Abstract  49 substances permitted for use in food in the United States was tested for mutagenicity in the Ames Salmonella typhimurium assay and in Escherichia coli strain WP2. Four of these substances caused increases in revertant counts in S. typhimurium. Two of these four (papain and pepsin) were found to contain histidine, and therefore the results of the tests on these two substances could not be taken as demonstrating mutagenicity. The other two substances causing increases in revertant counts (hydrogen peroxide and potassium nitrite) were mutagenic. The results on one chemical, beta-carotene, were evaluated as inconclusive or questionable. The remaining 44 substances were nonmutagenic in the test systems used. It is concluded that, for those generally physiologically innocuous chemicals tested, there are very few 'false positives' in the bacterial test systems used.

Abstract  The 96 h EL values could not be accurately determined due to large variations in cell concentrations. The EC50 values determined are reliant on confounding factors due to the concentrations used (exceedinly higher than the limit of solubility) and therefore should be treated with caution. The water solubility of octadecanol is 0.0011 mg/L at 25oC [SIDS dossier on 1-octadecanol, 1993b; Budavari, 1996]. The results indicate that no toxic effects were present at the limit of solubility of the test substance, i.e. EL50 and NOEC >0.0011 mg/L (>LoS).

Abstract  We report an atopic dermatitis patient with recurrent hand dermatitis who developed a severe allergic contact dermatitis from the use of Elidel cream. Diagnostic patch tests showed an isolated contact allergy to the emulsifier oleyl alcohol present in the product. Pimecrolimus appeared to have had an aggravating effect on the dermatitis in spite of its immunosuppressive effects. The initial clinical appearance of the patient's widespread dermatitis was atypical with resemblance to subacute cutaneous lupus erythematosus. Even though emulsifiers are widely used in topical products, contact allergic reactions to these are relatively uncommon.

Abstract  Alcohol ethoxylates (AEs) are an important group of nonionic surfactants. Commercial AEs consist of a mixture of several homologues of varying carbon chain length (Cx) and degree of ethoxylation (EOy). The major disposal route of AE is down the drain to municipal wastewater treatment plants that discharge into receiving surface waters. Sorption of AE homologues onto activated sludge and river water solids is an important factor in assessing exposure of AE in the environment. This study presents the experimental determination of sorption coefficients for a wide array of AE homologues including five alcohols under environmentally relevant conditions and combines these data with literature data to generate a predictive model for the sorption of AEs in the environment. These results demonstrate that sorption can be effectively modeled using a log Kd vs. Cx and EOy predictive equation having the form log Kd = 0.331C - 0.00897EO - 1.126(R2 = 0.64).

Abstract  To better understand the mode of action of Tadenan, a drug used in the treatment of benign prostatic hyperplasia, the effect of its active principle docosanol, IK.2, was investigated in rats. IK.2 had no effects on the weight and histologic appearance of the prostate in intact rats but increased the RNA/DNA quotient in the ventral prostate. The plasma concentrations of luteinizing hormone and testosterone were reduced. In orchiectomized animals IK.2 increased the weight of the prostate and the adrenals. In adrenalectomized, orchiectomized animals IK.2 did not increase prostatic weight but on the contrary caused a further weight reduction. IK.2 had a thymolytic effect in intact rats but not in adrenalectomized rats in which the thymus weight was increased. The results indicate that IK.2 increases adrenal steroid secretion. The supposedly higher concentration of adrenal androgens causes a stimulation of the prostate most easily discernible in orchiectomized animals. The further weight reduction of the ventral prostate in orchiectomized, adrenalectomized animals, and the increased thymus weight in adrenalectomized animals after IK.2 administration may suggest that IK.2 has effects other than the stimulatory effect on the adrenals.

Abstract  Stearyl and cetyl alcohols are the least irritating of the alcohols, and are present in many topical medicaments as vehicle ingredients. The commercial stearyl and cetyl alcohols used are not pure, but contain impurities, including other alcohols that may be potent sensitizers. We report here a case of contact dermititis due to impurities in stearyl and cetyl alcohols.

