sodium 3-[(2,3-dicyanophenyl)thio]propane-1-sulfonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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. This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

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:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

see Confidential details on test material section

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 kg

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)

Any other information on results incl. tables

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Executive summary:

This study was undertaken to assess the skin sensitising potential of the source test material using the Local Lymph Node Assay in the mouse. The test was designed to assess the skin sensitising potential of the source 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 source test material was considered to be a non-sensitiser under the conditions of the test.

This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.