GB 17149.2-1997 Diagnostic criteria and treatment principles for cosmetic contact dermatitis
Some standard content:
GB17149.2-1997
This standard is specially formulated to cooperate with the implementation of the Regulations of the People's Republic of China on Hygiene Supervision of Cosmetics. The diagnostic criteria and treatment principles specified in this standard only involve irritant contact dermatitis and allergic contact dermatitis caused by cosmetics. This standard shall be implemented from December 1, 1998.
Appendix A and Appendix B of this standard are appendices to the standard. Appendix C and Appendix D of this standard are indicative appendices. This standard is proposed by the Ministry of Health of the People's Republic of China. Drafting units of this standard: PLA Air Force General Hospital, Second Affiliated Hospital of Dalian Medical College, First Affiliated Hospital of Nanjing Medical College, Peking Union Medical College Hospital,
Main drafters of this standard: Huang Gan, Li Ruikang, Liu Wei, Zhao Bian, Yuan Zhaozhuang. This standard is interpreted by the Chinese Academy of Preventive Medicine, the technical management unit entrusted by the Ministry of Health. 425
National Standard of the People's Republic of China
Diagnostic criteria and principles of managementof contact dermatitis induced by cosmeticsGB17149.2—1997
Cosmetic contact dermatitis refers to irritant contact dermatitis and allergic contact dermatitis caused by contact with cosmetics. 1 Scope
This standard specifies the diagnostic criteria and management principles of cosmetic contact dermatitis. This standard applies to irritant contact dermatitis and allergic contact dermatitis caused by cosmetics. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards are subject to revision, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB17149.1—1997 General principles for the diagnosis and treatment of cosmetic skin diseases 3 Diagnostic principles
There is a clear history of contact with cosmetics, and the diagnosis is made based on the site of onset, the shape of the rash, and, if necessary, a skin patch test for comprehensive analysis, but contact dermatitis not caused by cosmetics needs to be excluded. 4 Diagnostic criteria
4.1 Irritant contact dermatitis
4.1.1 There is a clear history of contact with cosmetics, and dermatitis changes occur quickly after contact. 4.1.2 The lesions are limited to the contact site and have clear boundaries. 4.1.3 Under the same conditions, more people with contact usually develop the disease. 4.1.4 The lesions often present as acute or subacute dermatitis, with varying degrees of erythema, papules, edema, and blisters. After rupture, there may be erosion, exudation, and induration. The local lesions are conscious of itching, burning, or pain. The severity of the lesions is clearly related to the concentration and contact time of the contacted substance. 4.1.5 When it occurs on the oral mucosa, there may be dryness, desquamation, local itching or burning pain. 4.1.6 It will heal quickly after the cause is removed.
Exclude the lesions caused by other factors other than cosmetics contact. 4. 1.7
4.2 Allergic contact dermatitis
4.2.1 There is a clear history of using or repeatedly using cosmetics, and there is a certain incubation period. 4.2.2 Among the people who use the same kind of cosmetics, generally only a few people will get sick. 4.2.3 The primary site is limited to the contact site, but it can spread to the surrounding area or distant sites. 4.2.4 The skin lesions have various forms and are itchy. It can manifest as dermatitis, erythema and scaling, redness and swelling of the head and face, periocular dermatitis with conjunctivitis, sweat herpes-like on the palms and fingers, and measles-like manifestations such as contact. Approved by the State Administration of Technical Supervision on December 15, 1997. 426
Implemented on December 1, 1998
GB17149.2-1997
4.2.5 The oral mucosa may show redness, swelling, exudation, crusting, erosion, etc. When the disease lasts for a long time, there may be chronic dermatitis changes such as moistening and thickening. 4.2.6 Skin lesions often persist and do not heal.
