title: Special-purpose fiber type 475--toxicological assessment.
abstract: Type 475 special-purpose glass fiber is rather unique among the family of synthetic mineral fibers. It is used not for insulation but for "high-end" filtration products designed for high and ultra-high purity filtration of air and liquids. The designation for these types of filters varies with country and includes HEPA, ULPA, EU 10-13, EN1822, and S3. In its evaluation, type 475 has been grouped together with E-glass another special-purpose fibre often with little distinction made in terms of its chemistry and corresponding toxicological response. The detailed review of the available toxicology data on type 475 glass fibers clearly shows that following inhalation of this fiber even at relatively high doses, which likely exceed that at which lung overload in the rat is known to occur, type 475 glass fibers are not fibrogenic and do not cause tumors. These data clearly show an important differentiation in potency between type 475 glass fibers and E-glass and support treating these two types of fibers independently and not equating them though the term "special-purpose fibers." Analysis of the intraperitoneal studies taking into account fibre dimensions shows that at 109 fibers injected, there was a 0.3 tumor incidence. While these studies indicate according to the European Commission (EC) classification criteria that 475 should not be fully exonerated as a carcinogen, the results of the inhalation study fully support classification in category 3. The IP results are more difficult to interpret, however, the IP study itself provides no toxicological basis for determining what range of dose-response should correspond to EU category 3 or 2. Following the EC classification criteria, the toxicological data clearly indicate that 475 fibers are appropriately classified in EC category 3.
authors.affiliation: davidb@itox.ch
authors.forename: D M
authors.initials: DM
authors.lastname: Bernstein
mesh_terms: D000280:Administration, Inhalation; D000818:Animals; D002478:Cells, Cultured; D006224:Cricetinae; D004305:Dose-Response Relationship, Drug; D005062:European Union; D005374:Filtration / Q000295:instrumentation; D005898:Glass / Q000737:chemistry; D007274:Injections, Intraperitoneal; D019016:Mineral Fibers / Q000633:toxicity*; D051381:Rats; D018570:Risk Assessment; D018675:Toxicity Tests
chemical_list: D019016:Mineral Fibers; C009753:fiberglass