JPH11228380A - Cosmetic for improving chapped skin - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain the subject cosmetic having excellent activities for preventing chopped skin and improving the chopped skin by including pyridoxine (derivative) and a specific natural moisturizing factor. SOLUTION: The objective cosmetic contains (A) 0.001-5.0 wt.%, preferably 0.01-2.0 wt.% pyridoxine (derivative), (B) 0.001-10 wt.%, preferably 0.01-5 wt.% natural moisturizing agent present in a skin cuticular layer, and (C) optionally an oil component, a surfactant, a humectant, a higher alcohol, a sequestering agent, a natural and synthetic polymer, an ultraviolet absorber, a blood circulation accelerator, various kinds of extracts, inorganic and organic pigments, inorganic and organic clayey minerals, a coloring agent such as an organic dye, a preservative, or the like. Pyridoxine hydrochloride and the like are preferable as the component A. Pyrrolidonecarboxylic acid salt, an amino acid, minerals (calcium, magnesium, sodium and potassium) and the like are preferably used as the component B.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a cosmetic for improving skin roughness, and more particularly to a cosmetic for improving skin roughness and preventing skin roughness.

[0002]

BACKGROUND OF THE INVENTION Hitherto, pyridoxine (ie, vitamin B6) or a derivative thereof has been used for suppressing sebum and improving skin roughness.
When used alone, the effect was not always sufficient. Further, the NMF component has conventionally been used as a humectant, but the effect of improving skin roughness has not always been sufficient.

The present invention has been made to solve the above-mentioned problems of the prior art, and an object of the present invention is to provide a cosmetic having a more excellent effect of preventing and improving skin roughness.

[0004]

Means for Solving the Problems As a result of intensive studies to achieve the above object, the present inventors have found that when pyridoxine or a derivative thereof and a NMF component are blended together, the effects of preventing skin roughness and improving skin roughness are each independent. The present invention was found to be superior to the case of using the same, and the present invention was completed.

[0005] That is, claim 1 of the present invention is a cosmetic for improving skin roughness characterized by blending pyridoxine or a derivative thereof and an NMF component. A second aspect of the present invention is the cosmetic for improving rough skin, wherein the pyridoxine derivative is a pyridoxine hydrochloride according to the first aspect. Further, claim 3 of the present invention is the method according to claim 1 or 2, wherein the NMF component is a pyrrolidone carboxylate,
It is a cosmetic for improving skin roughness characterized by being one or a combination of two or more selected from amino acids and minerals (calcium, magnesium, sodium, potassium). In a fourth aspect of the present invention, the compounding amount of pyridoxine or a derivative thereof is 0.00
1 to 5% by weight and the compounding amount of the NMF component is 0.00
1 to 10% by weight of a cosmetic for improving skin roughness.

[0006]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described in detail.

Pyridoxine is a water-soluble vitamin involved in amino acid metabolism, and as its derivatives, dicapric acid ester, dipalmitic acid ester, tripalmitic acid ester, hydrochloride and the like are known. The pyridoxine or a derivative thereof used in the present invention may be any one, but is preferably pyridoxine hydrochloride having excellent water solubility. The NMF component includes pyrrolidone carboxylate, amino acids mainly containing serine, glycine, and alanine, lactic acid and lactate, urea, saccharides, and minerals mainly containing sodium, potassium, calcium, and magnesium. The NMF component used in the present invention may be any one, but is preferably a pyrrolidone carboxylate, an amino acid, or a mineral (calcium, magnesium, sodium, or potassium).

In the present invention, the amount of pyridoxine or a derivative thereof is preferably 0.001 to 5.0% by weight.
And more preferably 0.01 to 2.0% by weight. If the amount is less than 0.001%, the effect of improving skin roughness is not sufficient, and if the amount exceeds 5% by weight, no further effect is obtained.

The amount of the NMF component in the present invention is preferably 0.001 to 10% by weight, and more preferably 0.01 to 5% by weight. If the amount is less than 0.001% by weight, the effect of improving skin roughness is not sufficient, while the amount is 1%.
Even if it exceeds 0% by weight, no further effect can be obtained.

