Cosmetics testing

Taking the history of the patient and noting the clinical symptoms and localization of the lesions are critical. Allergen identification for a patient with a possible contact allergy to cosmetics is performed by means of patch testing with the standard series, specific cosmetic-test series, the product itself, and all of its ingredients. We can only find the allergens we look for. For skin tests with cosmetic products... 

Tomar J, Jain VK, Aggarwal K, et al. Contact allergies to cosmetics Testing with 52 cosmetic ingredients and personal products. J Dermatol 2005 32 (12) 951—5. 

Eskes C., Bessou S, Bruner L, Curren R, Harbell J, Jones P., Kreiling R, Liebsch M, McNamee P, Pape W, Prinsen M, Seidle T, Vanparys P, Worth A, Zuang V (2005). Subchapter 3.3. Eye irritation. In Eskes C, Zuang V (eds) Alternative (non-animal) methods for cosmetics testing current status and future prospects. ATLA 33(1), 47-81... 

Another important source of information on the status of alternative test development, with particular emphasis on the requirements for cosmetics testing, is a review paper published in 2011 by Adler and coauthors [9], Table 1 summarizes those relevant for reproductive toxicity. Several assays refer to the detection of endocrine effects on steroidogenesis based on a variety of cell types, and, as already mentioned, they will be dealt with in another chapter of this book. The other tests can be subdivided in placental toxicity/transport, preimplantation toxicity, female and male toxicity, and developmental toxicity. The tests that are suitable for detecting developmental toxicity include the EST, the whole-embryo assay, the micromass test (all three already described above), the zebrafish embryo teratogenicity assay, and the frog embryo teratogenesis assay (FETAX). 

Adler S, Basketter D, Creton S, Pelkonen O, van Benthem J et al (2011) Alternative (nonanimal) methods for cosmetics testing current status and future prospects-2010. Arch Toxicol 85 367-485... 

Alternative (non-animal) methods for cosmetics testing current status and future prospects—2010. Arch Toxicol 85 367M 85... 

Experiments with model porous silicon powders and membranes prepared by anodization are summarized in this review. Although such studies have shown the potential of porosified silicon in selected applications, these cosmetic tests will need to be repeated with less expensive forms, such as those derived from biogenic silicas (Batchelor et al. 2012),if the promising technical effects seen are to be translated into commercial products. The creation of cosmetic-grade porous silicon from plants looks particularly attractive, since there is great consumer interest in botanically derived actives and formulations. 

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). 

Microscopy (qv) plays a key role in examining trace evidence owing to the small size of the evidence and a desire to use nondestmctive testing (qv) techniques whenever possible. Polarizing light microscopy (43,44) is a method of choice for crystalline materials. Microscopy and microchemical analysis techniques (45,46) work well on small samples, are relatively nondestmctive, and are fast. Evidence such as sod, minerals, synthetic fibers, explosive debris, foodstuff, cosmetics (qv), and the like, lend themselves to this technique as do comparison microscopy, refractive index, and density comparisons with known specimens. Other microscopic procedures involving infrared, visible, and ultraviolet spectroscopy (qv) also are used to examine many types of trace evidence. 

In 1962, amendments to the U.S. Federal Food, Dmg and Cosmetic Act (Kefauver-Harris amendments) promulgated regulations concerning the requirements for premarketing approval by the FDA. This legislation estabUshed requirements of proof of both safety and therapeutic efficacy and strict control of human clinical testing, for example, which have extended the time and cost to market a new dmg. Thus, whereas approximately 40 new dmgs were marketed annually from 1948 to 1962, this number had fallen to 12 by 1966. 

The Federal Food, Dmg and Cosmetic (FDAC) Act defines dmgs as "...articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..." and "articles (other than food) intended to affect the stmcture of any function of the body of man." In the United States and elsewhere, the introduction of a new dmg is subject to a sequence of weU-defined stages of development and approval (4). Each stage involves either scientific testing or submission and preparation of data and analysis review (Fig. 2). 

Because they are similar, the aLkanolamines often can be used interchangeably. However, cost/perfomiance considerations generally dictate a best choice for specific appHcations. AMPD is manufactured in very low volumes for use as a reagent in certain medical diagnostic tests, although some is used in certain cosmetic products. 2-Ainino-1-butanol is used primarily as a taw material for the synthesis of ethambutol [74-55-5] an antituberculosis dmg. The first step in the synthesis of this dmg is the resolution of AB into its optical isomers because only (i)-2-amino-l-butanol, [5856-62-2] is utilized in this synthesis. 

Teratogenic effects have been noted with 2- and 4-aminophenol in the hamster, but 3-aminophenol was without effect in the hamster and rat (129,130). 4-Aminophenol is known to inhibit DNA synthesis and alter DNA stmcture in human lymphoblasts (131,132) and is mutagenic in mouse micronuclei tests (133). The aminophenols have been shown to be genotoxic, as evidenced by the induction of sister chromatid exchanges (134,135), but they also exert a protective effect against DNA interaction with other noxious chemicals (136). After assessment of available data a recent report stated that the aminophenols were safe as cosmetic ingredients in their present uses and concentrations (137). 

Specifications and Standards Test Methods. Ethylcellulose is cleared foi many apphcations in food and food contact under the Eedeial Eood, Dmg, and Cosmetic Act, as amended. Examples include binder in dry vitamin preparations for animal feed, coatings and inks for paper and paperboard products used in food packaging, and closures with sealing gaskets for food containers (44). Methods of analyses ate given in ASTM D914-72 (19), NationalFonmila XIV, and Food Chemicals Codex II. 

Economic summaries of the cosmetic industry, commonly documented by sales volume, are sometimes based on unit sales, sometimes on manufacturers sales in monetary units, and sometimes on consumer spending. Figures normally include contributions by private labeling operations but do not necessarily reflect the value of the industry service sector, which includes suppHers of raw materials, beauticians, testing laboratories, and other speciaHsts. Moreover, product categories caimot be rigidly defined. For example, the differentiation between a deodorant (a cosmetic) and an antiperspirant (an OTC dmg) is often obscured by its trade name. 

Hair colorants, the fourth class of color additives, may be used only to color scalp hair and may not be used in the area of the eye. Use of these colorants is exempt, that is, coal-tar hair dyes may be sold with cautionary labeling, directions for preliminary (patch) testing, and restrictions against use in or near the eye. The EDA diligently enforces the rules governing color additives and limits the use of, or even dehsts colorants deemed unsafe. The Hst of substances specifically prohibited for use in cosmetics is short. 

Safety testing of a finished cosmetic product should be sufficient to ensure that the product does not cause irritation when used in accordance with directions, neither eUcits sensitization nor includes a sensitizer, and does not cause photoaHergic responses. Some of the methods for determining animal or human responses to cosmetics are noted in Table 3. 

Performance. Consumer acceptance is a criterion on which cosmetic marketers caimot compromise. Whereas the likes and dislikes of consumers are in a state of constant flux, some product features are critical. A deodorant that does not deodorize or a hair coloring that fades in sunlight is unacceptable. Performance is tested by in vitro techniques during formulation, but the ultimate test of a product s performance requires in-use experience with consumers and critical assessment by trained observers. Performance tests can sometimes be combined with in-use safety tests, and protocols for such programs have been developed. 

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