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Key value for chemical safety assessment

Effects on fertility

Description of key information
 No effects on fertility or adverse effects to the development of offspring were observed in the OECD 421 screening test on read-across target AES fibres.
Additional information

FMMVF fibres are inorganic fibre of very low biological activity. FMMVF fibres do not translocate after intake (ingestion or inhalation). Due to these characteristics it is evaluated that exposure of males and females to FMMVF fibres in a pre-mating period will not affect their fertility. It is assessed that human exposure to FMMVF fibres will not impair human fertility. Consequently, a fertility toxicity study is waived because it is scientifically unjustified.


Short description of key information:
It is assessed that exposure to FMMVF fibres will not impair human fertility. FMMVF fibres shall not be classified as toxic to reproduction according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.

Effects on developmental toxicity

Description of key information
 No effects on fertility or adverse effects to the development of offspring were observed in the OECD 421 screening test on read-across target AES fibres.
Additional information

FMMVF fibres are inorganic fibres of very low biological activity. FMMVF fibres do not translocate after intake (ingestion or inhalation). Due to these characteristics it is evaluated that exposure of the dams will not result in exposure of foetuses.It is assessed that human exposure to FMMVF fibres will not affect the development of human offspring. Consequently, a developmental toxicity study is waived because it is scientifically unjustified.

Justification for classification or non-classification

FMMVF fibres are assessed to possess no toxic properties towards human development and fertility. FMMVF fibres are biosoluble, inorganic fibres of very low biological activity that do not translocate in the body after exposure by inhalation and ingestion. FMMVF fibres shall not be classified as toxic to reproduction according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.

Additional information

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