Abstract  A 28-year-old woman presented with a several year history of persistent itchy and scaly erythema on the lips, which appeared after using five different kinds of lipsticks, A–E. Because we suspected contact dermatitis to ingredients of these lipsticks, we patch tested her with the lipsticks A–E (as is) and the ingredients of lipsticks D and E provided by the manufacturers. The patient showed positive reactions to all lipsticks and oleyl alcohol (10% pet.), diisostearyl maleate (40% pet.), glyceryl isostearate (1% pet.), and Lithol Rubine BCA (Pigment Red 57, Red 202; CAS 5281-04-91) (1% pet.) (Table 1). These concentrations were the same as those in lipsticks D and E. Three normal controls showed negative reactions to these ingredients. Our patient stopped using these lipsticks, now only occasionally using lip cream free from these allergens and she is now symptom free.

Abstract  BACKGROUND: Recurrent herpes simplex labialis (HSL) occurs in 20% to 40% of the US population. Although the disease is self-limiting in persons with a healthy immune response, patients seek treatment because of the discomfort and visibility of a recurrent lesion.

OBJECTIVE: Our purpose was to determine whether docosanol 10% cream (docosanol) is efficacious compared with placebo for the topical treatment of episodes of acute HSL.

METHODS: Two identical double-blind, placebo-controlled studies were conducted at a total of 21 sites. Otherwise healthy adults, with documented histories of HSL, were randomized to receive either docosanol or polyethylene glycol placebo and initiated therapy in the prodrome or erythema stage of an episode. Treatment was administered 5 times daily until healing occurred (ie, the crust fell off spontaneously or there was no longer evidence of an active lesion) with twice-daily visits.

RESULTS: The median time to healing in the 370 docosanol-treated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo-treated patients (P =.008; 95% confidence interval [CI]: 2, 22). The docosanol group also exhibited reduced times from treatment initiation to (1) cessation of pain and all other symptoms (itching, burning, and/or tingling; P =.002; 95% CI: 3, 16.5); (2) complete healing of classic lesions (P =.023; 95% CI: 1, 24.5); and (3) cessation of the ulcer or soft crust stage of classic lesions (P <.001; 95% CI: 8, 25). Aborted episodes were experienced by 40% of the docosanol recipients versus 34% of placebo recipients (P =.109; 95% CI for odds ratio: 0.95, 1.73). Adverse experiences with docosanol were mild and similar to those with placebo.

CONCLUSION: Docosanol applied 5 times daily is safe and effective in the treatment of recurrent HSL. Differences in healing time compared favorably with those reported for the only treatment of HSL that has been approved by the Food and Drug Administration.

Abstract  Animal studies have been carried out on a series of highly branched primary aliphatic alcohols. The alcohols were amyl, hexyl, isooctyl, 2-ethylhexyl, isononyl, decyl, tri-decyl, and hexadecyl. The tests included oral and dermal LD50, eye and skin irritation, and 6-hour vapor exposure. Oral LD50 values in rats ranged from 1.5 to greater than 8.4 gm/kg and did not show a consistent increase with increased molecular weight. Signs of effect were associated with central nervous system depression. Dermal LD50 values in rabbits were all greater than 2.6 or 3.2 gm/kg, the highest dose tested, although percutaneous absorption was seen. Skim irritation was slight to severe and generally inversely related to molecular weight. The C5 through C13 alcohols produced moderate to severe eye irritation; the C16 alcohol produced only slight irritation. Inhalation toxicity was low, with systemic effects seen only with amyl, 2-ethylhexyl, and isononyl alcohols. Some eye, nose, throat, or respiratory tract irritation was seen with each alcohol.

Abstract  A young woman being treated for linear scleroderma became allergic to fluocinonide (Lidex) cream while using it with occlusion. She was able to continue treatment with fluocinonide ointment without an adverse reaction. Patch testing with the ingredients of the cream demonstrated sensitization to an impurity in commercial stearyl alcohol and irritation from propylene glycol. The woman had no adverse reactions to fluocinonide ointment because this preparation contains no stearyl alcohol and very little propylene glycol. This case reemphasizes the important role of vehicles in contact allergy and indicates that allergic sensitization may be induced despite the presence of a potent topical steroid.

