Benzyl Alcohol

The Basics On Benzyl Alcohol

What is Benzyl Alcohol?

An organic alcohol that occurs naturally in some fruits (apricots, cranberries) and teas.

What are other names for Benzyl Alcohol?

external analgesic, fragrance ingredient, oral health care drug, preservative, solvent;viscosity decreasing agent, masking, and solvent

What is Benzyl Alcohol used for?

Benzyl alcohol Lotion, 5%, received full market approval as a prescription medication, for use in patients 6 months of age and older. Benzyl alcohol Lotion, 5%, is the first head lice product approved by the FDA with benzyl alcohol as the active pharmaceutical ingredient1. Benzyl alcohol has been widely used in human medicine as an antimicrobial preservative and as a local anesthetic and antipruritic1. It is used as a local anesthetic to reduce pain associated with Lidocaine injection1. It has been concluded that Benzyl alcohol could be used safely at concentrations of up to 5%, but that manufacturers should consider the nonimmunologic phenomena when using these ingredients in cosmetic formulations designed for infants and children2.

How Benzyl Alcohol is classified

Preservatives

Recommendations for using Benzyl Alcohol during pregnancy and breastfeeding

Is benzoyl alcohol safe during pregnancy? Limited data suggests no known risk

 

Benzyl Alcohol During Pregnancy

What we know about using Benzyl Alcohol while pregnant or breastfeeding

Limited information available.

