PHENOXYETHANOL

EU 1223/2009 Annex V - SCCS opinion: Opinion concerning Restrictions on Materials listed in annex VI of Directive 76/768/EEC on Cosmetic Products

EU 1223/2009 Annex V - SCCS opinion: OPINION ON Phenoxyethanol

Details on the dermal sensitization studies summarized below can be found in Table 4. An eyelash product containing 0.018% Ethyl Tafluprostamide (n = 51; tested neat) and 7.5% Ethyl Tafluprostamide in phenoxyethanol (n = 54) were considered to be non-sensitizing in human repeat insult patch tests (HRIPTs).4 HRIPTs were also performed using eyelash serums containing Isopropyl Cloprostenate (0.0044% and 0.005%; tested neat; n = 50-56).14-17 The majority of assays were performed under semi-occlusive conditions. The serums tested were considered to be non- irritating and non-sensitizing in all assays.

EPA ToxValDB skin/eye data - endpoint: Eye Irritation, classification: Category 2. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Skin Irritation, classification: Not classified. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Skin Sensitization, classification: Not classified. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: eye irritation: in vivo, classification: Severe Irritation, species: rabbit, study: eye irritation, guideline: OECD Guideline 405 (Acute Eye Irritation / Corrosion) according to, year: 1983. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: skin irritation: in vivo, classification: Studies Indicate No Significant Irritation, species: rabbit, study: skin irritation, guideline: OECD Guideline 404 (Acute Dermal Irritation / Corrosion) according to, year: 1983. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxCast ER model: NO estrogen receptor activity found (AUC agonist=0, antagonist=0). Tested in 18 in vitro assays. Caveat: this is an in vitro screening model with no dose or exposure context; it does NOT mean an effect occurs in humans at cosmetic use levels.