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Toxicological information

Carcinogenicity

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Administrative data

Description of key information

The carcinogenic potential of E-glass microfibre has been tested experimentally in two chronic toxicity inhalation studies in rats. In both studies E-glass microfibre was found to be tumourigenic at high exposure concentrations. E-glass microfibre induced carcinomas, adenomas and mesotheliomas as well as severe fibrosis in the lungs of male rats exposed by inhalation to E-glass microfibre for 12 months (7 h/day, 5 days/week for 12 months). 
E-glass microfibre is proposed to be classified Carc. Cat. 2; R49: May cause cancer by inhalation.

Key value for chemical safety assessment

Justification for classification or non-classification

Proposed classification by the registrant is Carc. Cat. 2; R49: May cause cancer by inhalation.

Additional information

The potential of E-glass micofibre (i.e. code 104E fibres) to induce lung fibrosis and cancer/neoplastic changes was investigated experimentally by long-term whole body exposure of male rats to inhalation of aerosols of E-glass microfibre (1000 WHO fibres/ml) for 7 hours a day, 5 days a week and up to 12 months, followed by a recovery period of up to 12 months (Searl et al 1999; Cullen et al 2000).

The methods used in the studies were similar to those described in EC guideline (ECB/TM/17(97) rev. 2) with some deviations.

The studies showed that E-glass microfibre induced fibrosis, carcinomas, adenomas and mesotheliomas in the rat. It is noted that an ILSI working group recently stated (ILSI, 2005) that all fibres that have caused cancer in animals via inhalation have also caused fibrosis at an earlier time point, that is after 3-month exposure. However, there have been fibres that have caused fibrosis but not cancer.

Carcinogenicity: via inhalation route (target organ): respiratory: lung