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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Introduction: A study was performed to assess the skin sensitization potential of the test material, Spectrace® MD-810 Marker (Solvent Free) (Lot/Batch No. RWS-2-43; TD No. 04-049), in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:

• OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitization: Local Lymph Node

Assay" (adopted 24 April 2002)

• Method B42 Skin Sensitization (Local Lymph Node Assay) of Commission Directive

2004/73/EC

Methods: Following a preliminary screening test, three groups, each of five animals, were treated with 50 μl (25 μl per ear) of the test material as a suspension in acetone/olive oil 4:1 at concentrations of 2.5%, 5% or 10% w/w. A further group of five animals was treated with acetone/olive oil 4:1 alone.

Results. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows: Concentration (% w/w) in acetone/olive oil 4:1 Stimulation Index

 

Concentration (% w/w)

in acetone/olive oil 4:1

Stimulation Index

Result

2.5

3.39

Positive

5

4.03

Positive

10

2.59

Negative

Conclusion: Under the conditions of the test, the test material, Spectrace® MD-810 Marker (Solvent

Free), was a sensitiser.


Migrated from Short description of key information:
Under the conditions of the OECD guideline 429 LLNA test, the test material, Spectrace TM MD-810 Marker (Solvent Free), was a sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Under the conditions of the OECD guideline 429 LLNA test, the test material, Spectrace TM MD-810 Marker (Solvent Free), was a sensitiser.