[0010] In addition to the above-mentioned constituents, the emulsified composition of the present invention may contain, if necessary, various kinds of components generally used in cosmetics. Examples of such components include oily components, surfactants, humectants, higher alcohols, sequestering agents, natural and synthetic polymers, water-soluble and oil-soluble polymers, ultraviolet absorbers, blood circulation promoters, and various extracts. , Inorganic and organic pigments, inorganic and organic clay minerals, inorganic and organic pigments treated with metal soap or silicone, coloring agents such as organic dyes, preservatives, antioxidants, pigments, thickeners, pH adjusters, Perfumes, cooling sensation agents, antiperspirants, bactericides, skin activators and the like can be mentioned.

Examples of the oil component include avocado oil, camellia oil, turtle oil, macadamia nut oil, corn oil, mink oil, olive oil, rapeseed oil, egg yolk oil, sesame oil, persic oil, wheat germ oil, southern oil, castor oil, linseed oil , Safflower oil, cottonseed oil, eno oil, soybean oil, peanut oil, teaseed oil, kaya oil, rice bran oil, sinagiri oil, Japanese kiri oil, jojoba oil, germ oil, triglycerin, glycerin trioctanoate, triisopalmitate Glycerin, cocoa butter, coconut oil, horse fat, hardened coconut oil, palm oil, tallow,
Sheep fat, hardened beef tallow, palm kernel oil, lard, beef tallow, mokuro kernel oil, hardened oil, beef tallow, mokuro, hardened castor oil, beeswax, candelilla wax, cotton wax, carnauba wax, bayberry wax, ibota wax, whale wax, Montan wax, bran wax, lanolin, kapok wax, lanolin acetate, liquid lanolin, sugar cane wax, isopropyl lanolin fatty acid, hexyl laurate, reduced lanolin, jojoba wax, hard lanolin, shellac wax, POE lanolin alcohol ether, POE lanolin alcohol acetate, P
Examples include OE cholesterol ether, lanolin fatty acid polyethylene glycol, POE hydrogenated lanolin alcohol ether, liquid paraffin, ozokerite, squalene, pristane, paraffin, ceresin, squalene, petrolatum, microcrystalline wax and the like.

Examples of the lipophilic nonionic surfactant include sorbitan monooleate, sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan sesquioleate, sorbitan trioleate, Diglycerol sorbitan penta-2-ethylhexylate,
Sorbitan fatty acid esters such as diglycerol sorbitan tetra-2-ethylhexylate, glycerin mono-cottonseed oil, glyceryl monoerucate, glyceryl monosteaoleate, glyceryl monostearate, glycerin α, α'-pyroglutamate oleate, glycerin monostearate Glycerin polyglycerin fatty acids such as malic acid; propylene glycol fatty acid esters such as propylene glycol monostearate; hydrogenated castor oil derivatives; glycerin alkyl ether;

Examples of the hydrophilic nonionic surfactant include POE sorbitan fatty acid esters such as POE sorbitan monooleate, POE-sorbitan monostearate, POE-sorbitan monooleate, POE-sorbitan tetraoleate, and POE-sorbitan. POE sorbit fatty acid esters such as sorbit monolaurate, POE-sorbit monooleate, POE-sorbit pentaoleate, POE-sorbit monostearate, POE-glycerin monostearate, POE-glycerin monoisostearate, POE- POE glycerin fatty acid esters such as glycerin triisostearate, POE monooleate, POE distearate,
POE fatty acid esters such as POE monodioleate and ethylene glycol cysteate, POE lauryl ether, POE oleyl ether, POE stearyl ether,
POE alkyl ethers such as POE behenyl ether, POE2-octyldodecyl ether, and POE cholestanol ether; POE such as POE octylphenyl ether, POE nonylphenyl ether, and POE dinonylphenyl ether
E Alkyl phenyl ethers, Pluronics such as bruronic, POE / POP cetyl ether, POE / PO
P2-decyl tetradecyl ether, POE / POP monobutyl ether, POE / POP hydrogenated lanolin, POE / POP alkyl ethers such as POE / POP glycerin ether, tetra POE / tetra POP ethylene diamine condensates such as tetronic, POE castor Oil, POE hardened castor oil, POE hardened castor oil monoisostearate, POE hardened castor oil triisostearate, POE hardened castor oil monopyroglutamic acid monoisostearate diester, POE hardened castor oil Maleic acid, etc. Oil derivatives,
POE bee wax and lanolin derivatives such as sorbitol beeswax, cocoanol fatty acid diethanolamide, lauric acid monoethanolamide, alkanolamides such as fatty acid isopropanolamide, POE propylene glycol fatty acid ester, POE alkylamine, POE fatty acid amide,
Sucrose fatty acid ester, POE nonylphenylformaldehyde condensate, alkylethoxydimethylamine oxide, trioleyl phosphoric acid and the like.

