Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

For the purposes of the registration of K2TaF7, under REACH, a justification for the omission of in vivo studies is presented in Section 13 (Assessment Reports). This document provides a waiver for the conduct of in vivo studies with K2TaF7, and proposes a basis and rationale for the Human Health risk assessment, other than through the establishment of DNELs.

Aqueous solutions of K2TaF7 at physiological temperatures yield the complex ion TaF72- , a Lewis acid which imparts a pH of 2 to the solution, which is capable of causing serious damage to eyes (when K2TaF7 is introduced into rabbit eyes). In gastric juice (0.1 N HCl) the presence of hydrochloric acid promotes the degradation of K2TaF7 to Ta2O5, KF and HF. Ta2O5, is biologically inert and considered toxicologically not relevant for Human health risk assessment purposes in this scenario. KF and HF are considered responsible for acute corrosive portal-of-entry effects seen in the GIT in rats gavaged with K2TaF7. The effects after repeat dosing in a range finding study showed effects that were reasonably attributable to liberated fluoride, such that all further in vivo testing could be waived on the basis of corrosivity. At sub-corrosive concentrations in vivo, the fluoride ion remains toxicologically relevant and exposure to the fluoride ion from occupational exposures to K2TaF7 should be considered against the European upper tolerable intake level for fluoride.


Short description of key information:
No study conducted.

Effects on developmental toxicity

Description of key information
No study conducted.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

For the purposes of the registration of K2TaF7, under REACH, a justification for the omission of in vivo studies is presented in Section 13 (Assessment Reports). This document provides a waiver for the conduct of in vivo studies with K2TaF7, and proposes a basis and rationale for the Human Health risk assessment, other than through the establishment of DNELs.

Aqueous solutions of K2TaF7 at physiological temperatures yield the complex ion TaF72- , a Lewis acid which imparts a pH of 2 to the solution, which is capable of causing serious damage to eyes (when K2TaF7 is introduced into rabbit eyes). In gastric juice (0.1 N HCl) the presence of hydrochloric acid promotes the degradation of K2TaF7 to Ta2O5, KF and HF. Ta2O5, is biologically inert and considered toxicologically not relevant for Human health risk assessment purposes in this scenario. KF and HF are considered responsible for acute corrosive portal-of-entry effects seen in the GIT in rats gavaged with K2TaF7. The effects after repeat dosing in a range finding study showed effects that were reasonably attributable to liberated fluoride, such that all further in vivo testing could be waived on the basis of corrosivity. At sub-corrosive concentrations in vivo, the fluoride ion remains toxicologically relevant and exposure to the fluoride ion from occupational exposures to K2TaF7 should be considered against the European upper tolerable intake level for fluoride.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for reproductive or developmental toxicity.