Abstract  The Polypropylene Glycol (PPG) Stearyl Ethers are polypropylene ethers of stearyl ether that function as skin-conditioning agent in cosmetic formulations. Few data on the PPG Stearyl Ethers were available. Data on chemically related PPG Butyl Ethers were reviewed as a further basis for the assessment of safety. The amounts of PPG Butyl Ethers absorbed from the digestive tract were inversely proportional to the molecular weights on the compounds; skin penetration was slow to nil. During metabolism, the butyl group was removed and oxidized, and the chains were fragmented, oxidized to weak acids, and eliminated in the urine. Little acute oral toxicity was seen in animal studies. In general, the PPG Butyl Ethers were very toxic by the intravenous route and were slightly toxic to nontoxic by the intraperitoneal and subcutaneous routes. The smaller molecular weight ethers were generally more toxic than the larger molecular weight ethers. PPG-2 Butyl Ether vapor was nontoxic by the inhalation route. Undiluted PPG-15 Stearyl Ether was practically nonirritating to the eyes of rabbits, and PPG Butyl Ethers had minor to moderate conjunctival irritation, opacity, and iritis. PPG-15 Stearyl Ether was slightly irritating to rabbit skin. PPG-2 Butyl Ether caused minor, transient erythema and desquamation during a 4-hour occlusive patch test. PPG-2 Butyl Ether did not irritate the skin of pregnant mice, was nontoxic to dams, and was not teratogenic. PPG-9-13 Butyl Ether was noncarcinogenic when fed to rats. PPG-40 Butyl Ether was nonsensitizing in clinical tests. These data were considered by the Cosmetic Ingredient Review Expert Panel to support the safety of PPG Stearyl Ethers at their current use concentrations (2% to 10%, but not greater than 25%). Data on the component ingredients, Propylene Glycol, PPG, and Steraryl Alcohol, from previous cosmetic ingredient safety assessments were also considered and found to support the safety of PPG Stearyl Ethers.

Abstract  BACKGROUND: Although many allergens in metalworking fluids (MWF) are identified, there are still some MWF components, which are not sufficiently investigated concerning their sensitizing properties.

OBJECTIVES: To investigate sensitization to 10 frequently used MWF components, which are not part of the established MWF test series, in metalworkers with suspected occupational dermatitis due to MWF.

PATIENTS/METHODS: Oleyl alcohol, myristyl alcohol, dimethylolurea, 4,4'-methylenebis morpholine, imazalil, 1-amino-2-propanol (monoisopropanolamine; MIPA), 2-amino-2-ethyl-1,3-propanediol (AEPD), 2,5-bis(n-octyldithio)-1,3,4-thiadiazole, zinc alkyl dithiophosphate and dibenzyl disulfide have been patch tested in 144 patients.

RESULTS: 7 patients reacted positively to the formaldehyde releaser 4,4'-methylenebis morpholine, and 6 of these patients also reacted to formaldehyde and/or other formaldehyde releasers. 4 patients reacted positively to myristyl alcohol tested at 10% petrolatum (pet.). Additionally, 20 doubtful or irritant reactions occurred. 1 patient each reacted positively to oleyl alcohol, MIPA, and AEPD. None of the other test substances mentioned above elicited any clear-cut positive reaction. Patch testing with well-known MWF allergens showed proportions of positive reactions, which were comparable to those from other studies, e.g. 11% to monoethanolamine, 8% to colophonium and 3%-5% to various preservatives.

CONCLUSIONS: 4,4'-methylenebis morpholine may be an important MWF allergen, although clinical relevance could not be stated definitely in every case. Myristyl alcohol should not be patch tested at 10% pet., but at a lesser concentration, due to irritant properties.