Examples of the anionic surfactant include soap base materials, fatty acid soaps such as sodium laurate and sodium palmitate, higher alkyl sulfates such as sodium lauryl sulfate and lauryl sulfate K,
Alkyl ether sulfates such as POE lauryl sulfate triethanolamine and POE sodium lauryl sulfate;
N-acyl sarcosine acids such as sodium lauroyl sarcosine, N-myristoyl-N-methyltaurine sodium,
Higher fatty acid amide sulfonates such as coconut oil fatty acid sodium methyl tauride and sodium lauryl methyl tauride, POE sodium oleyl ether phosphate, POE
Phosphate ester salts such as stearyl ether phosphoric acid, di-2
-Sulfosuccinates such as sodium ethylhexylsulfosuccinate, monolauroylmonoethanolamide sodium polyoxyethylene sulfosuccinate, sodium lauryl polypropylene glycol sulfosuccinate, sodium linear dodecylbenzenesulfonate, triethanolamine linear dodecylbenzenesulfonate, linear dodecylbenzenesulfone Alkyl benzene sulfonates such as acids, monosodium N-lauroyl glutamate, disodium N-stearoyl glutamate, N-acyl glutamates such as monosodium N-myristoyl-L-glutamate, and higher fatty acids such as hydrogenated coconut oil fatty acid sodium glycerin sulfate Ester sulfates, sulfated oils such as funnel oils, POE alkyl ether carboxylic acids, PO
E Alkyl allyl ether carboxylate, α-olefin sulfonate, higher fatty acid ester sulfonate, secondary alcohol sulfate, higher fatty acid alkylolamide sulfate, sodium lauroyl monoethanolamidosuccinate, N-palmitoyl asparagine Acid ditriethanolamine, sodium caseinate and the like.

Examples of the cationic surfactant include alkyltrimethylammonium salts such as stearyltrimethylammonium chloride and lauryltrimethylammonium chloride, distearyldimethylammonium dialkyldimethylammonium chloride, and poly (N, N'-dimethylchloride).
-3,5-methylenepiperidinium), alkylpyridinium salts such as cetylpyridinium chloride, alkyl quaternary ammonium salts, alkyldimethylbenzylammonium salts, alkylisoquinolinium salts, dialkylmorphonium salts, POE alkylamines, alkyl Amine salts, polyamine fatty acid derivatives, amyl alcohol fatty acid derivatives, benzalkonium chloride, benzethonium chloride,

Examples of the amphoteric surfactant include 2-undecyl-N, N, N- (hydroxyethylcarboxymethyl) -2-
Imidazoline amphoteric surfactants such as imidazoline sodium and 2-cocoyl-2-imitazolinium hydroxide-1-carboxyethyloxy disodium salt; 2-heptadecyl-N-carboxymethyl-N-hydroxyethylimidazolinium Betaine surfactants such as betaine, lauryl dimethylaminoacetate betaine, alkyl betaine, amido betaine, sulfobetaine and the like.

Examples of the humectant include propylene glycol, glycerin, 1,3-butylene glycol, xylitol, sorbitol, maltitol, chondroitin sulfate, hyaluronic acid, mucoitin sulfate, caronic acid, atelocollagen, cholesteryl-12-hydroxystearate, Examples include sodium lactate, bile salts, dl-pyrrolidone carboxylate, short-chain soluble collagen, adducts of diglycerin (EO) PO, extracts of Iris brassicae, extracts of St. John's wort and melilot extract.

Examples of the higher alcohol include straight-chain alcohols such as lauryl alcohol, cetyl alcohol, stearyl alcohol, behenyl alcohol, myristyl alcohol, oleyl alcohol, and cetostearyl alcohol, monostearyl glycerin ether (bacyl alcohol), and 2-decyltetradecyl alcohol. And branched chain alcohols such as knol, lanolin alcohol, cholesterol, phytosterol, hexyldecanol, isostearyl alcohol, octyldodecanol and the like.

