Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No information specifically for lead bis(tetrafluoroborate) or tetrafluoroborates on toxicity to reproduction was available, as verified in a literature search performed in 2010. However, read across to lead compounds is proposed to be feasible without restriction for risk assessment purposes. Lead compounds which are not specified elsewhere are already legally classified in Annex I of directive 67/548/EEC as “repro. 1A – H360: May damage fertility or the unborn child”. It can reasonably be assumed that this classification is also applicable to this substance, and therefore in accordance to annex VIII of the REACH regulation (EC) 1907/2006, further testing either for effects on fertility or on developmental toxicity are not required.

Summary on studies provided in this dossier for lead compounds which support classification and labelling as "repro. Cat. 1A":

Although a number of studies have been conducted of male reproductive function in workers occupationally exposed to lead, definitive statements regarding the impact of lead upon male reproductive potential are difficult to make. Alterations in semen quality are the most commonly observed effects in the occupational setting and can be documented with precision, but such changes are not synonymous with impacts upon fertility. Natural and extreme variability in semen quality (e.g. sperm count and motility) is evident among fertile individuals and modest impacts upon semen quality(e.g. in blood lead ranges of 50 – 60 µg/dL) would not be expected to have a significant impact upon actual fertility. Higher blood lead levels would have greater impacts upon semen quality – the decrements associated with high blood lead levels would be expected to have an impact upon the fertility of normal, healthy individuals. The dosimetry for impacts upon female fertility is uncertain but appears to entail general systemic toxicity induced at blood lead levels in excess of 70 µg/dL.

Effects on developmental toxicity

Additional information

No information on lead bis(tetrafluoroborate) or a tetrafluoroborate on toxicity to reproduction could be made available during literature search performed in 2010. However, read across to lead compounds is proposed to be sufficient for risk assessment purposes. Nevertheless, lead compounds, which are not specified elsewhere, are already legally classified in Annex I of directive 67/548/EEC as “repro. 1A – H360: May damage fertility or the unborn child”. It can safely be stated that no change in classification would be needed if studies would be initiated/proposed with lead bis(tetrafluoroborate). In conclusion and in accordance to annex VIII of the REACH regulation (EC)1907/2006 no further testing neither on effects on fertility nor on developmental toxicity must be performed.

Justification for classification or non-classification

Lead compounds not otherwise specified in Annex 1 of Directive 67/548/EEC are classified as follows:

                 Repr. Cat. 1; R61 (may cause harm to the unborn child)

                      Repr. Cat. 3; R62 (possible risk of impaired fertility)

Under the CLP this classification is designated as:

Repro. 1A  : (H360FD)

Classification for reproductive toxicity is supported by the experimental data as soon as they could be made available and gain access to other lead data, respectively. Based on this data which are included into this dossier, no change in classification and labelling is expected.