Abstract  EfudixA cream or topical 5% 5-fluorouracil (5-FU) is an antimitotic cream used to treat premalignant and malignant skin lesions (1). Although it commonly causes cutaneous irritation, allergic contact dermatitis is uncommon (2). There is only 1 previous report of contact sensitivity from stearyl alcohol in EfudixA cream (3).

Abstract  SIDS INITIAL ASSESSMENT: There is need for further work. SHORT SUMMARY OF THE REASONS WHICH SUPPORT THE RECOMMENDATION: The substance is firmly bound to sediments, and therefore anaerobic biodegradation can be an important factor. A 21-day test in daphnids indicated that the substance may be toxic at a range of between 1 and 3mg/l. FURTHER WORK RECOMMENDED: Determination of anaerobic biodegradability. Depending on the results of this test, it may be considered whether or not long-term fish toxicity testing is required.

Abstract  The effects of alkyl alcohols and related chemicals on the ultrastructure of mitochondria in the rat hepatocyte were studied. The following three different groups of chemicals were tested: Group 1: alkyl alcohols with straight carbon chains (ethanol, 1-propanol, 1-butanol, 1-pentanol, 1-octanol, 1-dodecanol and 1-octadecanol); Group 2: tert- and cyclo-compounds (tert-butanol, cyclo-pentanol, and cyclo-hexanol); and Group 3: polyhydroxy alcohols (ethylene glycol, propylene glycol, 1, 3-propanediol, glycerol and pentaerythritol). Results obtained were summarized as follows: 1) Ethanol, 1-propanol, 1-butanol, 1-pentanol and 1-octanol had essentially the same effects on the mitochondrial ultrastructure: a mixed population of small and enlarged mitochondria with poorly developed cristae; 1-dodecanol induced ultrastructural changes of mitochondria of two distinct types: a mixed population of small and enlarged mitochondria with poorly developed cristae in some hepatocytes and remarkably enlarged mitochondria with well-developed cristate in others; and 1-octadecanol induced remarkably enlarged mitochondria in all hepatocytes. 2) Chemicals belonging to group 2 and group 3 induced essentially the same changes as those induced by 1-octadecanol. More than one month was required to induce those changes. The mechanism by which those ultrastructural mitochondrial changes were induced is not clear, but the present results may suggest that the hydroxy group (-OH) common to all these chemicals in some way accounts for the phenomenon.

Abstract  Oleyl alcohol is a mixture of aliphatic alcohols, consisting mainly of 9 octadecen-l-ol. It is commonly found as an emulsifier in hair applications and lipsticks, and is used in other topical preparations, as well as in textile oils and in the manufacture of paper and printing inks.

Abstract  A 46 year old male metalworker was seen with a 3 year history of eczema of both hands. The eczema cleared within several weeks of absence from work. Patch tests conducted 2 years earlier had been negative. New patch tests were done with the German Contact Dermatitis Group standard series, two preservative series and a metal and metalworking series. Positive reactions seen for p-phenylenediamine (106503), p-aminobenzene (62533), and gold-sodium-thiosulfate (10233882) were not considered clinically relevant. A repetitive open application test using cutting fluid induced eczematous lesions. Patch tests with three concentrations of the fluid were also positive.Further patch tests using the components of the cutting fluid gave positive reactions to 2-amino-ethanol (141435) and oleyl-alcohol (143282). A previous report of 2-amino-ethanol occupational contact dermatitis in metalworkers was cited. Reports of sensitization to oleyl-alcohol were also cited, but none involved cutting fluids. No cross sensitivity to ethanol (64175) was observed in this patient. The author concludes that the patient had developed occupational contact dermatitis to 2-amino-ethanol and oleyl-alcohol in the metal cutting fluid.

