Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The registered substance, Corsair Clear #34, was tested for skin sensitizing properties using the LLNA study method at final concentrations of 10%, 25% and 50%. A positive response was observed at a substance concentration of 50% only, with EC3 of 28.7%. From the results of this study it was concluded that Corsair Clear #34 is considered to have skin sensitizing property when presented at and above a concentration of 28.7%.

The registered substance will not be marketed as substance as such, but will enter the EU market as a component of a preparation: the substance is formulated as a component of a solid ink stick with a maximum concentration of 15%. This maximal concentration of Corsair Clear #34 in the ink stick is well below the limit value of 28.7% for dermal sensitization. To substantiate the non-sensitizing properties of the ink sticks, additional testing was performed with extracts of the ink stick containing the maximum amount (15%) of Corsair Clear #34. These studies are included in section 7.4.1 of the IUCLID5 as supporting studies, and results from these studies will be incorporated in the risk assessment.

Two independent LLNA studies using the ink stick with the maximum concentration of Corsair Clear #34 were conducted.

The first study was performed with Phaser 8560 Yellow Ink, a solid block containing 15% Corsair Clear #34. Toluene/Olive oil (2:1 v/v) was used as vehicle. In this study, a maximum concentration of 25% of the ink stick (an equivalent of 3.75% Corsair Clear #34) was tested, based on the maximum attainable concentration of ink stick in vehicle. The SI values obtained were well below 3, the cut-off point for positive response for skin sensitizing properties in the LLNA study.

A second LLNA study was performed with dimethylformamide (DMF) extracts of the same solid ink stick Phaser 8560 Yellow Ink using the test guidelines available for insoluble materials such as medical devices (ISO 10993-10). The ink stick (trimmed and grounded to coarse powder) was extracted in DMF with a continuous mixing for 72 hours, at 70°C. The extraction efficiency of Corsair Clear #34 was determined to be 100%.The final extracts at concentrations of 25, 50 and 100% were investigated in the LLNA study. The SI values obtained were well below 3 for all concentrations tested, indicating that Corsair Clear #34 at the maximum amount indicated in the formulation of ink sticks does not show any skin sensitizing properties.

The calculated limit value for skin sensitizing properties of Corsair Clear #34 is 28.7%, whereas the maximum concentration of Corsair Clear #34 formulated in the ink sticks is 15%. For risk assessment purposes, as

only ink sticks are imported into the EU, it is appropriate that only the ink stick is considered relevant for assessing the skin sensitization risk to end users.

 


Migrated from Short description of key information:
Information on substance:
LLNA with Corsair Clear #34. Result: a skin sensitizer with EC3 = 28.7%

Information on substance as marketed in EU, and to be considered for CSA/CSR:
LLNA with preparation Phaser 8560 Yellow Ink stick (containing 15% Corsair Clear #34). Result: not a skin sensitizer, but maximum tested concentration of the preparation was 25% (due to solubility limits); equivalent to only 3.75% Corsair Clear #34.
LLNA with dimethylformamide (DMF) extracts of Phaser 8560 Yellow Ink stick following the test guidelines for medical devices (ISO 10993-10). Result: not a skin sensitizer at 25. 50 and 100% extract concentrations (the DMF extraction method was further shown to be 100% efficient for Corsair Clear #34).

Justification for classification or non-classification

Based on the results of the LLNA study with extracts of the ink stick, it can be concluded that the Corsair Clear #34-containing ink sticks have no skin sensitizing potential. However, the substance itself is classified as a skin sensitizer Category 1 (H317) or R43.