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.
Authors
Directorate-General for Health and Food Safety, European Commission
- Catalogue number
- EW-AQ-24-004-EN-N
- Citation
- European Commission, Directorate-General for Health and Food Safety, Opinion on sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) , Publications Office of the European Union, 2024, https://data.europa.eu/doi/10.2875/143059
- DOI
- https://data.europa.eu/doi/10.2875/143059
- ISBN
- 978-92-68-19387-7
- ISSN
- 1831-4767
- Pages
- 47
- Published in
- Belgium
- Themes
- Pharmaceutical and cosmetics industry , Consumers' health
