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Expert opinion

2-(4-(2-(4-Diethylamino-2-hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)- (4-diethylamino-2-hydroxyphenyl)-methanone (HAA299) as UV filter in sunscreen products

Final Opinion

Details

Publication date
23 September 2014
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, P.J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, A. Luch, E. Nielsen, T. Platzek, S.C. Rastogi (chairman), C. Rousselle, J. van Benthem
External expert: T. Sanner (rapporteur)
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1533/14
Doi: 10.2772/47374
Adopted on: 23 September 2014

Conclusion of the opinion:

This opinion covers the safety evaluation of HAA299 (micronised or non-micronised), which is not composed of nano particles. The opinion does not cover the safety evaluation of HAA299 which is composed of nano particles. The calculation of margin of safety (MoS) is not justified given the low dermal penetration when applied on human skin, and in consideration of the low observed systemic toxicity (NOEL/NOAEL for oral administration of HAA299 to rats is 1000 mg/kg bw/d). The SCCS is of the opinion that the use of non-nano HAA299 (micronised or non-micronised, with median particle size distribution around 134 nm or larger, as measured by FOQELS) at a concentration up to 10% as an UV-filter in cosmetic products, does not pose a risk of systemic toxicity in humans. The results of genotoxicity testing were negative in vitro as well as in vivo but exposure of target cells was not proven. However, in light of the low bioavailability, the mutagenicity risk for the consumer is considered negligible. This opinion does not apply to inhalation exposure of HAA299 since no information on chronic or sub-chronic toxicity after inhalation is provided. This opinion is based on the currently available scientific evidence, which shows an overall very low or lack of dermal absorption of HAA299 in human skin. If any new evidence emerges in the future to show that HAA299 used as UV-filter in cosmetic products can penetrate human skin (healthy, compromised, sunburnt or damaged skin) to reach viable cells, then the SCCS may consider revising this assessment.

Keywords:

SCCS, scientific opinion, cosmetic ingredients, UV filter, 2-(4-(2-(4-Diethylamino-2-hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)-(4-diethylamino-2-hydroxyphenyl)-methanone, HAA299, Regulation 1223/2009, CAS 75980-60-8 , EC 485-100-6

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of 2-(4-(2-(4-Diethylamino-2-hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)- (4-diethylamino-2-hydroxyphenyl)-methanone, HAA299 as UV filter in sunscreen products, 18 June 2014, SCCS/1533/14, revision of 23 September 2014.

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sccs_o_159.pdf
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