 %

Challenge

Concentration / amount:

0, 25, 50 and 75 %

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

25 µl

No. of animals per dose:

total: 16
0 %: 4 female
25 %: 4 female
50 %: 4 female
70 %: 4 female

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 536 dpm/node to 803 dpm/node

Any other information on results incl. tables

The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.

Executive summary:

The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.