Bismuth citrate

WG on Hair Dyes
SCCS members:M. Dusinska, D. Gawkrodger, W. Lilienblum (rapporteur), A. Luch, M. Metzler, E. Nielsen, T. Platzek (chairman), S.C. Rastogi, C. Rousselle, J. van Benthem
External experts: M. Pilar Vinardell, I. White
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1499/12
Doi: 10.2772/74214
Adopted on: 12 December 2013

Conclusion of the opinion:

From the data provided by the applicant, SCCS cannot assess the safety of bismuth citrate. Following information is required to evaluate the safety of bismuth citrate. A complete and adequate physico-chemical characterisation of Bismuth citrate is needed. Skin and eye irritation studies are required at the concentration of 2% as applied for by the applicant. A local lymph node assay (LLNA) in mice was claimed to be negative when using 10 to 50% bismuth citrate dissolved in DMSO. Clarification regarding conflicting information on the solubility of Bismuth citrate in DMSO is required before the test can be accepted as valid. The mutagenicity of bismuth citrate can presently not be assessed given the studies provided. A complete set of in vitro studies according to the current Notes of Guidance is required.

Keywords:

SCCS, scientific opinion, bismuth citrate, Regulation 1223/2009, CAS 813-93-4, EC 212-390-1

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on bismuth citrate, 12 December 2013.