CYCLOTETRASILOXANE

EU 1223/2009 Annex II — SCCS opinion: Opinion on Octamethylcyclotetrasiloxane (D4)

EU 1223/2009 Annex II — SCCS opinion: Opinion on Cyclomethicone: D4 and D5

Acute Toxicity Oral – Non-human BIS-PEG-15 METHYL ETHYL DIMETHICONE The oral LD 50 of bis-PEG-15 methyl ethyl dimethicone was > 4640 mg/kg for rats. No further information was provided.9,23  Distributed for Comment Only -- Do Not Cite or Quote CETYL PEG/PPG-10/1 DIMETHICONE The oral LD 50 of cetyl PEG/PPG-10/1 dimethicone was > 5000 mg/kg for Wistar rats (n=5).12 The rats were observed for 14 days. There were no mortalities; one rat exhibited ano-genital staining on day 1. LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE The oral LD 50 of lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be 5000 mg/kg for rats.24 There were no adverse effects observed. PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE The oral LD 50 of PEG-9 polydimethylsiloxyethyl dimethicone in rats was reported to be >5000 mg/kg.7 No mortalities or clinical signs were observed. PEG/PPG-19/19 DIMETHICONE The oral LD 50 of PEG/PPG-19/19 dimethicone (100%) was > 16 mL/kg in CFE rats (n=5/sex).25 Controls were administered with tragacanth mucilage (0.5%). Clinical signs included piloerection and diuresis. All rats appeared healthy four days after dosing and gained weight normally. Necropsies were unremarkable. PEG/PPG-25/25 DIMETHICONE There were no mortalities or clinical signs in Sprague-Dawley rats (n=5/sex) orally administered a single dose of PEG/PPG-25/25 dimethicone (2007 mg/kg).26 There were no behavioral abnormalities or physiological findings. Body weights were similar to controls. The test substance was administered neat. The rats were observed for 14 days and then necropsied. The authors concluded that the oral LD 50 is ≥ 2007 mg/kg. Dermal – Non-human BIS-PEG/PPG-14/14 DIMETHICONE The dermal LD 50 of bis-PEG/PPG-14/14 dimethicone, under occlusion, in Wistar rats (n=10) was >2000 mg/kg. … [kırpıldı — bölüm toplam 38106 karakter]

Definition and Structure All of the ingredients in this report are alkoxylated derivatives of polysiloxanes, specifically dimethicones. Within this grouping, there are three primary configurations: 1) end-capped dimethicone, wherein a dimethicone polymer is terminated on either end with an alkoxy group (e.g., cetyloxy); 2) alkoxy-dimethicone/dimethicone co-polymers; and 3) some combination of 1 and 2 (Figure 1).  Distributed for Comment Only -- Do Not Cite or Quote In general: CH3 CH3 CH3 CH3 CH3 CH3 CH3 R Si O Si O Si R H 3C Si O Si O Si O Si CH3 or/and CH3 CH3 CH3 CH3 CH3 R CH3 n x y -wherein R is an alkoxy or polyalkoxy group For example, Bis-Stearoxyethyl Dimethicone is the ingredient wherein R is stearoxyethyl: CH3 CH3 CH3 H 3C O O Si O Si O Si CH3 CH3 CH3 x … [kırpıldı — bölüm toplam 10191 karakter]

EPA ToxValDB skin/eye data — endpoint: Skin Sensitization, classification: Classification not possible. 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: Studies Indicate No Significant Irritation, species: rabbit, study: eye irritation, guideline: OECD Guideline 405 (Acute Eye Irritation / Corrosion) equivalent or similar to, year: 1979. 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) equivalent or similar to, year: 1971. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data — endpoint: skin sensitisation: in vivo (non-LLNA), classification: Not likely to be sensitizing, species: guinea pig, study: skin sensitization, guideline: according to OECD Guideline 406 (Skin Sensitisation), year: 1985. 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 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.