Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Testing of lead bis(tetrafluoroborate) is considered to be justified, since the substance is classified as corrosive by worst case based on the pH of <2 in aqueous solution. Nevertheless, animal testing for sensitisation potential is not scientifically justifiable as it would not provide any further information considered being relevant for human risk assessment.

However, animal and human data on various lead substances exist which stated that neither skin nor respiratory sensitisation are observed. Therefore, read across from lead compounds (in special from water soluble substances) and tetrafluoroborate salts is considered to be justified. The toxicity of lead bis(tetrafluoroborate) may reasonably be considered to be determined by the availability of lead2+and tetrafluoroborate-. Aa a first surrogate for bioavailability, the water solubility may be used. Lead chloride is water soluble up to 10 g/L at 20°C, tetrafluoroborate salts (e.g potassium tetrafluoroborate, sodium tetrafluoroborate and triethylmethylammonium tetrafluoroborate) from 1.3 g/L at 20°C (KBF4) up to 2000 g/L at 20°C (TEMABF4). The water solubility of lead bis(tetrafluoroborate) is > 500 g/L at 20°C. Therefore, such read-across is considered to be feasible without restrictions.

In conclusion, given the lack of sensitising properties of lead compounds in general and of tetrafluoroborate salts especially, lead compounds and tetrafluoroborate salts do not appear to pose any risk of sensitisation, and therefore no classification for these endpoints is indicated.

Justification for classification or non-classification

Classification and labelling of lead bis(tetrafluoroborate) is considered not to be justified, due to the reasons given above.