- Datum zveřejnění
- 16 prosinec 2014
- Autor /Autorka
- Scientific Committee on Consumer Safety (SCCS)
WG on Fragrance Ingredients
SCCS members:U. Bernauer, Q. Chaudhry, P. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, A. Luch, E. Nielsen, T. Platzek, S. C. Rastogi, Ch. Rousselle, Ja. van Benthem
External experts: A. Bernard A. Giménez-Arnau, T. Vanhaecke
On request from: European Commission
SCCS Number: SCCS/1541/14
Adopted on: 16 December 2014
Conclusion of the opinion:
1. On the basis of currently available information, does the SCCS consider vetiveryl acetate safe for use as fragrance ingredient in cosmetic leave-on and rinse-off type products in a concentration limit(s) according to the ones set up by IFRA as reported above?
In the previous opinion on vetiveryl acetate, the SCCP was of the opinion that the information submitted was inadequate to assess the safe use of the substance. Before further consideration, information such as characterisation of the test substance and clarification on purity and impurities was required (SCCP/0984/06).
Based on the newly submitted studies, the safety of vetiveryl acetate on the market cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market has been reported and as no information has been provided on the composition of the test substances used in the submitted toxicological studies.
Adequate information regarding chemical characterisation and quantification of constituents of ‘vetiveryl acetate’ on the market, including the concentration range of the constituents, is required. Furthermore, documentation and justification is required to allow judgement on whether the test substances used in the submitted toxicological studies can be considered representative for what is considered as ‘vetiveryl acetate’ on the market.
2. Does the SCCS have any further scientific concerns with regard to the use of vetiveryl acetate as fragrance ingredient in cosmetic leave-on and rinse-off type products?
Based on the available data, there is evidence that vetiveryl acetate has skin and eye irritation potential and is a moderate skin sensitiser. Concern was raised in the previous opinion (SCCP/0984/06) that vetiveryl acetate may also have a phototoxic potential; however, based on the submitted data, the photosensitising / photoirritation and phototoxic potential of the test substances cannot be evaluated.
Genotoxicity data are inadequate to exclude the genotoxic/mutagenic effects of vetiveryl acetate which were observed in an Ames test. There was no justification for the use of alpha-tocopherol. New data on genotoxicity of vetiveryl acetate without inclusion of alpha-tocopherol need to be provided.
On the basis of the inadequate data provided, a reliable safety assessment cannot be performed whether vetiveryl acetate on the market is safe for use in cosmetics at the concentration limits proposed by the IFRA. However, due to the major concern of genotoxicity the SCCS considers vetiveryl acetate unsafe as a cosmetic ingredient.
SCCS, scientific opinion, fragrance ingredients, vetiveryl acetate, Regulation 1223/2009, CAS 68-11-1
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on the vetiveryl acetate, SCCS/1541/14, 16 December 2014.