Cetyl Esters

The Basics On Cetyl Esters

What is Cetyl Esters?

Synthetic wax used in cosmetics as a thickening agent and emollient.

What are other names for Cetyl Esters?

CETYL ESTERS, SPERMACETI WAX; SPERMACETI WAX, REFINED, and SYNTHETIC SPERMACETI WAX

What is Cetyl Esters used for?

Cetyl Esters is a wax mixture consisting primarily of esters of saturated fatty alcohols and saturated fatty acids. It can be used in emulsions and anhydrous products to impart a lubricious feel and soft gloss to these formulations. It is used as a stiffening agent and emollient in creams, lotions and ointments.

How Cetyl Esters is classified

Texture Enhancer, Emollients

Recommendations for using Cetyl Esters during pregnancy and breastfeeding

Limited data suggests no known risk

 

Cetyl Esters During Pregnancy

What we know about using Cetyl Esters while pregnant or breastfeeding

Limited information available.

Daily doses of pelargonic acid up to 1,500 mg/kg/day did not induce reproductive effects in inseminated female rats. Results from other studies support pelargonic acid daily doses of 1500 mg/kg/day as the no-observableeffect-level (NOEL) for maternal/developmental toxicity in rats, and isononyl isononanoate daily doses of 300 mg/kg/day as the NOEL for developmental toxicity in rats. In a teratogenicity study on cetearyl isononanoate, the NOAEL for maternal toxicity and embryo-/fetotoxicity in rats was 1000 mg/kg body weight. Two branched-chain nonanols (perhaps incorrectly identified as isononanol) caused a marked degree of maternal and fetal toxicity in rats at daily doses of 7.5 and 10 mmol/kg/day (1,185 and 1,580 mg/kg/day) and slight fetal effects at 5 mmol/kg/day doses. Neopentyl glycol at oral doses up to 1,000 mg/kg/day did not induce reproductive effects. Pelargonic Acid A study by Hazleton Labs America Inc.36 conducted to determine the appropriate dose level of pelargonic acid for a teratology screening study involving Cesarean-derived, Sprague-Dawley rats. Details relating to the conduct of this study are included in the section on Short-Term Oral Toxicity earlier in the report text. The number of corpora lutea per ovary and the number and placement of uterine implantations, resorptions, and live and dead fetuses were recorded. Mean ovarian and uterine weight data were comparable between treated and control groups. No treatmentrelated reproductive effects were noted over the range of administered doses (1.0 to 10.0 ml/kg). A study designed to evaluate the embryo/fetal toxicity and teratogenic potential of pelargonic acid was conducted using groups of 22 mated female Crl:COBS, CD®(SD)BR rats (14 weeks old).73 Females of the test group were dosed orally (by gavage) with pelargonic acid (in corn oil; dose = 1500 mg/kg) on gestation days 6 through 15. The control group received corn oil according to the same procedure. Pregnant females were killed on day 20 and fetuses were delivered by cesarean section. Neither test substance-related maternal toxicity nor effects on food and water consumption were observed in the test or control group. Additionally, there was no definitive evidence of teratogenic effects in the test or control group. EPA33 reported the results of a developmental toxicity study involving rats. Treatment of the animals with pelargonic acid had no adverse effects on clinical signs, body weight gain, or food/water consumption. Fetal toxicity was not observed in treated rats or in untreated control rats, and the following parameters were comparable between treated and control rats: mean number of viable fetuses, early or late resorptions, implantation sites, corpora lutea, preand post-implantation losses, sex ratios, and fetal body weights. The no-observed-effect level (NOEL) for maternal and developmental toxicity was 1500 mg/kg/day, and the LOEL was greater than 1500 mg/kg/day. Cetearyl Isononanoate A summary of a 1993 teratogenicity study on Cetiol ® SN (cetearyl isononanoate, % not stated) was provided by the Personal Care Products Council.64 Three groups of pregnant CD rats received oral doses (gavage; dose volume = 10 ml/kg) of 100, 300, and 1000 mg/kg body weight, respectively, from day 6 to day 15 of gestation. A fourth group served as the untreated control. None of the animals died and maternal body weight gain was not affected by treatment. All of the females had viable fetuses, and pre-implantation loss and mean numbers of resorptions were not affected by treatment. Non-dose-related post-implantation loss was observed in treatment groups. All parameters were said to have been comparable to those of the control group. The results of skeletal and visceral examinations did not provide evidence of any treatment-related malformations. The NOAEL for maternal toxicity and embryo-/fetotoxicity was 1000 mg/kg body weight. Isononyl Isononanoate The developmental toxicity of isononyl isononanoate (in corn oil) was evaluated using groups of 10 mated female Sprague-Dawley rats.74 The 3 test groups received doses of 30, 100, and 300 mg/kg/day, respectively, by gavage on day 6 to day 17 post-coitum. The control group was dosed with corn oil. There was no evidence of treatment-related, macroscopic post-mortem findings in any of the females, and none of the animals died. There was also no evidence of total resorption