Biomedical subjects

J Stotts

Publications and source records attributed to J Stotts.

4 recordsLinked to original sources

PubMed1990

Allergic contact dermatitis from propyl gallate: dose response comparison using various application methods.

The antioxidant propyl gallate, in a deodorant product, caused an allergic contact dermatitis in 1 subject during developmental controlled use testing. Subsequent dose response elicitation studies with this subject revealed a differing threshold of sensitivity to propyl gallate dependent upon application method. Increasing the level of occlusion increased the elicitation response. Responsiveness from greatest to least was: occluded patch on the upper arm greater than semi-occluded axilla greater than open application on the antecubital fossa. The thresholds determined for propyl gallate (w/v in 25:75 ethanol:water) were: (a) 0.0025% for the upper arm occluded patch; (b) 0.0035% for the underarm without shaving; (c) 0.005% for the underarm with shaving; (d) 0.015% for the antecubital fossa. Occluded patch responsiveness to propyl gallate was monitored and remained unchanged throughout a 2-year period. These data are useful in understanding the relationship between occlusive allergic contact dermatitis patch testing and clinical contact dermatitis.

Administration, Cutaneous↗

PubMed1989

A risk assessment process for allergic contact sensitization.

This review describes an approach that has been used to assess the skin sensitization risk of new chemicals and product formulations prior to launching the new chemical or product on the market. The risk assessment process utilizes a comparative toxicological approach, in which data on the inherent toxicity of a material, and the exposure to it through manufacturing or consumer use or foreseeable misuse, are integrated and compared with data generated by 'benchmark' materials of similar chemistry or product application, or both. This approach has been valuable in providing an accurate assessment of the skin sensitization potential for a wide range of consumer products and pharmaceuticals, ranging from products with a very transient skin exposure (e.g. some paper products), to cosmetics, to products whose ingredients may be deposited on fabrics and thus result in chronic skin exposure. The risk assessment process described includes both guinea-pig (Buehler) and human skin sensitization test methodologies to evaluate inherent toxicity under relevant epicutaneous exposure conditions. Alternative guinea-pig test methods have been reported to be more sensitive than the Buehler method, particularly those employing intradermal injection of the test material in Freund's complete adjuvant (e.g. maximization test). However, by bypassing the skin barrier at induction, these methods can overstate the sensitization risk of epicutaneous exposure to weak sensitizers (Andersen and Hamann, 1983 and 1984; Matsushita et al., 1975a,b), and can understate the risk to very strong sensitizers possibly through tolerance induction (Buehler, 1985). In addition, materials are tested and classified at concentrations that may not be relevant to anticipated human exposure. The Buehler guinea-pig test data are important in assessing skin sensitization risk in the early phases of product development, where human exposure can be limited, controlled and monitored (e.g. manufacturing employees). The Buehler test can often define consumer skin sensitization risk; however, the ultimate consumer skin safety assessment should in general be developed through a series of controlled human tests; the human repeat insult patch test and, when necessary, the provocative or extended product use tests. Post-market monitoring of skin-related consumer comments is the final phase of the data gathering process. These results can be used to assess further each product and to provide valuable feedback to confirm the validity of the overall risk assessment process. Risk assessment for skin sensitization potential is seldom a simple process.(ABSTRACT TRUNCATED AT 400 WORDS)

Consumer Product Safety↗

PubMed1987

Luteinizing hormone and progesterone concentrations in serum of heifers administered a short half-life prostaglandin (PGF(2alpha)) or long half-life prostaglandin analogue (fenprostalene) on days six or eleven of the estrous cycle.

Two trials were conducted to measure the progesterone (P(4)) decline and luteinizing hormone (LH) surge in serum subsequent to administration of a short half-life (short t (1 2 )) prostaglandin (PGF(2alpha)) or a long half-life (long t (1 2 )) prostaglandin analogue (fenprostalene) on Days 6 or 11 of the estrous cycle. Twenty-five crossbred Shorthorn and five Hereford heifers with a mean weight of 331.4 +/- 29.8 kg were used in both trials. The heifers were randomly allotted to receive either a short t (1 2 ) or long t (1 2 ) prostaglandin treatment on Day 6 or 11 of the estrous cycle. A crossover design for the main effect, treatment (type of prostaglandin), was conducted. Heifers that received PGF(2alpha) in Trial I were given fenprostalene in Trial II and vice versa. Stage of the estrous cycle (day) was the same for each heifer in both trials. Stage of estrous cycle was standardized to either Day 6 or 11 by administering Syncro-Mate B (SMB). Blood was collected every hour for 80 h post injection to quantify LH and P(4) concentrations. There were no significant differences (P > 0.05) between the short t (1 2 ) or long t (1 2 ) for either P(4) or LH profiles. In addition, no differences were detected between stages of the estrous cycle for the timing of the preovulatory surge of LH after prostaglandin administration.

Journal Article↗

PubMed1977

Induction of human skin sensitization to ethanol.

In predictive skin sensitization tests, 50% aqueous ethanol induced delayed allergic skin reactivity in 6 of 93 human volunteers. This was confirmed 2 months after the primary challenge by producing an allergic response in each of the 6 with a single 24-hr application of 50% aqueous ethanol. Three of these reactive subjects also responded to lower concentrations of ethanol in water, and 2 of them still showed allergic reactivity 18 months later. Possible allergens other than the ethanol itself (i.e., an impurity or an ethanol-soluble component of the patch) were eliminated. Responses of 1 subject to ethanol that had been purified by gas chromatography confirmed that ethanol alone was the sensitizer. This subject also reacted to other short-chain primary alcohols, a secondary alcohol, and acetaldehyde, suggesting an antigenic relationship among all of these compounds in the skin. One of the authors, who had become sensitized to acetaldehyde, showed a similar pattern of cross-reactivity. Previous infrequent reports of ethanol sensitivity have been limited to case studies and diagnostic patch testing. This work provides evidence that a test designed to predict skin-sensitizing potential will identify even a weak sensitizer such as ethanol. Aqueous ethanol solutions approaching 50% concentrations should be avoided as vehicles in human predictive sensitization testing.

Acetaldehyde↗