Paba

The Basics On Paba

What is Paba?

What are other names for Paba?

4-AMINO- BENZOIC ACID, 4-AMINOBENZOIC ACID, AMINOBENZOIC ACID, ANILINE-4-CARBOXYLIC ACID, BENZOIC ACID, 4-AMINO-, BENZOIC ACID, 4AMINO, P-AMINOBENZOIC ACID, P-CARBOXYANILINE, P-CARBOXYPHENYLAMINE, PABA, and PABA (PARA-AMINOBENZOIC ACID)

What is Paba used for?

PABA is taken by mouth for skin conditions including vitiligo, pemphigus, dermatomyositis, morphea, lymphoblastoma cutis, Peyronie’s disease, and scleroderma. … It is also used to darken gray hair, prevent hair loss, make skin look younger, and prevent sunburn.

How Paba is classified

Sunscreen Actives

Recommendations for using Paba during pregnancy and breastfeeding

Avoid

 

Paba During Pregnancy

What we know about using Paba while pregnant or breastfeeding

Limited information available.

In oral reproductive and developmental toxicity studies on Polyaminopropyl Biguanide (as PHMB HCl) involving rats, NOAECs of 1,000 ppm and 1300 ppm have been reported. In an inhalation study, degeneration of seminiferous tubules in the testis of 1 male rat was observed at a concentration of 0.25 mg/m3 , but this toxic effect was not observed in any other group, including the highest concentration group (26 mg/m3 ). NOAELs of 10 mg/kg/day and 40 mg/kg/day for developmental toxicity were reported in studies involving mice, and the higher dose was also classified as non-teratogenic in mice in another study. A NOAEL of 40 mg/kg/day for developmental toxicity has also been reported in a study involving rabbits. Polyhexamethylene Biguanide (as PHMB) has been classified as embryotoxic at oral dosage rates of 32 mg/kg/day (animal strain not stated) and 100 mg/kg/day (rats), and as teratogenic in rats at an intraperitoneal dosage rate of 10 mg/kg/day