Abstract  Eighteen potential penetration enhancers, some at concentrations that might be used for that purpose, have been examined to evaluate their irritancy potential on nude mouse skin. A biopsy technique was employed followed by histological examination. Up to 50% glycerol, 10% hydroxyethyl lactamide (HELA), 10% oleyl alcohol, 10% Solketal, 10% glycofurol, 100% tetrahydrofurfuryl alcohol (THFA) and 10% urea induced no discernible change in the histological appearance of the skin whereas 100% dimethyl sulphoxide (DMSO), 100% dimethyl formamide (DMF), 100% N-methyl-2-pyrrolidone, 10% Azone, 10% oleic acid, 10% methyl laurate, 10% benzyl alcohol and 10% glycerol formal caused severe skin irritation.

Abstract  Repeat applications of an artificial monolayer to the interfacial boundary layer of large agricultural water storages during periods of high evaporative demand remains the most commercially feasible water conservation strategy. However, the interfacial boundary layer (or microlayer) is ecologically distinct from subsurface water, and repeat monolayer applications may adversely affect microlayer processes. In this study, the natural cleansing mechanisms operating within the microlayer were investigated to compare the biodegradability of two fatty alcohol (C16OH and C18OH) and one glycol ether (C18E1) monolayer compound. The C16OH and C18OH compounds were more susceptible to microbial degradation, but the C18E1 compound was most susceptible to indirect photodegradation. On clean water the surface pressure and evaporation reduction achieved with a compressed C18E1 monolayer was superior to the C18OH monolayer, but on brown water the surface pressure dropped rapidly. These results suggest artificial monolayers are readily degraded by the synergy between photo and microbial degradation. The residence time of C18OH and C18E1 monolayers on clear water is sufficient for cost-effective water conservation. However, the susceptibility of C18E1 to photodegradation indicates the application of this monolayer to brown water may not be cost-effective.

Abstract  A 65-year-old non-atopic man presented in 1 July 2012 to the emergency department of our hospital with a well-demarcated severe oedematous and vesicular reaction on the back of his right hand, extending to his wrist and forearm (Fig. 1); on the back of his left hand, he showed only a very discrete papulovesicular itching reaction. Three days previously, he had cleaned his garden shed with ammonia diluted in water by use of a sponge, thereby wearing a rubber glove on his right hand only (Vileda Comfort and Care, Comfort plus, extra-absorbent®; Vileda, Verviers, Belgium), the interior side being coated with a moisturizer, said to contain perfume and chamomile. With the left (ungloved) hand, he had occasionally held the wet sponge. He had noticed that some of the ammonia solution had spilled into the glove, but he had continued cleaning for ∼2 hr without taking it off, without any discomfort. It was only on the next day that the itching, redness and swelling started to develop. The lesions had become really severe, despite using a corticosteroid cream (Fucicort®; Leo, Wilrijk, Belgium). At the emergency unit, the patient received treatment with oral steroids, application of a wet dressing for 15 min twice daily, Diprosone® cream (Schering-Plough, Heist-op-den-Berg, Belgium), and systemic antihistamines and ibuprofen; this was followed by gradual improvement of the skin lesions after 2 weeks; the treatment was further reduced, and a moisturizer was prescribed. However, the patient was seen by us in October, and mentioned that he had stopped using the moisturizer, as it had again produced worsening of his skin lesions. The patient had been patch tested in 2009, and had been shown to be allergic to cetrimide, (a quaternary ammonium compound), isopropanol, iodine, and povidone iodine, which had been considered to be relevant to skin lesions that he had developed during wound treatment of his left elbow following osteosynthesis. The dermatitis had been treated with Fucicort® cream. Later on, he had experienced a skin reaction on his knee following the application of an ointment, the name of which he could not recall. As a retired endive farmer, he had been wearing rubber gloves for > 20 years without any skin problems.