4.2.7 Spot tests often give positive results, see Appendix A. 4.2.8 Exclude other lesions caused by contact factors other than cosmetics. 4.2.9 For those with negative spot test results, open skin tests may be performed if necessary, see Appendix B. 5 Treatment principles
5.1 Remove cosmetics left on the skin promptly. 5.2 Stop using cosmetics that cause lesions or are suspected of causing lesions. 5.3 Symptomatic treatment according to the treatment principles of dermatitis-eczema. 427
GB 17149. 2--1997
Appendix A
(Appendix to the standard)
Skin patch test method
A1 This method is suitable for finding irritants or allergens of contact dermatitis caused by cosmetics. A2 When conducting skin patch test, the dilution concentration and diluent of the test object can be found in Appendix A of GB17149.1-1997. A3 Operation steps
A3.1 Mark the order of the patch tester (standard Finnish chamber). A3.2 Dilute the cosmetics to the specified concentration according to the variety or add the order of the cosmetic series allergens to the patch tester. The amount of patch test substance used is about 0.03g for creams and creams. If the allergen is liquid, first put a filter paper in the chamber, and then add the allergen (about 0.02~0.04mL); the control patch tester only uses the cosmetic diluent. A3.3 Apply the patch tester with allergens to the upper back or forearm with tape, and gently press it several times with the palm of your hand to make it evenly applied to the skin.
A4 Observation and judgmentbzxZ.net
A4.1 Observation time: Remove the patch test tape 48 hours after patch application, and wait for 30 minutes until the indentation of the patch tester disappears to determine the intensity of the reaction. If the result is negative, in order to avoid missing delayed reactions, the results can be observed again at 72 hours and 96 hours respectively. A4.2 Determination of the degree of reaction of the test site
No reaction on the skin
Skin is pale red, no infiltration
Skin is erythematous, diffusely moist, papules
Skin is erythematous, edematous, papules, small blisters Skin has large blisters on erythematous and edematous (-)
A5 Precautions
A5.1 Patch test is not suitable for acute stage of dermatitis. During the test, the subjects should avoid taking anti-inflammatory mediator drugs such as corticosteroids, antihistamines, etc.
A5.2 Before the patch test, the significance and possible reactions should be explained to the subjects in order to obtain cooperation. A5.3 If the test site feels severe burning or itching, the patch test substance can be removed in time. During the patch test, keep the local area dry, do not move the patch tester to prevent it from falling off, and do not take a bath. A5.4
A5.5 Skin patch test is not suitable for summer. Appendix B
(Standard Appendix)
Open patch test method
B1 Indications
Open patch test is applicable to (1) patients with allergic contact dermatitis suspected to be caused by cosmetics but with suspicious or negative patch test results; (2) unknown or new allergic antigens.
B2 Operating steps
Apply the test substance (about 0.3g for creams and about 0.3mL for liquids) to a skin area of about 5cm×5cm near the antecubital fossa on the flexor side of the forearm, twice a day for seven consecutive days.
3 Observation and judgment
GB 17149. 2—1997
Observe the local skin reaction every day. No reaction is negative and dermatitis is positive. B4 Precautions
B4.1 If any irritation occurs during the test, stop at any time. B4.2 Most reactions occur within 4 days of use, and a few slow reactions may occur on the 5th to 7th day, so it is advisable to observe for a week. B4.3 Avoid washing and rubbing the local skin during the test period. Appendix C
(Suggested Appendix)
Common allergens of cosmetic dermatitis and their patch concentrations Table C1
Common substances
α-amyl-cinnamaldehydeα-naphthol
Eucalyptus oil
Ammoniated mercuryBenzyl alcohol
Benzaldehyde
Balsam of Peru
Peppermint oil
Benzophenones
Benzalkonium chloride (in water)Benzotriazole
Propylene glycol
