SCCS opinion on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) - SCCS/1645/22 - Final Version
Résumé
The SCCS concludes the following:
1. In light of the data provided, does the SCCS consider Sodium Bromothymol Blue safe
when used in non-oxidative hair colouring products up to a maximum on-head
concentration of 0.5 %?
Having considered the data provided, the SCCS is of the opinion that the safety of
sodium bromothymol blue cannot be assessed because of the following reasons:
- The Applicant used TTC approach to justify the safety of sodium bromothymol blue,
but the SCCS estimate of the SED indicates that it exceeds the TTC threshold for
Cramer class III substances.
- The use of TTC on its own to justify the safety of the substances that are regulated
under the EU Cosmetic Regulation is not sufficient to waive the information
requirements on essential toxicological endpoints.
2. Does the SCCS have any further scientific concerns with regard to the use of Sodium
Bromothymol Blue in cosmetic products?
While the use of TTC is acceptable to justify the safety of impurities and cosmetic
ingredients that are added to a final product at sufficiently low concentrations, it is not
acceptable on its own for the substances that are regulated under the EU Cosmetic
Regulation. Additional supporting data from NAMs that are scientifically-accepted for
the purpose, and/or other acceptable in vivo data on systemic toxicity, are also
required in an overall weight of evidence to assess safety.
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