Registration Dossier

Toxicological information

Immunotoxicity

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Administrative data

Description of key information

The in vitro immunological effects of siloxanes, including D5, were investigated using cultured human immune cells (Dow Corning Corporation, 2001). It was found that in the absence of serum, D5 is toxic to peripheral blood mononuclear cells. However, when small amounts of serum or plasma are added, the toxicity is not observed due to lipoprotein content. The study authors therefore concluded that the effects on immune cells systemically are not relevant to humans as there will be sufficient lipoproteins to prevent toxicity. It was speculated that there might be some implications of the toxicity locally in the respiratory mucosa, where concentrations of D5 might become too high compared with lipid availability, thus leading to inflammation or fibrosis. 

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on immunotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on immunotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is one reliable in vitro study relevant to the immunotoxicity of D5 available.

Justification for classification or non-classification

Based on the available data D5 does not require classification for immunotoxicity according to Regulation (EC) 1272/2008.