5-nitrobenzene-1,2-dicarbonitrile

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental started 18th June 2007 and finished 17th July 2007. Study Report date 26th July 2007.

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 and therefore no formal claim of GLP compliance can be made for this study. The analytical purity of the test sample was unknown although expected to be typical of manufacture. The study was reported as a summary report, but is considered an accurate record of the study and its outcome.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

not specified

Principles of method if other than guideline:

The test material was assessed for its skin sensitising potential using the Local Lymph Node Assay in the 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:

5-nitrobenzene-1,2-dicarbonitrile

EC Number:

250-748-9

EC Name:

5-nitrobenzene-1,2-dicarbonitrile

Cas Number:

31643-49-9

Molecular formula:

C8H3N3O2

IUPAC Name:

5-nitrobenzene-1,2-dicarbonitrile

Details on test material:

The following is taken from the test submission form and is not reported in the summary study report:

- Physical state: solid, crystalline
- Analytical purity: unknown
- Lot/batch No.: Grindley's NBZ 6012/22
- Colour: pale yellow

In vivo test system

Test animals

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-20 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.

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: Control (dimethyl formamide): n/a 5% w/w : 2.52 10% w/w: 2.50 25% w/w: 1.75

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Control (dimethyl formamide): 5424.56 (678.07 per node) 5% w/w : 13645.52 (1705.69 per node) 10% w/w: 13542.99 (1692.87 per node) 25% w/w: 7101.85(1183.64* per node) * Dpm/node obtained by dividing the Dpm vlaue by 8 ( total number of lymph nodes due to one mortality)

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:

Introduction

The study was performed to assess the potential of the test material to produce delayed type hypersensitivy in the mouse using Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC.

Method

The study is an indication for use as the first stage in the assessment of skin sensitisation potential. Three groups, each of four animals were treated with 50 ul of the test material ( 25ul per ear) as a solution in dimethyl formamide at concentrations of 5%, 10%,25%.

Results

Simulation indices:

5% w/w : 2.52

10% w/w: 2.50

25% w/w: 1.75

Conclusion

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