SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) – SCCS/1645/22 - Preliminary Version - Archive ouverte HAL Accéder directement au contenu
Ouvrages Année : 2022

SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) – SCCS/1645/22 - Preliminary Version

U. Bernauer
  • Fonction : Auteur
Q. Chaudhry
  • Fonction : Auteur
P.J. Coenraad
  • Fonction : Auteur
M. Dusinska
  • Fonction : Auteur
J. Ezendam
  • Fonction : Auteur
C. L. Galli
  • Fonction : Auteur
E. Panteri
  • Fonction : Auteur
V. Rogiers
  • Fonction : Auteur
M. Stepnik
  • Fonction : Auteur
T. Vanhaecke
  • Fonction : Auteur
S. Wijnhoven
  • Fonction : Auteur
N. Cabaton
  • Fonction : Auteur
A. Koutsodimou
  • Fonction : Auteur
W. Uter
  • Fonction : Auteur
N. Von Goetz
  • Fonction : Auteur

Résumé

SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) – SCCS/1645/22 - Preliminary Version U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz The SCCS adopted this document at its plenary meeting on 24 – 25 October 2022 (47 pages) Mise en ligne le 28 Octobre 2022 https://health.ec.europa.eu/publications/sccs-sodium-bromothymol-blue-c186-cas-no-34722-90-2-ec-no-252-169-7_en Details Publication date : 28 October 2022 Author : Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam (Rapporteur), E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur) Contact:SANTE-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1645/22 Adopted on: 24-25 October 2022 Conclusion of the opinion: 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: - The Applicant used TTC approach to justify the safety of sodium bromothymol blue, whereas the SCCS estimated the SED to exceed the TTC threshold for Cramer class III substances (section 3.5). - 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 low concentrations, it is not acceptable for the substances that are regulated under the EU Cosmetic Regulation. For this, data from NAMs that are scientifically-accepted for the purpose, and/or other acceptable in vivo data on systemic toxicity, are required in an overall weight of evidence for safety. - The Applicant has provided data on two batches of sodium bromothymol blue. The SCCS has concerns about the impurities identified in one of the batches (Guanghua batch), as the levels of these impurities exceed the TTC threshold both individually and collectively. Therefore, the SCCS considers that the presence of these impurities is not safe, and a batch of sodium bromothymol blue matching the impurity profile of Guanghua batch cannot be recommended for use in marketed products. Keywords: SCCS, scientific opinion, sodium bromothymol blue, C186, hair dye, Regulation 1223/2009, CAS No. 34722-90-2, EC No. 252-169-7 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7), preliminary version of 24-25 October 2022, SCCS/1645/22
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Dates et versions

hal-03835267 , version 1 (31-10-2022)

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  • HAL Id : hal-03835267 , version 1

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U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraad, M. Dusinska, et al.. SCCS OPINION on Sodium Bromothymol Blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7) – SCCS/1645/22 - Preliminary Version. Scientific Committee for Consumer Safety (SCCS, EC). , 2022, Scientific Committee for Consumer Safety (SCCS, EC). ⟨hal-03835267⟩
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