sodium 3-[(3,4-dicyanophenyl)thio]propane-1-sulfonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-10-31 to 2006-11-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted in a facility operating to GLP within the UK national GLP monitoring programme, but the study report was not audited by the QA unit at the facility. No formal claim of GLP compliance can be made for this study however the report is an accurate record of the study and its outcome.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2007

Materials and methods

Principles of method if other than guideline:

Test Guideline not specified. The test material was assessed for its skin sensitising potential using the Local Lymph Node Assay in the CBA/Ca strain of mouse. The test is designed to assess the skin sensitising potential (delayed type hypersensitivity) of the test material following topical application to the dorsal surface of the ear. Primary lymphocyte proliferation is assessed during the sensitising (induction) phase of the response. The assay determines the level of lymphocyte proliferation in lymph nodes draining the application site of the test material. Determination of lymphocyte proliferation is quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation index).

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

S193115 batch Z5849/54

IUPAC Name:

S193115 batch Z5849/54

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FJD-01A (S193115)
- Analytical purity: 96.7%
- Lot/batch No.: Z5849/54
The test material is from a different manufacture batch to the substance defined in section 1 but is the equivalent material.

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 17-21 g

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

10%, 25% and 50% w/w of test material

No. of animals per dose:

4 animals per test concentration and 4 control animals

Details on study design:

RANGE FINDING TESTS:
No signs of systemic toxicity at a test conc. of 50% w/w in the preliminary sighting study.

MAIN STUDY
- Criteria used to consider a positive response: Primary lymphocyte proliferation is assessed by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells.The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes.

TREATMENT PREPARATION AND ADMINISTRATION: Topical application of the test solution to the dorsal surface of the ear

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Control (dimethyl formamide): n/a 10% w/w : 1.52 25% w/w: 2.99 50% w/w: 2.78

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Control (dimethyl formamide): 4203.37 (525.42 per node) 10% w/w : 6377.23 (797.15 per node) 25% w/w: 12581.42 (1572.68 per node) 50% w/w: 11676.66 (1459.58 per node)

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

This study was undertaken to assess the skin sensitising potential of the test material using the Local Lymph Node Assay in the mouse. The test was designed to assess the skin sensitising potential of the test material following topical application to the dorsal surface of the ear. Primary lymphocyte proliferation was assessed during the sensitising (induction) phase of the response. Each of the test concentrations (10, 25, 50% w/w) had a negative result in the study. The test material was considered to be a non-sensitiser under the conditions of the test.