SCIErfflFIC COÍYÖVHTTE'E OM COWSUIVCEÄ ЗАЖТУ

'R«iļH«sl ier a sdfiötffic opaíloa: Submissiën II «n íregraace ysM'frryI acetate -

1, _

Yeîiveryl acetate (CAS n, 62JÕ3-8Ü-Õ/ 84U82-84-S/ 117-98-0) has a long history of widespread use as a woody note m perfumery.

During the Committee oa Cosmetic Products arid Non-Food Producís intended tor the

, -. c ι·'· . ι of 1 • .1 1 ι.-''· ~y

materiais to be included in Агюаех ΠΙ - List of substances which cosmetic products must not contain except subject to :

n0 3CCNř'P/0'i92/0U imal). Subsequently, the list was taken over in the Annexes to Regulation (EC) No 1223/2009. "

of Perfumery Materials which must not form part of Cosmetic rroducts except subject to the restrictions arid conditions iaid down" during the 26th plenary meeting of 9 December 2003 (doc. № SCCNFP/0770/03).

The ingredient vetiveryl acetate was not included in the lists mentioned above but the SCCNFP (doc. № SCCNFP/0770/03) aimed to discuss additional substances for possible inclusion at a later date.

That is by The European Flavour & Fragrance Association.

The Scientific Committee on Consumer Products (SCCP) adopted at its 7th ļ - ., - . - ; , . 'o ОП Vetiveryl acetate (sensitisation only) with the following conclusion;

The SCCP ís of the opinion ¡'hat (he info maž i on submitted ÍS inadequate to assess the safe use of the substance. Before any further consideration, the followmg irfonoaiton is required: '* Characterisation of the test substance; ciantication on purity and impurities; ' Data on sensitisation conforming to modern standards and guidelines; » Appropriate information on ail reievont toaicoiogical endpomts as required to assess the safe use of the substance 'when used, in cosmetic products.

In June 2013 che CommCsion has received an update dossier by the Intematioiia! Fragrance Association (IFTA) on the safety assessment of Vetiveryl acetate. This submission is intended ίο demonstrate the saíety ot the

ingredient when used as fragraiice ingredient in cosmetic leave-on and rinse-off type products, IFRA recommends a safe concentration limit for Vetiveryl acetate when it is used m the specific categories of cosmetic products as developed by the International Fragrance Association (IFRA),

Category 1 (Lip products)

0,07 % Category 6 (Mouthwash, toothpaste)

1,67 %

Category 2 (Deodorants/

0,08 % Category 8 (Make up ¡етоver, Nari

2,00%

Category 3 (Hydroalcohoiic Products for Shaved Skin)

0,35 % rinse-off

conditioner, bar soap)

Hydroalcohoiic Products for Unshaved Skia)

1,04 %

Category 5 Women's facial cream, fecial makeup, hand cream)

0,55 %

A Tsosras of refeoHíCií

1. Cdi the basis of currentiy available information, does the SCCS consider Vetiveryl acetate safe for use as fragrance ingredient m cosmetic leave-on ami rinse-off type products in a concentranon Urmt(s) according the cm es set up by IFRA as reported abo ve 'i'

2. Ones the SCCS have any fio Pie*· scientific ceacems with record io the use of vetiveryl acetate as fragromce oiersdient in cosmetic leave-an and rinse -off type producís?

папате

Dossier on tłie Safety of Vetiveiyi Acetate (CAS iľ/cCA) mCoseaetìc Prodcicts Submission II A7 September dOid

2. • : •' ' ' ·γ : '• : ,1 •

Produces -Submission Я-· update - 1 í june SOU

3, Docuineof ff-RA Standard on Vetiveiyi Acetate,

Vetiveryl acetate

117-98-6 (62563-80-8 168917-34-0 Į 73246-97-6 I 84082-84-8

Į 6-Azulenol, 1,2,3,33,4,5,6,8a-octahydiO-4,8-dìmethyl-2-(methylethylidene)-, acetate 6-Azulenol, I.Ž.S.SaAS.e.Sa-octahydrcMl.S-dimethyl^-Õ-methylethylidene)-, acetate 2-lsopropylidene-4,8-dimethyl-1,2,3,3a,4,5,6,8a-octahydroazulen-6-yl acetate Vetivert acetate, Vetivert acetate (Haiti), Vetyvenyl acetate Vetiverol, acetate

In tal reviews: New Standard rent revision date: 2009

mpiementation date: For new submissions*: August 7, 2009 For existing fragrance compounds*: August 7, 2011

Next review date 2014

' This date applies to the suppiy of fragrance compounds (formulas) only, not to the finished products in the marketplace.

