Revision of the opinion on 2,2’-Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol) nano form (S79)

WG on Nano-materials
SCCS members: Q. Chaudhry (chairman), M. Dusinska, W. Lilienblum, Th. Platzek, S. Ch. Rastogi, N. Monteiro-Rivière, U. Bernauer
SCENIHR members: P. H. M. Hoet, K. Rydzynski
External experts: : O. Bussolati, W. H. de Jong, S. H. Doak, Th. Jung, T. Sanner, J. van Engelen (rapporteur)
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/1443/11
Doi: 10.2772/6256
Adopted on: 23 July 2013

Conclusion of the opinion:

Since no appropriate data on genotoxicity of nano form of MBBT were provided, no conclusion on the safety of this substance can be drawn. However regarding systemic effects there seems no concern for the dermal application of nano-sized MBBT.
In addition there are some aspects that need further attention: (i) In the study in rats, clinical effects (pain and vocalization) after dermal application were noted at concentrations of 20% (500mg a.i. /kg bw/d and higher). In the carcinogenicity study, scabs were seen at a dose level of 100 mg a.i./kg/bw/day and higher. It is worthwhile to monitor possible irritation effects via the existing cosmetovigilance programs. (ii) Attention needs to be paid to identification/presence in selected tissues to obtain information on potential bioaccumulation given the physicochemical properties (lipophilicity) of the substance.
The SCCS noted that due to the poor biodegradation potential and the very high octanol-water partition coefficient long term effects or bioaccumulation of MBBT in the environment cannot be excluded, therefore the MBBT is currently classified with R 53/Chronic 4 ("may cause long term effects on the aquatic environment"). The use of MBBT as ingredient in sunscreen products might lead to environmental exposure.

Keywords:

SCCS, scientific opinion, UV-filter, S79, 2,2’-methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), Directive 76/768/EEC, CAS 103597-45-1, EC 403-800-1

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on 2,2’-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), 18 March 2013, revision of 23 July 2013.