Abstract  Behenyl alcohol is a saturated 22-carbon, long-chain aliphatic alcohol, which has potential for use in foods as an oil-structuring and -solidifying agent in fats. Previously completed studies with behenyl alcohol indicated an absence of mutagenic or genotoxic potential. In addition, subchronic toxicity studies in rats and dogs reported no adverse effects following gross and histopathological examinations. Compound-related effects were limited to the observation of pale feces in dogs treated with high doses of behenyl alcohol, and were attributable to unabsorbed behenyl alcohol. The reproductive effects of behenyl alcohol were investigated in a fertility and reproduction study, and an embryonic development study in rats and rabbits, respectively. No evidence of maternal or fetal toxicity was observed in either study. Behenyl alcohol demonstrated no effects on the fertility or reproduction of rats dosed up to 1000 mg/kg body weight. Similarly, behenyl alcohol had no reproductive effects on rabbits treated with doses up to 2000 mg/kg body weight. The observation of pale feces was the only compound-related effect reported, limited to rabbits treated with 2000 mg behenyl alcohol/kg body weight. Based on these findings, there is no evidence to suggest that behenyl alcohol is teratogenic or embryotoxic.

Abstract  The examination of a number of potential and currently used carrier fluids for invert emulsion drilling fluids in the ECETOC screening test revealed clear differences with respect to their easy anaerobic biodegradability. Fatty acid- and alcohol-based ester oils exhibited excellent anaerobic degradation to the gaseous final end products of the methanogenic degradation pathway, methane and carbon dioxide. Mineral oils, dialkyl ethers, alpha-olefins, polyalphaolefins, linear alkylbenzenes and an acetal-derivative were not or only slowly degraded. Although the poor degradation results obtained in the stringent ECETOC screening test may not be regarded as final proof of anaerobic recalcitrance, nevertheless, these results were found to be in line with the present understanding of the structural requirements for anaerobic biodegradability of chemicals. The validity of the conclusions drawn is corroborated by published results on the anaerobic biodegradation behaviour of ester oils, mineral oils and alkylbenzenes in marine sediments.

Abstract  Both assays demonstrated a lack of mutagenic activity by behenyl alcohol. No significant and reproducible increases in the number of revertants were found in any strain and behenyl alcohol treatment group combination relative to the solvent control. In addition, no concentration-dependent enhancement of the revertant number occurred, and no differences were observed between behenyl alcohol treatments with or without metabolic activation. Strain text description: S. typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100 Criteria for Postive Results: For a test substance to be considered positive in tester strain TA100, at least a twofold increase was required in the number of reversions. In tester strains TA1535, TA1537, TA1538, and TA98, a test substance was considered positive when the number of reversions was at least three times higher than the spontaneous reversion rate. In addition, a dose-dependent increase in the number of revertants was regarded as an indication of possible mutagenic potential, regardless of whether the highest dose induced a two- to threefold increase in the number of revertants. Genotoxic Effect: Negative

Abstract  A standardized, feasible test system for assessing the environmental behavior of chemicals in ecotoxicological terms and for setting up priority lists was described earlier. 14C chemicals were used in environmentally relevant concentrations. The bioaccumulation potential of chemicals was determined from tests with algae and fish; mammalian retention and elimination were investigated in a test with rats. Information about biodegradability, metabolism, accumulation, and bound residues was provided by the activated sludge test, while the possibility of photomineralization of the organic compounds was studied by irradiation with uv light of wavelength above 290 nm. The presentation of the data is by ranking in tables: they are either ranked in order of decreasing accumulation in the algae, fish, rat, and activated sludge tests (lipophilic substances such as hexachlorobenzene, chlorinated biphenyls, aldrin, etc., displaying the highest accumulation, are on top of the lists); or they are ranked in order of increasing degradability in the activated sludge and photomineralization tests (the most persistent chemicals thus again are on the top of the list). The data obtained from the accumulation tests are correlated with respective physicochemical properties of the chemicals and the results of the tests are compared with one another for ecotoxicological profile assessment.

