PANTHENOL

The following is general dermal penetration data: Panthenyl Triacetate Panthenyl Triacetate has been reported to convert to Panthenol and Pantothenic Acid upon dermal application to human skin.43,44 Panthenyl Triacetate has also been reported to penetrate underarm skin.44 Provided below are summaries of dermal and nail penetration experiments that are presented in detail in Table 5. Dermal Penetration In Vitro Animal The cutaneous penetration of D-Panthenol (10% in a hydrophilic gel formulation) through the skin of pigs was examined, with and without sonophoresis, in a diffusion cell experiment.45 The gel formulation was applied to an 8 cm2 skin area in the diffusion cell; the receptor cell fluid (water), in contact with the dermis, was collected periodically between 2 and 240 minutes after application of the formulation. The penetration of D-Panthenol into pig skin was enhanced by the use of the ultrasound technique. A steady increase in D-Panthenol concentration was observed in receptor cell fluid from 2 to 120 minutes, with a plateau reached by 180 minutes (903 µg/ml without ultrasound and 1069 µg/ml with ultrasound). Human The dermal penetration of 14C-Panthenol (20 mg/ml in ethanol, 0.05 mCi/ml) through human abdominal skin samples was evaluated in a Franz (static) diffusion cell experiment.46 Skin samples were either not stripped or stripped 5x or 10x prior to the application of 10 µl test substance. The receptor solution (0.01 mol/l phosphate buffered saline with 5%, v/v, polyethylene glycol) was collected up to 60 minutes post-application, and then skin samples were stripped 20x. In the skin samples not stripped prior to test substance application, the amount of applied radioactivity detected was 84% in the stratum corneum, 6% in the epidermis, and 4% in the dermis. For the 5x stripped samples, the radioactivity detected in the stratum corneum, epidermis, and dermis was 81%, 8.7%, and 6%, … [kırpıldı - bölüm toplam 12978 karakter]

Definition and Structure The derivative ingredients in this report are related to Panthenol and Pantothenic Acid, sharing the same structural core. Each ingredient is an ethyl ether, acetyl ester, or simple salt of either Panthenol or Pantothenic Acid (Figure 1). Calcium Pantothenate is more chemically stable than the unstable forms of free Pantothenic Acid and Sodium Pantothenate.17 The dextrorotatory (D-) forms and dextrorotatory, levorotatory (D,L-) forms of the ingredients are referred to in this safety assessment when that information was provided. Vitamin activity of Pantothenic Acid is limited to the D- form.18 Figure 1. Panthenol and Pantothenic Acid, the core structures of the ingredients in this report.  Distributed for comment only -- do not cite or quote Physical and Chemical Properties Panthenol is a white, crystalline powder (racemic mixture of D- and L- forms) with a molecular weight of 205 g/mol and a melting point of 63 °C.6,19 Pantothenic Acid is a hygroscopic oil with a molecular weight of 219 g/mol and a boiling point of 551 °C.18,20 Calcium Pantothenate and Sodium Pantothenate, salts of Pantothenic Acid, are highly hygroscopic, water soluble, crystalline solids with melting points between 170 and 200 °C, and formula weights of 476 g/mol and 241 g/mol, respectively (Table 2).18,21-23 The remaining ingredients in this report are liquids with boiling points greater than 400 degrees Celsius, and molecular weights ranging from 233 to 331 g/mol.24-26 Calcium Pantothenate When used as a nutritional additive in animal feed, D-Calcium Pantothenate was reported to have a “dusting potential” (mass of the particles per m3 drawn from a rotating drum containing the test material)27 of 1.1 g/m3 and the particle size fraction < 50 µm was … [kırpıldı - bölüm toplam 13845 karakter]

In rabbit skin treated with 100% D- and DL-Panthenol and covered with an occlusive patch for 4 hours, slight erythema was observed, however it cleared within 24-48 hours following patch removal.4 There were no signs of irritation to abraded and intact rabbit skin treated with 2% D- and DL-Panthenol. Rabbits were treated in different experiments with 0.5% Panthenol for 4 to 14 days yielding the following results: erythema 24 hours after patch removal; erythema and edema 48 hours post-application that lasted for 7 days; moderate to severe erythema and mild edema persisting for 7 days; and no dermal irritation after 14 days of treatment. Panthenol (0.5%) was non-comedogenic in rabbit skin. A product containing 0.5% Panthenol was applied to the skin of human subjects for 4 days, in a cumulative irritation test (procedures were not provided); results indicated that the test substance was non-irritating.4 In a different study, a lotion containing 0.5% Panthenol was applied (occlusively) to the backs of 10 subjects. After 23 hours the patch was removed and skin washed prior to evaluation. This process was repeated for 21 days. Eight subjects exhibited minimal erythema during the test; study researchers determined that the test substance was mildly irritating. Panthenol, in various products, was applied to the skin of human subjects and occlusively covered for 24-48 hours during the induction and challenge phases of different experiments.4 In one test, erythema and papules were observed in 3 out of 200 subjects during induction and challenge phases (0.5% Panthenol). Erythema and edema were seen in 3 out of 206 subjects during the induction and challenge phases (0.5% Panthenol) of another test. Erythema was reported in 1 out of 238 subjects during the induction phase (0.5% Panthenol) of an experiment. There were no signs of irritation or sensitization in another study with 200 … [kırpıldı - bölüm toplam 8119 karakter]

