Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.