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Expert opinion

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

Final Opinion

Details

Publication date
25 June 2015
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Nanomaterials in Cosmetic Products
SCCS members:U. Bernauer, Q. Chaudhry, M. Dusinska, W. Lilienblum, T. Platzek, S. C. Rastogi, Ja. van Benthem
SCENIHR members:P. H. M. Hoet, K. Rydzynski
External experts: A. Bernard, O. Bussolati, N. von Goetz, S. H. Doak, T. Jung
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1546/15
Adopted on: 25 June 2015

Conclusion of the opinion:

1. In light of the new data provided, does the SCCS consider Methylene bis-benzotriazolyl tetramethylbutylphenol (CAS No 103597-45-1) safe when used in cosmetic products in its nano forms under the current use conditions up to a maximum of 10%?

The calculation for margin of safety in this Opinion is based on a 39-week dermal toxicity study in the mini-pig, as no repeated dose toxicity study with the nano-sized material is available in rats. Also, dermal penetration data are not available for mini-pig skin. The SCCS has based this Opinion on the overall weight of evidence that suggests a very low absorption of MBBT in human intact skin and artificially damaged skin (top skin layers removed), and the lack of adverse effects in mini-pigs up to the highest dose tested (1000mg a.i./kg bw/day) over 39 weeks. These together indicate that dermal application of nano-sized MBBT with regard to systemic effects is not a safety concern. The SCCS has therefore concluded that the use of MBBT [2,2’-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)] in nano-structured form with the following characteristics as a UV-filter at a concentration up to 10% in dermally applied cosmetic products is considered to not pose a risk of adverse effects in humans after application on healthy, intact skin and also damaged skin.

- The material has a purity of ≥98.5% with the isomer faction not exceeding 1.5%, and the impurity profile not significantly different from that indicated in section 3.1.5.

- The material has a median particle size (d0.5) of 120 nm or larger in terms of mass distribution, and/or 60 nm or larger in terms of number size distribution (by laser diffraction).

- The material complies with other physicochemical specifications of the evaluated material as listed under section 3.1 of this opinion in terms of chemical identity, physical form, chemical composition, solubility, zeta potential, etc.

- Compared to human intact skin or artificially damaged skin (top skin layers removed), the Mean amount penetrating through intact rat skin was considerably higher (5.922 % of the applied amount versus 0.048 % in intact human skin and 0.35 % in artificially damaged human skin). The higher value for rat skin was used in MOS calculation as the worst case. Thus, the conservative approach used is considered to also cover the damaged human skin that is devoid of top layers.

In view of the limited available information on inhalation toxicity, which indicates severe inflammatory effects of microfine MBBT in the respiratory tract, caution is warranted against the use of the material in applications that could lead to exposure of the consumer’s lungs by inhalation. This Opinion therefore does not apply to such applications that might lead to exposure of the consumer’s lungs to MBBT nanoparticles by inhalation.

It should also be noted that this Opinion is based on the currently available scientific evidence, which shows an overall very low dermal absorption of MBBT in nano- or larger particle forms. If any new evidence emerges in the future to show that the nano-form of MBBT used in cosmetic products can penetrate skin in any significant amounts to reach viable cells, the SCCS may consider revising this assessment.

2. Does the SCCS have any further scientific concern regard the use of Methylenebis-benzotriazolyl tetramethylbutylphenol in cosmetic products?

The in vitro genotoxicity assessment of MBBT was negative in two different test systems. These tests were appropriately applied and demonstrate that there was no evidence for chromosomal damage or mutagenicity when mammalian cells were exposed to both non-micronised and nano-forms of MBBT. Although these test data are accepted by the SCCS, no experimental data on uptake/internalisation of the particle by cells has been provided.

In addition, the SCCS has the following concerns:

- In the study in rats, clinical effects (pain and vocalisation) 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 cosmetovigilance programs.

- Given the physicochemical properties (high lipophilicity) of the substance, potential bioaccumulation in selected tissues is of concern, especially over long-term use.

This opinion does not address the effects of MBBT on the environment.

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), SCCS/1546/15, 25 March 2015.

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