Human patch test

Neoprene Type TW was shown to have low oral toxicity in rats. The LD q was found to be in excess of 20,000 mg/kg. Human patch tests with Types GN, W, WRT, and WHV showed no skin reactions (169). The FDA status of Du Pont Neoprene polymers is described (172). Although polychloroprene itself has not been shown to have potential health problems, it should be understood that many mbber chemicals that may be used with CR can be dangerous if not handled properly. This is particularly tme of ethylenethiourea curatives and, perhaps, secondary amine precursors often contained in sulfur modified polychloroprene types. Material safety data sheets should be consulted for specific information on products to be handled. 

Van Paassen [57,67] reported a synergistic decrease of the skin and eye irritation level of sodium lauryl ether sulfate by combination with lauryl ether carboxylates. The investigations have been carried out using the Draize eye irritation test and human patch test (Tables 13 and 14). Furthermore, measurements by in vitro methods, the Zein test, and the red blood cell test show low to no irritancy [251-253]. 

FIG. 7 Skin irritation according to the human patch test of alkyl ether carboxylic acids compared to other mild cosurfactants. CFTA-names 1, cocamidopropylbetaine 2, sodium PEG-6 cocamide carboxylate 3, sodium laureth-11 carboxylate 4, cocoamphocarboxypropionate 5, protein hydrolyzate 6, disodium laureth-3 sulfo-succinate SLES, sodium laureth sulfate. (From Ref. 68.)... 

CNTs Arc discharge Human Patch test 96 h None [50]... 

In three cases of acute human exposure from industrial accidents, symptoms included light-headedness, drowsiness, anxiety and apprehension, and nausea slurred speech and vomiting also occurred in one case. In human patch tests, a 23% solution caused severe irritation and possible sensitization. However, guinea pig sensitization tests did not confirm a potential for sensitization. ... 

Voss W, Dermatest GmbH, Munster, Germany (2004) Report on a Human Patch Test... 

York, M., Griffiths, H.A., Whittle, E., and Basketter, D.A. Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis 1996 34 204—212. 

Basketter, D.A., Griffiths, H.A., Wang, X.M., Wilhelm, K.-P., and McFadden, J. Individual, ethnic and seasonal variability in irritant susceptibility of skin the implications for a predictive human patch test. Contact Dermatitis 1996 35 208-213. 

Allergens can cause vastly different responses in individuals or the allergic response is very individualized. Nevertheless, this method will identify the majority of skin-sensitizing chemicals and has shown good agreement with human patch tests (Schneider and Akkan 2004). 

Shelanski HA (1951) Experience with and considerations of the human patch test method. J Soc Cosmet Chem 2 324—331 Shelanski HA, Shelanski MV (1953) Anew technique ofhuman patch tests. The Proceedings of the Scientific Section of the Toilet Goods Association 19 46-49 Stotts J (1980) Planning, Conduct, and Interpretation of Human Predictive Sensitization Patch Tests. In Current Concepts in Cutaneous Toxicology. Academic Press, Orlando, 41-53... 

Opdyke DL, Burnett CM (1965) Practical problems in the evaluation of the safety of cosmetics. Proceedings of the Scientific Section of the Toilet Goods Association 44 3 1 Opdyke D (1971) The guinea pig immersion test A 20 year appraisal. CFTA Cosmetic J 3 46—47 Phillips L, Steinberg M, Maibach HI, Akers WA (1972) A comparison of rabbit and human skin response to certain irritants. Toxicol Appl Pharmacol 21(3) 369-382 Uttley M, Van Abbe NJ (1973) Primary irritation of the skin Mouse ear test and human patch test procedures. J Soc Cosmet Chem 24 217-227... 

Lanman BM, Elvers WB, Howard CS (1968) The role of human patch testing in a product development program. Proceedings of the Joint Conference on Cosmetic Sciences. The Toilet Goods Association, Washington, DC, pp 135-145 Rapaport M, Anderson D, Pierce U (1978) Performance of the 21-day patch test in civilian populations. J Toxicol Cut Ocular Toxicol 1 109-115... 

Smiles KA, Pollack ME (1977) A quantitative human patch testing procedure for low level skin irritants. J Soc Cosmet Chem 26 755-764... 