As sequestering agents, for example, 1-hydroxyethane-1,1-diphosphonic acid, 1-hydroxyethane-1,1-diphosphonic acid tetrasodium salt, sodium citrate, sodium polyphosphate, sodium metaphosphate, Gluconic acid, phosphoric acid, citric acid, ascorbic acid,
And succinic acid, edetic acid and the like.

Examples of natural water-soluble polymers include, for example, arabia gum, tragacanth gum, galactan, guar gum, carob gum, karaya gum, carrageenan, pectin, agar, quince seed (quince), alge colloid (cassow extract), starch (rice, corn, Potato, wheat), plant polymers such as glycyrrhizic acid, microbial polymers such as xanthan gum, dextran, succinoglucan, burlan, collagen,
Animal-based polymers such as casein, albumin, and gelatin are exemplified.

As the semi-synthetic water-soluble polymer, for example,
Starch polymers such as carboxymethyl starch and methylhydroxypropyl starch, methylcellulose, nitrocellulose, ethylcellulose, methylhydroxypropylcellulose, hydroxyethylcellulose, cellulose sodium sulfate, hydroxypropylcellulose, sodium carboxymethylcellulose (CMC), crystalline cellulose, cellulose powder Cellulosic polymers such as
Alginic acid polymers such as sodium alginate and propylene glycol alginate are exemplified. As the synthetic water-soluble polymer, for example, polyvinyl alcohol, polyvinyl methyl ether, polyvinylpyrrolidone, and other vinyl polymers, polyethylene glycol 20,0
Polyoxyethylene polymers such as 00, 4,000,000 and 600,000, polyoxyethylene polyoxypropylene copolymer copolymer polymers, acrylic polymers such as sodium polyacrylate, polyethyl acrylate and polyacrylamide, polyethylene imine, And cationic polymers.

Examples of the inorganic water-soluble polymer include bentonite, AlMg silicate (Vegum), laponite,
Hectorite, silicic anhydride and the like.

As the ultraviolet absorber, para-aminobenzoic acid (hereinafter abbreviated as PABA), PABA monoglycerin ester, N, N-dipropoxy PABA ethyl ester, N, N-diethoxy PABA ethyl ester, N, N-dimethyl PABA ethyl ester Benzoic acid ultraviolet absorbers such as N, N-dimethyl PABA butyl ester; anthranilic acid ultraviolet absorbers such as homomenthyl-N-acetylanthranilate; amyl salicylate, menthyl salicylate, homomenthyl salicylate, octyl salicylate, phenyl salicylate ,
Salicylic acid UV absorbers such as benzyl salicylate and p-isopropanol phenyl salicylate; octylcinnamate, ethyl-4-isopropylcinnamate, methyl-2,5-diisopropylcinnamate, ethyl-2,4-
Diisopropyl cinnamate, methyl-2,4-diisopropyl cinnamate, propyl-p-methoxycinnamate, isopropyl-p-methoxycinnamate, isoamyl-p-methoxycinnamate, octyl-p-methoxycinnamate (2-ethylhexyl-p -Methoxycinnamate), 2-ethoxyethyl-p-methoxycinnamate,
Cyclohexyl-p-methoxycinnamate, ethyl-α
-Cinnamic acid ultraviolet absorbers such as cyano-β-phenylcinnamate, 2-ethylhexyl-α-cyano-β-phenylcinnamate, glyceryl mono-2-ethylhexanoyl-diparamethoxycinnamate; 2,4- Dihydroxybenzophenone, 2,2'-dihydroxy-4-methoxybenzophenone, 2,2'-dihydroxy-4,4'-dimethoxybenzophenone, 2,2 ', 4,4'-tetrahydroxybenzophenone, 2-hydroxy-4- Methoxybenzophenone, 2-hydroxy-4-methoxy-4'-methylbenzophenone, 2-hydroxy-4-methoxybenzophenone-5-sulfonate,
4-phenylbenzophenone, 2-ethylhexyl-4'-phenyl-benzophenone-2-carboxylate, 2-hydroxy-4-n-octoxybenzophenone, 4-hydroxy-3
-Benzophenone ultraviolet absorbers such as carboxybenzophenone; 3- (4'-methylbenzylidene) -d, 1-camphor, 3-benzylidene-d, 1-camphor, urocanic acid,
Urocanic acid ethyl ester, 2-phenyl-5-methylbenzoxazole, 2,2'-hydroxy-5-methylphenylbenzotriazole, 2- (2'-hydroxy-5'-t-octylphenyl) benzotriazole, 2 -(2'-Hydroxy-5'-
Methylphenylbenzotriazole, dibenzalazine,
Dianisoylmethane, 4-methoxy-4'-t-butyldibenzoylmethane, 5- (3,3-dimethyl-2-norbornylidene)-
3-pentan-2-one and the like.