General safety info about Paba from CIR

The safety of Polyaminopropyl Biguanide, used as a preservative in cosmetic products, is reviewed in this safety assessment. Polyaminopropyl Biguanide is the International Nomenclature of Cosmetic Ingredients (INCI) name for an amino polymer comprising propyl biguanide repeat units (polyaminopropyl biguanide (PABA)) or hexyl biguanide repeat units (polyhexamethylene biguanide (PHMB)), or hydrochloride salts thereof. The overwhelming majority of information/data identified in the published literature for inclusion in this safety assessment are on Polyaminopropyl Biguanide (as PHMB HCl), and these data are being used to evaluate the safety of all chemicals identified by the ingredient name Polyaminopropyl Biguanide in cosmetic products. Polyaminopropyl Biguanide, in its neat form, represents a solid/powder of > 94.2 % purity, and is usually marketed as an approximately 20% aqueous solution. One method for manufacturing Polyaminopropyl Biguanide (as PHMB HCl) is via the polycondensation of sodium dicyanamide and hexamethylenediamine. The following chemicals have been reported as possible impurities of Polyaminopropyl Biguanide: N-(6- aminohexyl)-N’-(6-(6-guanidinohexyl)guanidine, N-cyano N’-(6-N-cyanoaminohexyl)guanidine, N-Cyano N’-(6- amnohexyl)guanidine), N-cyano-N’-6-(6-guanidinohexyl)guanidine hydrochloride, and 1,6-diguanidinohexane dihydrochloride. According to 2016 VCRP data, Polyaminopropyl Biguanide is being used in 128 cosmetic products, mostly leave-on products. The results of a concentration of use survey provided in 2016 indicate that Polyaminopropyl Biguanide is being used at concentrations up to 0.5% in both rinse-off and leave-on products. In 2016, the SCCS issued a revised opinion (preliminary opinion) stating that the use of Polyaminopropyl Biguanide as a preservative in all cosmetic products at concentrations up to 0.1% is safe. The opinion also states that, because no new safety data on inhalation are available on Polyaminopropyl Biguanide, its use in sprayable formulations is not advised. The SCCS report recites both Polyaminopropyl Biguanide and Polyaminopropyl Biguanide (as PHMB HCl). The safety of Polyaminopropyl Biguanide (as PHMB HCl) has been reviewed by the United States Environmental Protection Agency (EPA), and the Agency concluded that this pesticide has very low aggregate risk of adverse health effects to the public or environment. The skin penetration of Polyaminopropyl Biguanide (as PHMB HCl) in vitro has been demonstrated using rat and human skin. The principal route of excretion of radioactivity from orally administered Polyhexamethylene Biguanide Hydrochloride (radiolabeled) was in the feces in rat studies. The following components have been detected in the urine of rats fed Polyaminopropyl Biguanide (as PHMB HCl) in the diet: oligomers with 2 cyanoguanidino end groups, as well as the trace constituents, 3,3-dicyano-1,1-hexamethylenediguanidine and a compound that was considered to be 1- (6-aminohexyl)- 3-cyanoguanidine. There was no incidence of mortality or systemic toxicity in rats that received a single dermal dose of 5000 mg/kg aqueous Polyaminopropyl Biguanide (as PHMB HCl); but, hemorrhage of dermal capillaries at the application site was observed. In an acute dermal toxicity study on 20% aqueous Polyaminopropyl Biguanide (as PHMB HCl) involving rabbits, an LD50 > 400 mg/kg was reported. The LD50 was reported to be > 1000 mg/kg for rats dosed orally with aqueous solutions (up to 25% aqueous) of Polyaminopropyl Biguanide (as PHMB HCl). A median lethal dose of 25.6 mg/kg was reported for rats dosed orally with a solution of 0.4% Polyaminopropyl Biguanide (as PHMB). An LC50 of > 0.36 mg/l was reported in acute inhalation toxicity studies in which rats were exposed to Polyaminopropyl Biguanide (as PHMB) solutions (concentrations up to 0.5 mg/l). Dark/red lungs were observed at necropsy. A dose-related depression of respiratory rate was reported in a study in which mice were exposed to Polyaminopropyl Biguanide (as PHMB HCl) at concentrations up to 208 mg/m3 . In a study involving A549 lung cells in vitro, it was noted that Polyaminopropyl Biguanide (as PHMB) induces inflammatory responses via the NF-Œ∫B signaling pathway. In the longest-duration study involving rats, there were no mortalities or signs of systemic toxicity in rats administered a 0.4% solution of Polyaminopropyl Biguanide (as PHMB) over a 60-day period. Similar results were reported for rats after dermal applications of Polyaminopropyl Biguanide (as PHMB HCl) at doses up to 200 mg/kg daily over a 30- day period (21 applications total; no-observed-adverse-effect-level (NOAEL) = 200 mg/kg). In a 21-day dermal toxicity study involving rabbits, there was no evidence of toxic effects on the skin after 20% aqueous Polyaminopropyl Biguanide (as PHMB HCl) was applied. An LOAEL = 0.1 mg/ml for Polyaminopropyl Biguanide (as PHMB HCl) was reported in 28-day oral toxicity studies involving rats. In 21-day and 28-day inhalation toxicity studies