Human skin irritation test

Primary human skin irritation of tetradecanol, hexadecanol, and octadecanol is nil they have been used for many years ia cosmetic creams and ointments (24). Based on human testing and iudustrial experience, the linear, even carbon number alcohols of 6—18 carbon atoms are not human skin sensitizers, nor are the 7-, 9- and 11-carbon alcohols and 2-ethylhexanol. Neither has iudustrial handling of other branched alcohols led to skin problems. Inhalation hazard, further mitigated by the low vapor pressure of these alcohols, is slight. Sustained breathing of alcohol vapor or mist should be avoided, however, as aspiration hazards have been reported (25). 

Generally speaking, up to now the importance of a-sulfo fatty acid esters in cosmetic products has been low [1 p. 367], In the future they may become more interesting because of their mildness. a-Sulfomethyl laurate and most other ester sulfonates are mild to the skin also, they are not human skin sensitizers or primary skin irritants. Tests have shown that a-sulfomethyl laurate is mild enough to be in bath products, such as bubble bath [62]. Three patents for different applications are given to show how ester sulfonates can be used in cosmetics. 

Guinea pig tests Indicated that CS had a potential for producing human skin irritation and sensitization.38 39... 

Dermal. Dermal administration is required for estimation of toxicity of chemicals that may be absorbed through the skin, as well as for estimation of skin irritation and photosensitization. Compounds are applied, either directly or in a suitable solvent, to the skin of experimental animals after hair has been removed by clipping. Often dry materials are mixed with water to make a thick paste that can be applied in a manner that ensures adequate contact with the skin. Frequently the animals must be restrained to prevent licking and hence oral uptake of the material. Solvent and restraint controls should be considered when stress is involved. Skin irritancy tests may be conducted on either animals or humans, using volunteer test panels for human tests. 

York M, Basketter DA, Cuthbert JA, Nelson L (1995) Skin irritation testing in man for hazard assessment - evaluation of four patch systems. Human and Exper Toxicol 14 729-734 York M, Griffiths HA, Whittle E, Basketter DA (1996) Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis 34(3) 204-212... 

The principal distinction between transdermal and topical drugs is that only the former is intended for systemic delivery. Both are subject to the same skin irritancy testing prior to human exposures precli-nical and clinical skin irritancy testing is reasonably stereotypical and commodity priced. 

Jacobs GA, Castellazzi A, Dierickx PJ. 1989. Evaluation of a non-invasive human and an in vitro cytotoxicity method as alternatives to the skin irritation test on rabbits. Contact Derm 21(4) 239-244. 

As a next step, the formulation is tested using in vitro skin irritation tests such as the Zion test [16], collagen swelling test [17], or pH rise test [18], If the results of these tests show that the product is suitable for human clinical research, then it undergoes the following tests. 

Skin irritation test The skin irritation reaction is listed in table 5. Skin sensitization is an immunologically mediated reaction to a substance. In a human, the response can be characterized by pruritis, erythema, edema, papules, vesicles, bullae, or a combination of these. In other species, the reactions are different and only erythema and edema can be seen 14-15. The skin irritation reactions showed that there are no allergic responses, which indicated that the porous AI2O3 ceramics did not induce any immune reactions to guinea pigs. 

Jlrova, D., Basketter, D., Liebsch, M., Bendova, H., Kejlova, K., Marriott, M., Kandarova, H. (2010) Comparison of human skin irritation patch test data with in vitro skin irritation assays and animal data. Contact Dermatitis, 62 (2), 109-116. 

J. (2009) An in vitro skin irritation test (SIT) using the EpiDerm reconstructed human epidermal (RHE) model. J Vis Exp, (29), pii 1366. 

K. (2015) Development, optimization, and standardization of an in vitro skin irritation test for medical devices using the reconstructed human tissue model epiderm. Toxicologist, 144... 

Decades of experience have been obtained using the Draize dermal irritation test on albino rabbits, described in OECD guideline 404. However, the use of laboratory animals for skin irritation testing is decreasing due to the development of in vitro models (Ponec 1996) and more frequent use of human... 

Muller-Decker, K., Furstenberger, G., and Marks, F., 1992, Development of an in vitro alternative assay to the Draize skin irritancy test using human keratinocyte-derived proinflammatory key mediators and cell viability as test parameters. In Vitro Toxic. 5 191 - 209. 

Although sage oil contains more thujone than absinthium oil, it has not been reported to be toxic (see absinthium). Two recent studies, however, reported that the oil may be hepato-toxic at high concentrations. Dalmation sage oil has been reported to be nonirritating and nonsensitizing to human skin when tested in a diluted form. When applied undiluted, it produced one irritation reaction in 20 subjects and was moderately irritating to rabbits. ... 

Furthennore, some materials, including medical textiles, have the potential to cause allergy or irritation. The sensitization potential of the material is therefore required to be tested. The ISO 10993-10 assesses the possible contact hazards from chemicals released from the devices, which may produce skin, mucosal, or eye irritation and skin sensitization. Currently, there has been no satisfactory in vitro test to eliminate the requirement for in vivo testing to evaluate irritation. However, the rat skin Transcutaneous Electrical Resistance (TER) test and the human skin model test have been internationally validated and accepted as alternative tests to assess the skin corrosion with chemicals (OECD, 2009a,b). To perform the test, an animal (rabbit) with the healthy intact skin needs to be used and the fur on the back of animal is clipped 24-4h of testing with approximate size of 10cmX 15 cm and then 0.5g or 0.5 mL of materials apply to the site and then the application site is covered with... 

Consequently, the human skin model assays (e.g. EpiDeim and EPISKIN ) and the mouse SIFT appear to be the most promising in vitro methods for skin irritation testing. However, there is a need to develop new endpoints that are more predictive of skin irritation than simple cytotoxicity determinations. 

Katoh M, Hamajima F, Ogasawara T, Hata K. 2010. Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol. J. Toxicol. Sci. 34(3) 327. 

Health and Safety Factors. Results of acute oral toxicity studies of 2-pyrrohdinone on white rats and guinea pigs show the LD q to be 6.5 ml,/kg. Skin patch tests on 200 human subjects indicate that 2-pyrrohdinone is a skin kritant, but there is no indication of sensitising action. It is a mild eye irritant (79). 

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]. 

---