“Your file should be reviewed”, this is what the SCCS roughly said to the applicant for the use of bismuth citrate in hair dyes. It is not sufficient as such to assess the safety of this substance. However, experts have confirmed their previous conclusions regarding Acid Black 1 on the one hand, and Ethyl lauroyl arginate HCl on the other, for which they have validated the use as a preservative in mouthwash.
Bismuth citrate
The chemical Bismuth Citrate (CAS: 813-93-4) is a new substance in connection with the hair dye strategy.
See article “
Fragrances and hair dyes: 5 requests for the Opinion of the SCCS
” for exhaustive background information.
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.
• See the full text of SCCS (Scientific Committee on Consumer Safety), Opinion on bismuth citrate , 12 December 2013
Acid Black 1
The Opinion on Acid Black 1 had …