or abortion. The number of implantation sites and corpora lutea per female was similar in all dose groups, and, compared to controls, the number of resorptions (early and late) and post-implantation loss per female in either dose group were similar. Additionally, there were no differences in the number of live fetuses in either dose group when compared to controls, and neither external anomalies nor malformations were observed. It was concluded that isononyl isononanoate did not induce direct embryotoxicity or fetotoxicity at doses up to 300 mg/kg/day. Isononyl Alcohol Hellwig and Jäckh75 studied the developmental toxicity of isononyl alcohol using sexually mature, virgin Wistar rats of outbred strain Chbb/THOM. The 2 types of isononyl alcohol, both identified as CAS No. 68515-81-1, tested were defined as follows: Isononanol type 1 (purity ≥ 99%) – of commercial origin and consisted of roughly equivalent amounts of 3,4-, 4,6-, 3,6-, 3,5-, 4,5-, 5,6-dimethylheptanol-1. Isononanol type 2 (purity ≥ 99%) – produced at BASF and the following were listed as main components: 4,5-diemthylheptanol-1 (~23%), 4-methyloctanol-1 (29%), 3-ethylheptanol-1 (3%), 6-methyloctanol-1 (15%), and 3-ethyl-4-methylhexanol (1%) [Note: Based on these chemical composition data, there is reason to believe that neither chemical (type 1 or 2) is isononanol. However, it is evident that both are branched-chain nonanols]. The test substances were diluted (twice-distilled water, employing ~ 0.005% Cremophor EL [PEG-35 Castor Oil] as emulsifier) to a standard dose volume of 5 ml/kg body weight. Each test substance was administered by gavage (doses ranging from 1 to 10 mmol/kg/day) to pregnant females (10/group) on days 6 to 15 post-coitum. Two control groups were treated with either doubly-distilled water alone (control group 1) or water plus ~ 0.005% Cremophor EL (control group 2). Both isononanols (types 1 and 2) exhibited a marked degree of maternal and fetal toxicity at daily doses of 7.5 and 10 mmol/kg/day, and slight fetal effects at 5 mmol/kg/day doses. Of the fetal findings (malformations, variations, or retardations), the only ones that were significantly different from controls were the number of fetuses with skeletal retardations in the 5 mmol/kg/day dose group (p < 0.1, both control groups) and the number with skeletal variations in this group (p < 0.05; 1 control group). Dosing at 1 mmol/kg/day did not cause adverse effects. When pregnant females were dosed with 7.5 mmol/kg /day (isononanol type 1) in a supplementary experiment, the incidence of malformations (mainly related to the heart) was statistically significantly increased (p < 0.01; 1 control group). Resorptions and postAlkyl Esters Supplement Book 1 Supplement Panel Book 1 Page 232 21 implantation loss were also significantly increased (p < 0.01; 1 control group) at this dose level. For isononanol type 2, the only significant fetal findings (7.5 mmol/kg/day doses) were the number of fetuses with skeletal retardations (p < 0.01, 0.05; 1 control group – both values), number of fetuses with skeletal variations (p < 0.051 1 control group), number of fetuses with variations (p < 0.05; 1 control group) and number of fetuses with malformations (p < 0.05; 1 control group). Resorptions were also significantly increased (p < 0.05; both control groups). Neopentyl Glycol A combined repeated dose and reproductive/developmental toxicity study on neopentyl glycol was performed using groups of male and female rats of the Slc: SD strain.28 The test substance, in distilled water, was administered by gavage at doses of 100, 300, or 1,000 mg/kg/day. Control rats were dosed with distilled water. Male rats were dosed over a 42-day period and female rats were dosed from 14 days before mating to day 3 of lactation. There were no test substance-related effects on copulation, fertility, or the estrous cycle of rats, and the same was true during the lactation period. With the exception of one control rat, delivery was normal for all dams. There were no test substance-related abnormal findings in any of the pups delivered. The body weight gain of pups was normal up to day 4 of lactation. Test substance-related, abnormal gross findings were not reported for stillborn, dead pups or pups killed at day 4 of lactation. Additionally, no developmental toxic effects were associated with test substance administration. The NOAEL for neopentyl glycol (P and F1 generations) was 1,000 mg/kg. Results relating to the short-term oral toxicity of neopentyl glycol are included earlier in the report text.

General safety info about Cetyl Esters from CIR

The CIR Expert Panel assessed the safety of 237 alkyl esters for use in cosmetics, concluding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be non-irritating. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and, where there were data gaps, similarity in structure, properties, functions and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group

Use this, not that!

Products where you might find Cetyl Esters

Estee Lauder Revitalizing Supreme+ Global Anti-Aging Cell Power Creme; Perricone MD Vitamin C Ester Photo-Brightening Moisturizer SPF 30, Perricone MD Vitamin C Ester CCC+ Ferulic Brightening Complex 20%, Perricone MD Vitamin C Ester Brightening Overnight Treatment