Registration Dossier
Registration Dossier
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EC number: 807-717-5 | CAS number: 295800-70-3
Endpoint summary
Administrative data
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.
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