RECOMMENDATION: RESTRICTED I SPECIFICATION

RESTRICTIONS:

Category 1 See Note box (1) 0.07 % Category 7 0.17%

Category 2 0.08 % Category 8 2.00 % Category 3 0.35 % Category 9 5.00 %

Category 4 1.04% Category 10 2.50 %

Category 5 0.55 % Category 11 See Note Box (2)

Category 6 1.67 %

(1) IFRA would recommend that any material used to impart perfume or flavour in products intended for human ingestion should consist of ingredients that are in compliance with appropriate regulations for foods and food flavourings in the countries of planned distribution and, where these are lacking, with the recommendations laid down in the Code of Practice of IOFI (International Organisation of the Flavor Industry -www.iofiorg.org)

(2) Category 11 includes all non-skin contact or incidentai skin contact products. Due to negligible skin contact the concentration of a fragrance ingredient should not exceed the usual concentration of the fragrance compound in the finished product

IFRA Standard - Vetiveryl acetate October 14,2009 1/2

Vetiveryl acetate

Acetylated vetiver oil (Vetiveryl acetate) should only be used as a fragrance ingredient if produced by methods that lead to a reduction in allergenic materials, like the ones outlined below (acetylation methods using acetic anhydride):

• without catalyst, at a temperature not exceeding 120°C. • with ortho phosphoric acid at room temperature. • with sodium acetate in toluene at reflux temperature.

The first two products can be used in their crude form after the usual procedures, but may be further purified. In the last case, distillation is necessary. Another method accepted is an enzymatic acetylation process. This recommendation is based on test results of RIFM with samples prepared according to different acetylation methods (private communication to IFRA),

None to consider (see also the note on contributions from other sources in the Introduction to the IFRA Standards)

CRITICAL EFFECT: SENSITIZATION

Potency Classification

Based on Animal Data2

2910 [4] Weak

NOEL-HRIPT

(induction) (Mg/cm2)

2362

NOEL - HMT (induction) (Mg/cm2)

NA

LOEL1

(induction) (Mg/cm2)

NA

WoE NESIL3

(yg/cm2)

2300 All data in this Table are available from RIFM and are listed in the RIFM Database. NOEL = No observed effect level; HRIPT = Human Repeat Insult Patch Test; HMT = observed effect level; NA = Not Available.

Human Maximization Test; LOEL = lowest

1 Data derived from HRIPT or HMT. 2 Based on animal data using classification defined in ECETOC, Technical Report No. 87, 2003. 3 WoE NESIL limited to two significant figures.

The RIFM Expert Panel reviewed the critical effect data for Vetiveryl acetate and, based on the weight of evidence, established the No Expected Sensitization Induction Level (NESIL) as 2300 mg/cm2. They recommend the limits for the 11 different product categories, which are the acceptable use levels of Vetiveryl acetate in the various product categories. These were derived from the application of the exposure-based quantitative risk assessment approach for fragrance ingredients, which is detailed in the QRA Expert Group Technical Dossier of June 22, 2006.

Jones, L, Foxenberg, R., Laiko, J., Letizia, C., Api, A, 2008, Sensitization potential of vetiveryl acetate evaluated using the Local Lymph Node Assay. The Toxicologist, 102, 298.

RIFM (Research Institute for Fragrance Materials, Inc.), 2008. Local Lymph Node Assay. RIFM report number 55336, July 29. (RIFM, Woodcliff Lake, NJ, USA).

IFRA Standard - Vetiveryl acetate October 14, 2009 2/2