Examples of the blood circulation promoting agent include nonylate valenylamide, nicotinic acid benzyl ester, nicotinic acid β-butoxyethyl ester, capsaicin, zingerone, cantharistinki, ittamol, caffeine, tannic acid, α-borneol, tocopherol nicotinate, Inositol hexanicotinate, cyclanderate, cinnarizine, tolazoline, acetylcholine, verapamil, cepharanthin, γ-oryzanol and the like.

Other pharmaceutical ingredients include vitamin A oil,
Retinol, retinol palmitate, inosit, benzyl nicotinate, nicotinamide, nicotinic acid DL
-Α-tocopherol, magnesium phosphate ascorbate, 2-O-α-D-glucopyranosyl-L-ascorbic acid, vitamin D2 (ergocasiferol), d
Vitamins such as l-α-tocopherol, dl-α-tocopherol acetate, pantothenic acid and biotin; hormones such as estradiol and ethinylestradiol; amino acids such as arginine, aspartic acid, cystine, cysteine, methionine, serine, leucine and tryptophan; Anti-inflammatory agents such as allantoin and azulene, whitening agents such as arbutin; astringents such as zinc oxide and tannic acid; L
-Cooling agents such as menthol and camphor; sulfur; lysozyme chloride;

As various extracts, dokudami extract,
Oak extract, melilot extract, bonito extract, liquorice extract, peonies extract, bonsai extract, loofah extract, kina extract, saxifrage extract,
Clara extract, Kouhone extract, Fennel extract, Primrose extract, Rose extract, Jiao extract, Lemon extract, Sikon extract, Aloe extract, Shobu root extract, Eucalyptus extract, Japanese cedar extract, Sage extract, Thyme extract, Tea extract, Seaweed extract, Cucumber extract, Clove Extract, raspberry extract, melissa extract, carrot extract, marronie extract, peach extract, peach leaf extract, mulberry extract, cornflower extract, hamamelis extract, placenta extract, thymus extract, silk extract, licorice extract and the like.

[0027]

Next, the present invention will be described with reference to examples, but the present invention is not limited to these examples.

Evaluation of Usability of Cosmetic for Improving Skin Roughness With respect to the emulsified compositions shown in the attached table, when the pyridoxine or its derivative and the NMF component are blended, the emulsified composition containing only one of them and the emulsion composition containing only one of them are also blended. Its usability was evaluated in comparison to a non-emulsified composition.

[Evaluation Method and Evaluation Criteria] Samples from Examples and Comparative Examples were continuously applied for 4 weeks (appropriate amount was applied to the face after washing the face in the morning and night) by 10 female panels who are likely to have rough skin to prevent rough skin and rough skin. The effect of the improvement was compared.

Evaluation of skin roughness prevention and skin roughness improvement effect A: 8 or more out of 10 panelists answered that skin roughness was improved and skin roughness was difficult ○; ○ ○ 6 to 7 out of 10 △; 〃 １０ 10 Medium 3-5 ×; 〃 ２ Less than 2 out of 10

Examples 1 to 6 and Comparative Examples 1 to 3 Emulsified compositions were prepared based on the following basic formulations, and their usability was evaluated.