on Polyaminopropyl Biguanide (as PHMB HCl) involving rats, NOAEL values of 0.025 mg/m3 and 0.0239 mg/m3 , respectively, were reported. In 90-day toxicity studies on rats and mice, 4000 to 5000 ppm Polyaminopropyl Biguanide (as PHMB HCl) or more in the diet was associated with iron pigment deposits in Kupffer cells in the rats, but no mortalities; the NOAEL was 1000 ppm in both species. In a 60-day and a 90-day study, 0.4% and 20% Polyaminopropyl Biguanide (as PHMB HCl) in drinking water yielded no signs of toxicity in rats and mice, respectively. A NOAELof 5500 ppm was reported for Beagle dogs fed up to11000 ppm Polyaminopropyl Biguanide (as PHMB HCl) in the diet for 90 days. In an 80-week chronic toxicity study (dermal applications 5 days/week), a mortality rate of 75% was reported for the highest dose group (10% Polyaminopropyl Biguanide (as PHMB HCl), 30 mg dose). The exophthalmos observed throughout the study was more severe in this group, but the results of histological examination of the eyes and gross and microscopic examination of the thyroids were negative. In a 104-week oral toxicity study, a NOAEL of 2000 ppm (highest concentration fed in diet) was reported for Polyaminopropyl Biguanide (as PHMB HCl). This concentration corresponded to a daily dose of 36 mg/kg/day in male rats, used to calculate a margin of safety (MOS) of 46, and, more recently, MOS values of 258 and 227. A NOEL (for histopathologic changes) of 200 ppm was reported in a 122-week oral toxicity study involving rats fed Polyaminopropyl Biguanide (as PHMB HCl) at concentrations up to 2000 ppm in the diet. In a study involving mice, feeding with Polyaminopropyl Biguanide (as PHMB HCl) (concentrations up to 1000 ppm in diet) for 97 weeks did not cause any macroscopic changes in tissues examined. A NOAEL of 1500 ppm for Polyaminopropyl Biguanide (as PHMB HCl) was reported in a 1-year feeding study involving dogs, though treatment-related histopathological findings in the liver and kidneys were reported at dietary concentrations of 3000 ppm and 4500 ppm. In a 26-week feeding study involving dogs, dietary concentrations of 1500 ppm and 4500 ppm Polyaminopropyl Biguanide (as PHMB HCl) produced dose-related hepatotoxicity and nephrosis. In oral reproductive and developmental toxicity studies on Polyaminopropyl Biguanide (as PHMB HCl) involving rats, NOAEL values of 1,000 ppm and 1300 ppm have been reported. In an inhalation study, degeneration of seminiferous tubules in the testis of 1 male rat was observed at a dose of 0.25 mg/m3 , but this toxic effect was not observed in any other dose group, including the highest dose group (26 mg/m3 ). NOAEL values of 10 mg/kg/day and 40 mg/kg/day for developmental toxicity were reported in studies involving mice, and the higher dose was also classified as non-teratogenic in mice in another study. A NOAEL of 40 mg/kg/day for developmental toxicity has also been reported in a study involving rabbits. Polyaminopropyl Biguanide (as PHMB) has been classified as embryotoxic at oral doses of 32 mg/kg/day (animal strain not stated) and 100 mg/kg/day (rats), and as teratogenic in rats at an intraperitoneal dose of 10 mg/kg/day. In the Ames test, Polyaminopropyl Biguanide (as PHMB HCl) was non-genotoxic at doses up to 5000 ¬µg/plate with and without metabolic activation. At the highest dose evaluated (333,300 ¬µg/plate) in the Ames test, Polyaminopropyl Biguanide (as PHMB HCl) was weakly genotoxic in strain 1538 without metabolic activation. Polyaminopropyl Biguanide (as PHMB) was non-genotoxic in the mouse lymphoma assay at concentrations up to 2000 ¬µg/ml with and without metabolic activation, and in the in vitro micronucleus test at concentrations up to 50 ¬µg/ml (without metabolic activation) and up to 250 ¬µg/ml (with metabolic activation). In the in vivo micronucleus test, Polyaminopropyl Biguanide (as PHMB HCl) was nonclastogenic in polychromatic erythrocytes from mice that received single oral doses up to 400 mg/kg. In the in vivo unscheduled DNA synthesis assay, there was no induction of unscheduled DNA synthesis in hepatocytes from rats that received single oral doses up to 1500 mg/kg. Polyaminopropyl Biguanide (as PHMB HCl) was evaluated at concentrations up to 3000 ¬µg/ml in the cell transformation assay (using baby hamster kidney fibroblasts), and there was no difference in the number of transformed cell colonies between test and negative control cultures. In another assay involving RAW 264.7 mouse macrophages, Polyaminopropyl Biguanide (as PHMB HCl), tested at concentrations up to 1 ppm, had no direct effect on liver cell proliferation and did not potentiate cell proliferation induced by activated macrophages. Except for a slight increase in some cytokines and transcription factor at concentrations at which cell lysis occurs rapidly, Polyaminopropyl Biguanide (as PHMB HCl) did not exhibit clear and remarkable epigenetic properties. Polyaminopropyl Biguanide (as PHMB HCl) was classified as a hepatic tumorigen in mice, i.e., at the highest dose (30 mg of 10% Polyaminopropyl