Abstract  The role of oleic acid in the modulation of gap junction permeability was studied in cultured rat astrocytes by the scrape-loading/Lucifer yellow transfer technique. Incubation with oleic acid caused a dose-dependent inhibition of gap junction permeability by 79.5% at 50 mu M, and no further inhibition was observed by increasing the oleic acid concentration to 100 mu M. The oleic acid-mediated inhibition of gap junction permeability was reversible and was prevented by bovine serum albumin. The potency of oleic acid-related compounds in inhibiting gap junction permeability was arachidonic acid > oleic acid > oleyl alcohol > palmitoleic acid > stearic acid > octanol > caprylic acid > palmitic acid > methyloleyl ester. Oleic acid and arachidonic acid, but not methyloleyl ester, increased glucose uptake by astrocytes. Neither-oleic acid nor arachidonic acid increased glucose uptake in the poorly coupled glioma C6 cells. These results support that the inhibition of gap junction permeability is associated with the increase in glucose uptake. We suggest that oleic acid may be a physiological mediator of the transduction pathway leading to the inhibition of intercellular communication.

Abstract  The Oleth family of ingredients are the polyethylene glycol (PEG) ethers of oleyl alcohol. They are manufactured by the ethoxylation of oleyl alcohol with the number of moles of ethylene oxide corresponding to the average polyethylene glycol chain length desired. Not all of the polymer chain lengths covered in this assessment are currently reported to be used, but all are listed as cosmetic ingredients and may have been used in the past and could be used in the future. Oleths are surfactants used as emulsifying, cleansing, and solubilizing agents in cosmetic formulations. Limited safety test data are available on ingredients in the Oleth family, all consistent with surfactant properties. In feeding studies, Oleth-20 was associated with reduced body weight gain. Hepatic lesions in one exposure group were not found in any other exposure group, but were found in the controls. Oleth-20 and Oleth-10 were found to have moderate ocular irritation potential, and Oleth-10 was considered to be a cumulative skin irritant. Toxicity data, including reproductive and developmental toxicity, carcinogenesis data, and clinical testing data, available from previous safety assessments on Polyethylene Glycol and Oleyl Alcohol, were summarized. The principal finding related to PEGs, based on clinical data in burn patients, is that PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should adjust product formulations containing Polyethylene Glycol to minimize any untoward effects when products are used on damaged skin. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of Oleths in cosmetic formulations. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. Based on particle size and cosmetic use considerations, it was not considered that these ingredients, in formulation, are respirable. Based in part on the limited data available on Oleths included in the report and on the previous reviews of Polyethylene Glycol and Oleyl Alcohol, it was concluded that Oleth-2, -3, -4, -5, -6,-7,-8,-9,-10,-11,-12,-15,-16,-20,-23, -25, -30, -40, -44, and, -50 are safe in the present practices of use.

Abstract  Effectiveness of certain long carbon chain aliphatic alcohols as ovicides and larvicides was investigated under laboratory conditions against eggs and larvae of Aedes aegypti and Aedes scutellaris. Out of the eight alcohols tested, three (1-decanol, 1-undecanol and 1-dodecanol) proved to be very effective. The hatching of mosquito eggs was inhibited at a dosage of 5 to 7 litres/hectare. First, third and fourth instar larvae were killed at a dosage of 3 to 7 litres/hectare. First instar larvae were more sensitive to the alcohols than the older larvae. The shorter carbon chain alcohols (2-mercapto-ethanol, 1-butanol, benzyl alcohol and 2-octanol) proved unsatisfactory due to their volatility and solubility. Longer carbon chain alcohols (1-tetradecanol, 1-hexadecanol and 1-octadecanol), Which are solid and wax-like at room temperature, proved unsatisfactory when dissolved in hexane and applied to eggs and larvae.

Abstract  A 96 h LC50 value of >0.4 mg/L was determined for the effect of the test substance on mortality of the fish O. mykiss. The water solubility of octadecanol is 0.0011 mg/L at 25oC [SIDS dossier on 1-octadecanol, 1993b; Budavari, 1996], therefore the LC50 value is >0.0011 mg/L, The water solubility of octadecanol is 0.0011 mg/L at 25oC [SIDS dossier on 1-octadecanol, 1993b; Budavari, 1996], therefore the LC50 value is >0.0011 mg/L (>LoS), i.e. the test substance was not toxic at the LoS.