Benzoic Acid

The Basics On Benzoic Acid

What is Benzoic Acid?

A type of BHA used as a preservative used in skincare products.

What are other names for Benzoic Acid?

BENZENECARBOXYLIC ACID, BENZENEFORMIC ACID, BENZENEMETHANOIC ACID, BENZOIC ACID, BENZOIC ACID,, CARBOXYBENZENE, DRACYCLIC ACID, PHENYLCARBOXYLIC ACID, and PHENYLFORMIC ACID

What is Benzoic Acid used for?

As a preservative in cosmetic formulations, it is primarily an anti-fungal agent that prevents fungi from developing in products and formulas and changing their composition. It is less effective against bacteria. Benzoic acid has a long history of use as an antifungal agent in topical therapeutic preparations such as Whitfield’s ointment (benzoic acid 6% and salicylic acid 3%) 2. It has been used with salicylic acid as a topical antifungal agent and in the treatment of athletes foot and ringworm2. When Sodium benzoate is used as a preservative, the pH of the final formulation may have to be lowered to facilitate the release of the free benzoic acid for useful activity. Potassium sorbate is often combined with Sodium benzoate in low pH products to provide a synergistic preservative effect against yeast and mold. It has been concluded that benzoic acid can be used safely at concentrations up to 5%, but that consideration should be given the nonimmunologic phenomena when using this ingredient in cosmetic formulations designed for infants and children.

How Benzoic Acid is classified

Preservatives

Recommendations for using Benzoic Acid during pregnancy and breastfeeding

Limited data suggests no known risk

 

Benzoic Acid During Pregnancy

What we know about using Benzoic Acid while pregnant or breastfeeding

Limited information available.

In an OECD SIDS assessment report, benzoic acid (up to 750 mg/kg/day) was not a reproductive toxicant in rats in a fourgeneration reproductive toxicity study, and repeated doses of sodium benzoate (0.01g in diet) did not induce reproductive Distributed for Comment Only РDo Not Quote or Cite CIR Panel Book Page 19 13 effect in rats. Developmental effects were observed in the presence of marked maternal toxicity in rats fed sodium benzoate in the diet ( ≥ 2800 mg/kg/day; NOAEL = 1400 mg/kg/day) in another study; maternal toxicity was not observed in hamsters (doses up to 300 mg/kg/day, also the NOEL), rabbits (doses up to250 mg/kg/day, also the NOEL) ,or CD-1 mice (doses up to 175 mg/kg/day, also the NOEL). Benzyl alcoholwas not a developmental toxicant in CD-1 mice (doses up to 750 mg/kg/day, also the LOAEL) or in mice of an unspecified strain (doses up to550 mg/kg/day, also the NOAEL) dosed by gavage. Benzyl benzoate(up to 1% in the diet) was not found to be teratogenic in rats dosed orally. However, testicular atrophy was observed in rabbits that received repeated dermal doses of benzyl benzoate (up to 1% in diet). There was no evidence of adverse effects on pregnancy outcome in a study on the safety of topical application of benzyl benzoate (25%) lotion in pregnant women. Benzoic acid (up to 1,000 µg/kg, s.c. injection) did not induce any reproducible evidence of estrogenic activity in uterotrophic assays involving immature female Alpk:APfSD rats and female Alpk:APfCD-1 mice. Benzyl benzoate induced weak estrogenic responses in certain tests using cultured human breast cancer cells in vitro, but not in others. Benzoic Acid, Sodium Benzoate, Potassium Benzoate, and Benzyl Alcohol 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 four-generation reproductive toxicity study (NOAEL > 750 mg/kg).2 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 5600 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 = 1400 mg/kg/day). All developmental effects were observed at doses ≥ 2800 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, reduced body weight, and clinical toxicology) was observed.2 Sodium Benzoate and Benzyl 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.66 Two groups of weanling female rats were fed (ad libitum) an acceptable dose (0.01 g) and high dose (0.0125 g) of sodium benzoate in the diet 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. The high and unacceptable doses of sodium benzoate also induced an increase in serum uric acid (p < 0.01 and p < 0.05, respectively). Serum alanine aminotransferase (ALT) activity was significantly greater (p < 0.01) in the high dose group, but not at the acceptable dose. The high dose did not induce a significant increase in serum creatinine. Statistically significant ( p < 0.01) decreases in food intake, hemoglobin, and hematocrit were also reported. Pregnant rats that received high doses of sodium benzoate sustained a significant decrease (p < 0.05) in mean weight of their pups, and this decrease amounted to 13.6% of the corresponding mean control group weight.66 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).3 The test substance was administered daily from day 0 of gestation to day 21 post-parturition. 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 (no. and strain not stated) were fed diets supplemented with 0.04 or 1.0% benzyl benzoate from day 0 of gestation to day 21 post-parturition.52 Another group of rats was fed a control Distributed for Comment Only РDo Not Quote or Cite CIR Panel Book Page 20 14 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.3 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 – Parenteral Studies section earlier in the report text. Pregnant NMRI mice (34 animals) were injected s.c. with an unspecified dose of benzyl benzoate in castor oil on days 1 and 11 of gestation.52 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. 52 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).67 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.67 Benzoic Acid, Benzyl benzoate; Estrogenic effects The estrogenic activity of benzoic acid was evaluated in the recombinant yeast human estrogen (ERα) receptor assay in vitro and in uterotrophic assays involving immature female Alpk:APfSD rats (21 to 22 days old) and immature female Alpk:APfCD-1 mice.68 Immature mouse uterotrophic assays involved 3 daily s.c. 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) produced negative results in the recombinant yeast human estrogen (ERα) receptor assay in vitro. Overall (rat and mouse assays), benzoic acid produced one statistically significant and 3 statistically nonsignificant increases in average uterine weight and one significant and 6 nonsignificant decreases in average uterine weight. 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.68 The estrogenic activity of benzyl benzoate (concentration range: 10-9 to 10-4 M) in vitro was evaluated in the E-screen test using MCF-7 breast cancer cells. Untreated cultures served as controls. In this test, MCF-7 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 MCF-7 cells (p > 0.05) over the range of concentrations tested.69 The estrogenic activity of benzyl benzoate, benzyl salicylate, and butylphenylmethylpropional (Lilial) in the estrogenresponsive MCF7 human breast cancer cell line was evaluated using the following assays: competitive binding assay to Distributed for Comment Only РDo Not Quote or Cite CIR Panel Book Page 21 15 estrogen receptor (ER) of MCF7 cytosol, competitive binding assay to recombinant ERα and ERβ, and the assay of stably transfected ERE-CAT reporter gene in MCF7 cells.70 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 (tk) 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. 70 At 3,000,000-fold molar excess, each chemical was able to partially displace [3 H]estradiol from recombinant human estrogen receptors ERα and ERβ, and from cytosolic ER of MCF7 cells. At concentrations in the 5 x 10-5 to 5 x 10-4 M range, benzyl benzoate and the other 2 chemicals were able to increase the expression of a stably integrated estrogen-responsive reporter gene (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 to 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 butylphenylmethylpropional 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).70

General safety info about Benzoic Acid from CIR

No report found.

Use this, not that!

Products where you might find Benzoic Acid

Replenix Acne Gel Benzoyl Peroxide; La Roche-Posay Effaclar Duo Acne Treatment with Benzoyl Peroxide; Jan Marini Benzoyl Peroxide Wash; Maison Louis Marie No.03 L’Etang Noir Perfume Oil