According to the OECD SIDS initial assessment report on benzyl alcohol, benzoic acid, and its sodium and potassium salts, benzoic acid did not induce reproductive effects in a 4-generation reproductive toxicity study (NOAEL > 750 mg/kg).3 Groups of rats (20 rats/sex/group) received benzoic acid doses of 375 or 750 mg/kg/day in the diet continuously. Animals of the third generation were killed after 16 weeks. Also, test substance–related effects on reproductive organs (based on gross and microscopic examination) were not observed in subchronic studies (rats and mice) on benzyl alcohol and sodium benzoate. In groups of rats fed sodium benzoate (doses up to 5,600 mg/kg/day) during each day of gestation, developmental effects were observed only in the presence of marked maternal toxicity (reduced food intake and decreased body weight; NOAEL = 1,400 mg/kg/day). All developmental effects were observed at doses ≥2,800 mg/kg/day. On days 6 through 10, 15, or 18 of gestation, dosing with sodium benzoate by gavage in hamsters (NOEL = 300 mg/kg body weight), rabbits (NOEL = 250 mg/kg), and CD-1 mice (NOEL = 175 mg/kg) did not result in maternal toxicity; doses >NOEL were not tested. In mice of an unspecified strain dosed with benzyl alcohol by gavage, an NOAEL of 550 mg/kg (only dose) body weight for developmental toxicity was reported. An LOAEL of 750 mg/kg/day (only dose) for developmental toxicity was reported for CD-1 mice dosed orally (gavage) with benzyl alcohol. In this study, maternal toxicity (increased mortality, decreased body weight, and clinical toxicity) was observed.3 Sodium Benzoate The effect of sodium benzoate on biochemical aspects of pregnant female albino rats and survival of their offspring was evaluated using groups of 10 Sprague Dawley rats.65 Two groups of weanling female rats were fed (ad libitum) sodium benzoate at doses of 0.01 g and 0.0125 g in the diet, respectively, daily for 12 weeks. Standard diet was fed to the control group. After mating, the animals were fed ad libitum during pregnancy. When compared to the control group, both doses of sodium benzoate induced a decrease in serum bilirubin and an increase in serum urea. Both doses of sodium benzoate also induced an increase in serum uric acid (P < .01 and P < .05, respectively). Serum alanine aminotransferase activity was significantly greater (P < .01) in the high-dose group but not in the low-dose group. The high dose did not induce a significant increase in serum creatinine. Statistically significant (P < .01) decreases in food intake, hemoglobin, and hematocrit were also reported. Pregnant rats that received high doses of sodium benzoate sustained a 13.6% decrease (P < .05) in mean weight of their pups, when compared to mean pup weight in the corresponding control group.65 Benzyl Benzoate The teratogenicity of benzyl benzoate was evaluated using 21 rats (strains not stated) per dose; doses administered in the diet were defined as 0.04% or 1.0% (≈24 or 595 mg/kg body weight/day).4 The test substance was administered daily from day 0 of gestation to day 21 postparturition. The results of examinations for external, skeletal, or visceral anomalies indicated that benzyl benzoate did not induce harmful effects in fetuses. In a reproductive and developmental toxicity study, pregnant rats (number and strain not stated) were fed diets supplemented with 0.04% or 1.0% benzyl benzoate from day 0 of gestation to day 21 postparturition.66 Another group of rats was fed a control diet. There were no effects on reproductive or developmental toxicity parameters; no external, skeletal, or visceral anomalies were observed in fetuses from either treatment group. Minor variations were observed. A significantly decreased number of fetuses with incomplete sternebrae was noted in the 1% benzyl benzoate treatment group. Testicular atrophy was observed in 2 repeated dose dermal toxicity studies (90 days) on benzyl benzoate involving rabbits.4 The exact doses at which this finding occurred were not stated. However, testicular atrophy was observed at daily doses >0.5 g/kg/day. These studies are summarized in the Repeated Dose Toxicity and Dermal Studies section earlier in the report text. An outbred strain of pregnant Swiss mice (Naval Medical Research Institute mice [NMRI mice]; 34 animals) were injected SC with an unspecified dose of benzyl benzoate in castor oil on days 1 and 11 of gestation.67 The animals were killed on gestation day 17. Untreated mice served as controls. Fetal observations relating to the following were made: counts, sex, weight, and malformations. There was no evidence of test substance–related effects on fetuses. Additional details were not included. A developmental toxicity study was performed using Drosophila melanogaster.68 One group of males and females was raised on food medium with 4% benzyl benzoate in ethanol and the other group was raised on control feed medium. Virgin Canton-S males and females were collected daily for 4 days and then mated. The percentage of eggs hatched was 6.5 times greater in flies on feed containing benzyl benzoate, compared to those on control feed. The safety of benzyl benzoate lotion (25% benzyl benzoate) as a topical treatment for scabies during pregnancy was assessed using a population of 444 pregnant women and their matched controls (1,776 pregnant women).69 The study population consisted of refugee and migrant women attending antenatal clinics on the Thai-Burmese border between August of 1993 and April of 2006. Most first treatments took place during the second and third trimesters, and the overall median gestation exposure was 24.5 weeks. Treated women (444) received 559 applications of butyl benzoate lotion (79.5%, 15.5%, 4.5%, and 0.l5% receiving 1, 2, 3, and 4 treatments, respectively). Conditional Poisson regression was used to estimate risk ratios for outcomes of pregnancy (proportion of abortions, congenital abnormalities, neonatal deaths, stillbirths, and premature babies), mean birth weight, and estimated median gestational age for scabies and scabies-free women. Regarding pregnancy outcomes, there were no statistically significant differences between women treated with the lotion and their matched controls. Thus, there was no evidence of adverse effects on pregnancy outcome due to topical application of benzyl benzoate (25%) lotion.69 Estrogenic Effects Benzoic acid The estrogenic activity of benzoic acid was evaluated in the recombinant yeast human estrogen receptor (ERα) assay in vitro and in uterotrophic assays involving immature female Alpk:APfSD rats (21-22 days old) and immature female Alpk:APfCD-1 mice.70 Immature mouse uterotrophic assays involved 3 daily SC injections of benzoic acid in corn oil (100 and 1,000 µg/kg doses; 5 mL/kg = dose volume) ending on day 4. The same protocol was used for the rat assays, with the exception that benzoic acid in arachis oil was injected (doses of 10, 100, and 1,000 µg/kg). Benzoic acid (10−7 to 10−3 M) was negative in the recombinant yeast human ERα assay in vitro. Overall, benzoic acid produced one statistically significant and 3 statistically nonsignificant increases in average uterine weight (rat assay) and 1 significant and 6 nonsignificant decreases in average uterine weight (mouse assay). Therefore, in all uterotrophic assays, benzoic acid did not produce any reproducible evidence of estrogenic activity. Results for vehicle controls were negative and the positive control, estradiol, was uterotrophic.70 Benzyl benzoate The estrogenic activity of benzyl benzoate (concentration range: 10−9 to 10−4 M) in vitro was evaluated in the E-screen test using MCF7 breast cancer cells. Untreated cultures served as controls. In this test, human breast adenocarcinoma cell line (MCF7 cells) proliferate in the presence of estrogen. Cell numbers were assessed by measurement of the total protein content, using the sulforhodamine B assay. Compared to control cultures, benzyl benzoate did not increase the proliferation of MCF7 cells (P > .05) over the range of concentrations tested.71 The estrogenic activity of benzyl benzoate, benzyl salicylate, and butylphenyl methylpropional (Lilial) in the estrogen-responsive MCF7 human breast cancer cell line was evaluated using the following assays: competitive binding assay to the ER of MCF7 cytosol, competitive binding assay to recombinant ERα and ERβ, and the assay of stably transfected estrogen-responsive reporter gene (ERE-CAT) in MCF7 cells.72 In the latter assay, the ERE-CAT vector consisted of the estrogen response element (ERE) of the vitellogenin A2 gene from −331 to −295 bp cloned into the pBLCAT2 vector upstream of the thymidine kinase promoter. Cell proliferation experiments were also performed. The following results indicate that all 3 chemicals produced estrogenic responses in cultured human breast cancer cells in vitro.72 At 3,000,000-fold molar excess, each chemical was able to partially displace [3H]estradiol from recombinant human estrogen receptors ERα and ERβ and from cytosolic ER of MCF7 cells. At concentrations in the 5 × 10−5 to 5 × 10−4 M range, benzyl benzoate and the other 2 chemicals were able to increase the expression of a stably integrated ERE-CAT and of the endogenous estrogen-responsive pS2 gene in MCF7 cells; however, these effects were at a lesser extent when compared to 10−8 M 17β-estradiol (5,000-50,000 molar excess of benzyl benzoate). In cell proliferation experiments, each chemical increased the proliferation of estrogen-dependent cells over a 7-day period. Cell proliferation was inhibited by fulvestrant (antiestrogen), suggesting an ER-mediated mechanism. However, over a 35-day period, the extent of proliferation in the presence of 10−4 M benzyl benzoate, benzyl salicylate, or butylphenyl methylpropional increased to the same magnitude as that observed in the presence of 10−8 M 17β-estradiol over a 14-day period (10,000 molar excess of benzyl benzoate).72

General safety info about Benzyl Alcohol from CIR

Benzyl alcohol, benzoic acid and its salts, and benzyl benzoate function mostly as fragrance ingredients/preservatives in cosmetic products. The Cosmetic Ingredient Review Expert Panel previously established concentration limits for benzyl alcohol, benzoic acid, and sodium benzoate in cosmetics and determined that the available data were insufficient to support the safety of these ingredients during inhalation exposure. After reviewing newly available data, it was concluded that benzyl alcohol, benzoic acid and its salts, and benzyl benzoate are safe in the present practices of use and concentration described in this safety assessment.

Use this, not that!

Products where you might find Benzyl Alcohol

Indie Lee CoQ-10 Toner; Proactiv Proactiv Solution 3-Step Acne Treatment System, 90 Day Size