Abstract  A test system is described for assessing the mineralization of 14C-radiolabeled compounds to carbon dioxide (CO2) and methane (CH4) under anaerobic conditions. Environmentally realistic concentrations of test chemicals were incubated with anaerobic digester sludge in sealed vessels at 35 °C. The headspace of these vessels was continuously purged with nitrogen, which was passed through a series of potassium hydroxide (KOH) scrubbers to trap 14CO2. This effluent gas was mixed with oxygen and passed through a combustion tube containing cupric oxide at 800 °C to convert 14CH4 to 14CO2, which was subsequently trapped in a second series of KOH traps. Trapping efficiency was 97.1 ± 5% for 14CO2 and 108 ± 13% for 14CH4. The system was used to evaluate the mineralization of several organic chemicals including glucose, palmitic acid, hexadecanol, and two surfactants, alkyl ethoxylate sulfate (AES) and alkyl sulfate (AS), in anaerobic digester sludge. Total yields of 14CH4 and 14CO2 from these compounds exceeded 80%, and the total mass balances generally exceeded 95%. Mineralization of hexadecanol was described by a simple first-order production equation, while that of the other compounds was best described by a three-half-order model. This system provided excellent recovery of radioactive gases and consequently excellent mass balances. Given the reproduction of in situ condition and the realistic ratio of test material to biomass, the test system also generated relevant kinetic data. It, therefore, has application for demonstrating the significance of biodegradation as a removal mechanism during anaerobic digestion as well as determining the completeness of anaerobic biodegradation.

Abstract  The rat oral LD50 for Nacol 22 RD is >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored.

Abstract  Pure n-alkanes and 1-alkanols promoted papilloma growth in the skin of Swiss mice which had been treated with a noncarcinogenic dose of dimethylbenzanthracene. Decanol, dodecane, and tetradecane were the most potent; hexanol, hexane, and octane were inactive. One-fourth of the papillomas became squamous cell carcinomas. A difference of two carbon atoms separated equipotent alkanes and alkanols. The tumor-promoting effect of these substances was not identical with that of a croton extract studied under similar conditions.

Abstract  SIDS dossiers already existed for 1-Dodecanol (CAS 112-53-8) and 1-Octadecanol (CAS 112-92-5) (published in 1998 and 1995 respectively); the present document updates and extends the earlier ones; brings in new information, and therefore replaces it. No conclusions drawn in the earlier review are amended. Available data for these substances are compiled in SIDS dossiers related to each CAS number. The reliability of each data point has been considered during this period of review, in accordance with the guidance of the Fraunhofer Institut für Toxikologie und Aerosolforschung. The following standard reliability codes, defined by Klimisch et al. (1997)1, apply, in accordance with the SIDS guidance: (1) Valid without restriction (2) Valid with restrictions (3) Invalid (4) Not assignable. Results considered to be Invalid are not used in the discussions or conclusions in this report. However, results which are of Non-assignable reliability may be fully valid, although insufficient details were available to be sure of this; therefore reliability (4) results are used in this report. The reliability code of each data point is given. Key studies are flagged in the SIDS dossiers. These are studies with the highest reliability/adequacy. If several studies showed comparable reliability/ adequacy, the study with the lowest LC/LD/EC50 or NOEC/ NOAEL has been indicated as the key study. For some endpoints, fully reliable results are not available and it has been necessary to use a weight of evidence including results of studies of non-assignable reliability. In such cases the results are identified as key studies as they are of high importance to the data set. For transparency, some study summaries in the SIDS dossier have been transferred from the previously published version of IUCLID or from the previous SIDS submission. In some cases, it has not been possible to retrieve the original literature/study reports using the reported citation or as a result of literature searching. In some cases, change of business ownership meant that internal study reports cited in previous summaries could not be accessed. In some other cases, e.g. certain non-SIDS endpoints, and in areas where a very large amount of literature has been published, it was not considered necessary to pursue all individual published sources due to weight of evidence of more reliable results. In all cases, reliability (4) applies, because the original documentation has not been reviewed in the development of the dossier. Such results are clearly identified in the SIDS dossier and more details are given therein.