When it is ethical to perform human patch testing ... 

In Japan, Uchiyama has recently published requirements for the safety evaluation of new excipients. These requirements include studies on acute, subacute, and chronic toxicity, mutagenicity, effects on reproduction, dependency, antigenicity, carcinogenicity, and local irritation (human patch test). The first five of these tests are mandatory. With the exception of the local irritation test, for which a domestic trial is required, non-Japanese data are acceptable for these studies. Even if a material has been used in a pharmaceutical product outside Japan, the material is treated as a new excipient if there has been no prior use in Japan, although relevant overseas data for the material are acceptable for regulatory submission. A material is treated as a new excipient when the route of administration differs or the dose level exceeds that of prior use even after approval for the Japanese market.f ... 

Human patch test, Dermal 1 % soln (3.7% of 1619 patients Kiec-Swierczynska... 

Human patch test. Dermal 2% soln (1.6% of 1081 patients Meding and... 

As this approach did not differentiate between weak and strong sensitizers, IFRA subsequently adopted a modified approach. The IFRA technical advisory committee studied the results of the human patch tests, and if necessary asked for further work to be undertaken, to see if a no effect level could be determined for each material. If such a level could be determined, the committee set a guideline value that allowed only one-tenth of the no effect level to be used in a consumer product. Obviously, in some cases this level was below that at which the ingredient made any useful contribution to the fragrance and IFRA recommended a complete ban. However, it did allow many useful... 

In human patch tests, ylang ylang essential oil tested at concentrations between 0.2 and 10% elicited positive skin reactions in 1.3 to 6.2% of volunteers in different testing centers (Frosch et al. 2002). 

Garaway seed oil was nonirritating when applied for 48 hours at a concentration of 4% in human patch tests (Opdyke 1979). 

In sensitization tests with fragrance raw materials, several volunteers that tested positive to patch tests with a fragrance mix also tested positive to lime extract (Roesyanto-Mahadi et al. 1990). Lime essential oil demonstrated phototoxic activity in human patch tests (Opdyke 1979). 

Kejlova, K., D. Jirova, H. Bendova, et al. 2007. Phototoxicity of bergamot oil assessed by in vitro techniques in combination with human patch tests. Toxicol. In Vitro 21(7) 1298-1303. 

No irritant activity of 4% cardamom essential oil in petrolatum base was observed in 48-hour closed human patch tests (Opdyke 1979). In sensitization testing, no sensitization reactions were observed after testing with 4% cardamom essential oil in petrolatum base (Opdyke 1979). 

Several randomized studies with humans have been realized a human patch test for 72 h and a repetitive epicutaneous test for 6 weeks, as well as tests on the influence of nanocellulose on the moistness of the skin after short-term treatment (20 min, measuring of moistness up to 12 h after treatment). The results demonstrate that the applied nanocellulose will not cause any unwanted skin reactions due to irritating, sensitizing, or early allergic effects and the moistness of the treated... 

Some dry polychloroprene types have been shown to have low oral toxicity rates. Human patch test for several dry types showed no skin reactions (142). The FDA status of Neoprene polychloroprene is described in the literature (143). 

Human patch test for mildness (0.25%, 0.50%, 0.75% actives) Mild Mild... 

CAS 629-70-9 61788-49 EINECS/ELINCS 211-103-7 262-980-8 Uses Emollient, lubricant, moisturizer, penetrant, plasticizer, cosolvent, solubilizer, emulsifier for personal cate prods., pharniaceuticals hair and skin softener and conditioner vehicle for medicaments degteaser and detackifier for emulsions Properties Cl. to yel. Ilq., char, bland odor Insol. in water sol. in min. oil, castor oil, veg. oil, alcohol sp. gr. 0.850-0.880 b.p. 450 F acid no. 1 max. iodine no. 10 max. sapon. no. 180-200 hyd. no. 8 max. flash pt. (COC) 340 C 100% cone. Toxicology LD50 (acute toxicity, rats) > 5 g/kg skin (50% sol n.) nonirritating and nonsensitizing in a 50 subject human patch test panel. 

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