Panthenol Human subjects in a dermatitis clinic were patch tested using a standard diagnostic series that included a 50% DL-Panthenol solution.69 Positive reactions to DL-Panthenol were reported in 2 of 192 (1%) subjects. In a 10-week, randomized, double-blind trial, 207 women with epidermal hyperpigmented facial spots were treated 2x/day with a lotion containing 0.5% Panthenol, 4% niacinamide, 0.5% tocopheryl acetate, sunscreen, glycerol, and other unspecified ingredients or a control lotion (no further details provided).70 There were 6 subjects in the treatment group and 2 in the control group reporting a mild, transient burning sensation; 1 subject in the treatment group reported dry skin and increased acne. TEWL decreased in treatment and control groups; hyperpigmentation spots were statistically significantly reduced in treatment groups as compared to controls. Retrospective and Multicenter Studies D-Panthenol A European Union report cited data from the Information Network of Departments of Dermatology from 2000 to 2009, documenting 137 positive allergic reactions from a large population of > 96,000 patients to D-Panthenol (no further details provided).71 D-Panthenol was classified by the study researchers to be a “rare” allergen. A total of 3301 patients were patch tested for D-Panthenol (5% pet.) from 1990 to 2016.72 The patch tests were designed based on a pharmaceutical or cosmetic series or according to the use of D-Panthenol in products the patients were using. The European Society of Contact Dermatitis guideline was followed when readings were performed on days 2, 4, and after. Some patients were sensitized  Distributed for comment only -- do not cite or quote based on prescription or cosmetic products they used containing D-Panthenol. There were 23 of 3301 patients (0.7%) who had … [kırpıldı - bölüm toplam 5509 karakter]

In rabbit skin treated with 100% D- and DL-Panthenol and covered with an occlusive patch for 4 hours, slight erythema was observed, however it cleared within 24-48 hours following patch removal.4 There were no signs of irritation to abraded and intact rabbit skin treated with 2% D- and DL-Panthenol. Rabbits were treated in different experiments with 0.5% Panthenol for 4 to 14 days yielding the following results: erythema 24 hours after patch removal; erythema and edema 48 hours post-application that lasted for 7 days; moderate to severe erythema and mild edema persisting for 7 days; and no dermal irritation after 14 days of treatment. Panthenol (0.5%) was non-comedogenic in rabbit skin. A product containing 0.5% Panthenol was applied to the skin of human subjects for 4 days, in a cumulative irritation test (procedures were not provided); results indicated that the test substance was non-irritating.4 In a different study, a lotion containing 0.5% Panthenol was applied (occlusively) to the backs of 10 subjects. After 23 hours the patch was removed and skin washed prior to evaluation. This process was repeated for 21 days. Eight subjects exhibited minimal erythema during the test; study researchers determined that the test substance was mildly irritating. Panthenol, in various products, was applied to the skin of human subjects and occlusively covered for 24-48 hours during the induction and challenge phases of different experiments.4 In one test, erythema and papules were observed in 3 out of 200 subjects during induction and challenge phases (0.5% Panthenol). Erythema and edema were seen in 3 out of 206 subjects during the induction and challenge phases (0.5% Panthenol) of another test. Erythema was reported in 1 out of 238 subjects during the induction phase (0.5% Panthenol) of an experiment. There were no signs of irritation or sensitization in another study with 200 … [kırpıldı - bölüm toplam 10895 karakter]

Cited by 44. In a randomized, double-blind, placebo-controlled study the effect of topical dexpanthenol (CAS 81-13-0) formulated in two different lipophilic vehicles on epidermal barrier function in vivo was carried out. Seven days' treatment with dexpanthenol improved stratum corneum hydration and reduced transepidermal water loss. Active treatment was statistically different from the vehicle control on both

Cited by 21. Background Panthenol (synonym: dexpanthenol), the alcohol analogue of panthothenic acid, is frequently included in moisturizers, wound-healing agents, and other cosmetics, and has been shown to be responsible for allergic contact dermatitis (ACD). Objectives To evaluate the frequency of ACD caused by dexpanthenol, and to characterize reactive patients. Methods We retrospectively reviewed the files

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: 1978. 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: Category 6.3B (Category 3). Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.

EPA ToxValDB skin/eye data - endpoint: Eye Irritation, classification: Category 6.4A (Category 2A). 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) according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) according to, year: 1990. Caveat: this is an aggregated record; dose, species and route of exposure must be considered together.