Oxalic acid and its esters and alkaline salts acid,its esters and alkaline salts）Orange oil
Eugenol
Clove oil
Butyl hydroxytduene (BHT)Butyl hydroxyamisole (BHA)Tetracaine hydrochloride zamethocaineMethyl parahydroxybenzoateEthyl parahydroxybenzoatePropyl parahydroxybenzoateButyl parahydroxybenzoateBenzyl parahydroxybenzoateParatertiary butylphenolP-aminobenzoic acid (p-aminobenzoic acid p-aminophenol
patch test concentration, %
p-phenylenediamine GB 17149.2—1997
Table C1 (continued)
Common substances
paratertiary butylcatechol 2-chloro-N-hydroxy methyl-acetamide Selenium disulphide Disperse orange 3 C1 11005 Disperse yellow 3
Disperse red 1
Disperse red 17
Disperse blue 3 C1 61505 Phenol and its alkali salts salts）bacitracin
mercury
hydrogen peroxide(Hydrogen peroxide)benzoyl peroxide(Benzoyl peroxide)turpentine peroxide(Turpentine peroxide)anisyl alcohol
methanol
formaldehyde
resorcinol(Resorcinol)pyrogallol,1,2,3-pyrogallol(Imidazolidinyl urea igermall 115)germall 2(Diazolidinyl urea)N-[1,3-bis(hydroxymethyl)-2,5-dioxo-4-imidazolidinyl-N,N-bis(hydroxymethyl)urea]farnesol
polyoxyethylene sorbitan monopalmitate(Polyoxyethylene sorbitin monopalmitate Polyoxyethylene sorbitan monooleate Oak moss absolute Kathon CG (in water) Nerali oil
Musk ambrette
Clioguind, chinoform Quinine and its salts Lidocaine hydrochloride 6-methylcoumarin Copper sulphate (in water) Thiomersal
Quaternium-15 Chlorocresol (PCMC)
Chloroxylenol (PCMX) Chlorhoxidinedigluconate Chloramine T ( T)
Patch test concentration, %
Chloracetamide
ChlorqainaldolHalquinol
Jasmine
Rose oil
Lemon grass oil
Lemon oil
Boric acid
HydroxycitronellalHydroguinoneCinnamyl aldehyde
Cinnamyl alcohol
Benzyl cinnamateArnica tincture
Sorbic acid
GB 17149.2—1997
Table C1 (continued)
Common
sorbitan sesquioleate trolamine (triethanolamine) triclosan
salicylaldehyde
salicylic acid
phenyl salicylate water-based violet 201 (V-201) C1 60725
benzyl salicylate eosin, tetrabromofluorescein (eosine)
cety/stearyl alcohol sodium lauryl sulfate balsam of pine)
rosin
sudan I
storax
sandalwood oil
balsam of tolu
alpha amyl cinnamic alcoholglutardialdehyde
cinchocaine hydrochloridebronopol
pheny lmercuric nitrate (in water)vanillingeraniol
cedarwood oil
patch test concentration, %
lavender oil oil)
Pigment Yellow 204 (Y-204) C147000
Pigment Red 219 (R-219) C115800
Pigment Red 226 (R-226) C173360
Pigment Red 404 (R-404) C112315
Pigment Red 221 (R-221) C112120
Procaine hydrochloride GB 17149. 2--1997
Table C1 (end)
Common substances
Thiamine hydrochloride (Vit.B1) Pyridoxine hydrochloride (Vit. B6) Lanolin
Lanolin alcohol
1-dodecylguanidinium acetate 1,3,5-tris(2-hydroxyethyl)-hexahydrotriazine 1,3.5-tris(2-hydroxyethyl)-hexahydrotriazine Phenylmercuric acetate (in water) Ethylmercuric thiosalicylate (tionersal) Isothiazolium compounds Isoeugenol
Hexyl resorcinol Cananga oil
Liquid paraffin and lanolin alcohol (amercholL101) Eucerin
Lauryl oil Oil）
Balsam of spruce
Appendix D
(Appendix of tips)
Appendix of correct use standards
Patch test concentration, %
D1 Contact dermatitis is one of the common skin diseases in clinical practice. When diagnosing cosmetic contact dermatitis, similar lesions caused by other reasons should be excluded. In addition, it is also necessary to make a differential diagnosis with other inflammatory skin diseases such as eczema, seborrheic dermatitis, chronic lupus erythematosus, polymorphous light eruption, hand sweat herpes, contact urticaria, etc. D2 Skin patch test is one of the important bases for assisting in the diagnosis of cosmetic contact dermatitis. Those with positive test results can be diagnosed as cosmetic contact dermatitis; those with negative test results should be comprehensively analyzed in combination with medical history and clinical manifestations. If necessary, skin open test should be carried out, see Appendix B. D3 Cosmetics with irritation (such as hair removal and deodorant products) should not be subjected to skin patch test. Diagnosis can be made based on medical history and typical clinical manifestations.
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