Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The biopersistence of the fibres described in this dossier has been found to be below  the limits set in European Regulations

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

These and similar materials are sold as exonerated from carcinogen classification and certificates attesting to their results in biopersistence testing are routinely provided to downstream users, examples of such certificates can be found in section 1.4 analytical information.

These fibres clear rapidly from the lung, they break and the fragments are cleared by the normal physiological means (Moore M, Brown R.C., Pigott G, 2001, Material Properties of MMVF and their time dependant failure in lung environments, Inhalation Toxicology, Vol. 11, pages 1117 - 1149). Thus there is no potential for bio-accumulation and fibre fragments are cleared to the gut and are not available for systemic effects.

 

Full ADME studies have not been carried out on any fibre. Access to the body is determined by respirability a function primarily of fibre diameter and secondarily of length. As the product as sold is a fibrous wool, it cannot be regarded as respirable at all, only fibres released during handling and use become aerosolised and available for inhalation. No studies have demonstrated that fibres as large as these vitreous man made fibres leave the lung and gut and become located elsewhere in the body. Excretion occurs after fibres are attacked by the aqueous environment or by macrophages, processes not normally regarded as metabolism, the damaged fibres fragment and are removed to and then from the gut in faeces