(Basic prescription) ────────────────────────────────── Ethanol 3.0% by weight Glycerin 0 Carboxyvinyl polymer 0.2 Alkyl-modified carboxyvinyl polymer 0.1 POE (60) hydrogenated castor oil 0.2 Liquid paraffin 2.0 Jojoba oil 1.0 NMF component Pyridoxine derivative Triethanolamine 1.0 Edet Acid salt 0.05 Methyl paraben 0.2 Fragrance 0.05 Deionized water Residue ──────────────────────────────── ──

In the above basic formulation, the NMF component and the like were replaced with the components shown in Table 1, and the evaluation was performed. The results are shown in Table 1.

[0034]

[Table 1]

With respect to an emulsion composition containing an appropriate amount of a pyridoxine derivative and an NMF component, the roughening is improved and the skin becomes less likely to be roughened. It can be seen that the emulsified composition that has not been performed has insufficient effects of improving and preventing rough skin.

Example 7 O / W emulsion type emulsion (1) Dipropylene glycol 5.0% by weight (2) Glycerin 3.0 (3) PEG 1000 3.0 (4) Carboxyvinyl polymer 0.5 (5) Triethanolamine 1.0 (6) stearic acid 2.0 (7) sorbitan monooleate 2.0 (8) stearyl alcohol 1.5 (9) dimethylpolysiloxane (6cs) 5.0 (10) pyrrolidone carboxylic acid Sodium citrate 0.5 (11) Pyridoxine hydrochloride 0.3 (12) Disodium edetate 0.05 (13) Ethylparaben 0.2 (14) Fragrance 0.05 (15) Ion-exchanged water Residue Emulsified composition by ordinary method Was prepared. The obtained emulsified composition was excellent in preventing rough skin and improving rough skin.

Example 8 W / O emulsified emulsion (1) PEG 1500 3.0% by weight (2) dipropylene glycol 2.0 (3) potassium chloride 0.5 (4) edetate trisodium 0.1 ( 5) Diglyceryl diisostearate 0.5 (6) Polyoxyethylene modified dimethylpolysiloxane 1.0 (7) Octamethylcyclotetrasiloxane 25.0 (8) Decamethylcyclopentasiloxane 35.0 (9) Pyridoxine dicaprin Acid ester 0.05 (10) Serine 0.3 (11) Ethylparaben 0.3 (12) Fragrance 0.01 (13) Ion-exchanged water Residue An emulsified composition was prepared by a conventional method. The obtained emulsified composition was excellent in preventing rough skin and improving rough skin.

Example 9 O / W emulsification type cream (1) 1,3-butylene glycol 6.0% by weight (2) PEG 1500 10.0 (3) POE (25) cetyl alcohol ether 3.0 (4) Glycerin monostearate 2.0 (5) Cetyl alcohol 3.0 (6) Solid paraffin 2.0 (7) Vaseline 5.0 (8) Butyl paraben 0.2 (9) Sodium lactate 1.0 (10) Pyridoxine Dipalmitate 1.5 (11) Fragrance 0.3 (12) Carboxyvinyl polymer 0.2 (13) Trisodium edetate 0.4 (14) Deionized water Residue An emulsified composition was prepared by a conventional method. The obtained emulsified composition was excellent in preventing rough skin and improving rough skin.

[0039]

Industrial Applicability According to the present invention, it is possible to provide a cosmetic for improving skin roughness which is excellent in preventing skin roughness and improving skin roughness.

Continued on the front page (51) Int.Cl. ⁶ Identification code FI A61K 7/00 A61K 7/00 W

Claims (4)

[Claims] 1. A cosmetic composition for improving rough skin, comprising a pyridoxine or a derivative thereof and a natural moisturizing factor (hereinafter referred to as an NMF component) present in the skin stratum corneum. 2. The cosmetic for improving skin roughness according to claim 1, wherein the pyridoxine derivative is pyridoxine hydrochloride. 3. The method according to claim 1, wherein the NMF component is a pyrrolidone carboxylate,
3. The composition according to claim 1, wherein the composition is one or a combination of two or more selected from amino acids and minerals (calcium, magnesium, sodium, potassium).
The cosmetic for improving rough skin according to any one of the above. 4. The composition according to claim 1, wherein the compounding amount of pyridoxine or a derivative thereof is 0.001 to 5.0% by weight, and the compounding amount of the NMF component is 0.001 to 10% by weight. Item 4. The cosmetic for improving skin roughness according to any one of Items 3.