Biguanide (as PHMB HCl) in ethanol) that was applied to the skin daily (5 days/week) for 80 weeks. An increase in the incidence of liver tumors was observed at the 30 mg/day dose; the increase was statistically significant only for liver tumors of endothelial origin. High mortality (76 to 78% of animals died) was noted in this group. A statistically significant increase in the incidence of hemangiosarcomas and hemangiomas was reported for only male mice that received Polyaminopropyl Biguanide (as PHMB HCl) at a dietary concentration of 4000 ppm daily for 2 years. In a 97-week study in which mice were fed Polyaminopropyl Biguanide (as PHMB HCl) at dietary concentrations up to 1000 ppm prior to and during mating and their offspring were fed the same concentrations, there were no treatment-related (non-neoplastic or neoplastic) increases in histopathologic findings. Hemangiosarcomas or hemangiomas in the liver or other sites were reported in this study along with the high mortality incidence (80%) by week 97. A concentration-related increase (100 to 1000 ppm) in tumor-bearing mice was reported in a similar 97-week dietary study. In a shorter-term feeding study (14 days), increased cell proliferation was noted at a concentration of 1200 ppm Polyaminopropyl Biguanide (as PHMB HCl) in the diet. Polyaminopropyl Biguanide (as PHMB HCl) was classified as non-carcinogenic in rats fed dietary concentrations up to 2000 ppm for 122 weeks. At 124 weeks, 80% mortality overall was reported. A low incidence of hemangiomas and hemangiosarcomas was reported in a study in which rats were fed Polyaminopropyl Biguanide (as PHMB) at a dietary concentration of 2000 ppm for 2 years. A cytotoxicity assay was performed using human keratinocytes (HaCaTs) and murine fibroblasts (L929). When compared directly, Polyaminopropyl Biguanide (as PHMB) consistently resulted in a significantly higher cell survival rate (i.e., less cytotoxicity) than Polyaminopropyl Biguanide (as PHMB), irrespective of concentration and incubation time (P ‚⧠0.0006). The results of animal studies indicate that the skin irritation potential of Polyaminopropyl Biguanide (as PHMB HCl) may be concentration-dependent as well as dependent upon the duration of application. For example, the skin irritation potential of Polyaminopropyl Biguanide (as PHMB HCl) (single 4-h application) was classified as a mild skin irritant in rabbits. Single applications (24 h) of 20% aqueous Polyaminopropyl Biguanide (as PHMB HCl) to rabbits were noncorrosive, moderately irritating to intact skin, and severely irritating to abraded skin. Repeated applications of Polyaminopropyl Biguanide (as PHMB HCl) (12,000 ppm) to the skin of rabbits for 21 days were classified as non-irritating. Polyaminopropyl Biguanide (as PHMB HCl) (up to 1.5% active) was not classified as a primary skin irritant when applied for 24 h to the skin of human subjects. Polyaminopropyl Biguanide (as PHMB) was classified as a non-sensitizer in the local lymph node assay. However, results were mixed in animal studies. In maximization tests, moderate skin sensitization was observed in guinea pigs challenged with Polyaminopropyl Biguanide (as PHMB HCl) (20.2 % active ingredient) and a 30% solution of the ingredient in deionized water, and moderate to strong sensitization was observed in guinea pigs challenged with Polyaminopropyl Biguanide (as PHMB) (20.2% active ingredient). In another guinea pig maximization test, Polyaminopropyl Biguanide (as PHMB HCl) (10% or 20%) was classified as a non-sensitizer. Very strong irritation potential, but no significant photoirritancy, was reported in a study in which male rats were tested with Polyaminopropyl Biguanide (as PHMB HCl) at concentrations of 2% and 5%. When tested at a concentration of 1%, in 26 subjects, Polyaminopropyl Biguanide (as PHMB HCl) was essentially non-irritating and did not induce sensitization, phtotoxicity, or photoallergenicity. Case reports with sensitization reactions to Polyaminopropyl Biguanide (as PHMB), an ingredient of wet wipes, and wet wipes containing this ingredient have been reported. Undiluted and 25% aqueous Polyaminopropyl Biguanide (as PHMB HCl) were severe ocular irritants when instilled into unrinsed rabbit eyes. Polyaminopropyl Biguanide (as PHMB HCl) (20% aqueous) induced slight inflammation, and Polyaminopropyl Biguanide (as PHMB HCl) (0.04% active ingredient) was non-irritating to the eyes of rabbits. In a study in which 20% aqueous Polyaminopropyl Biguanide (as PHMB HCl) was instilled into human eyes and the eyes of rabbits in a temperature-controlled chamber, normal corneal morphology was observed at histological examination.

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Products where you might find Paba

Replenix Gly-Sal 2-2 Pads (60 count); Glycolix Elite Treatment Pads 20% (60 count); Peter Thomas Roth Max Complexion Correction Pads; HUM Nutrition Hair Sweet Hair Growth – Vegan Gummies; REN Clean Skincare Evercalm Overnight Recovery Balm; REN Clean Skincare AHA Smart Renewal Body Serum