{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,3,12]],"date-time":"2025-03-12T04:24:46Z","timestamp":1741753486450,"version":"3.38.0"},"reference-count":24,"publisher":"SAGE Publications","issue":"3_suppl","license":[{"start":{"date-parts":[[2001,1,1]],"date-time":"2001-01-01T00:00:00Z","timestamp":978307200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int J Toxicol"],"published-print":{"date-parts":[[2001,1]]},"abstract":"<jats:p> Octyldodecyl Stearoyl Stearate functions as an occlusive skin-conditioning agent and as a nonaqueous viscosity-increasing agent in many cosmetic formulations. Current concentrations of use are between 0.7% and 23%, although historically higher concentrations were used. The chemical is formed by a high-temperature, acid-catalyzed esterification reaction of long-chain alcohols (primarily C-20) and a mixture of primarily C-18 fatty acids. Levels of stearic acid, octyldodecanol, and octylydocecyl hydroxystearate in the final product are 5% or less\u2014no other residual compounds are reported. Only limited safety test data were available on Octyldodecyl Stearoyl Stearate, but previous safety assessments of long-chain alcohols and fatty acids found these precursors to be safe for use in cosmetic formulations. Octyldodecyl Stearoyl Stearate produced no adverse effects in acute exposures in rats. The chemical was mostly nonirritating to animal skin at concentrations ranging from 7.5% to 10%; one study did find moderate irritation in rabbit skin at a concentration of 7.5%. Clinical tests at a concentration of 10.4% confirmed the absence of significant irritation in humans. An ocular toxicity study in rabbits found no toxicity. No evidence of genotoxicity was found in either a mammalian test system or in the Ames test system, with or without metabolic activation. The available data on Octyldodecyl Stearoyl Stearate and the previously considered data on long-chain alcohols and fatty acids, however, did not provide a sufficient basis to make a determination of safety. Additional data needs include (1) chemical properties, including the octanol\/water partition coefficient; and (2) if there is significant dermal absorption or if significant quantities of the ingredient may contact mucous membranes or be ingested, then reproductive and developmental toxicity data may be needed. Until such time as these data are received, the available data do not support the safety of Octyldodecyl Stearoyl Stearate as used in cosmetic formulations. <\/jats:p>","DOI":"10.1080\/10915810152630738","type":"journal-article","created":{"date-parts":[[2002,11,7]],"date-time":"2002-11-07T01:28:31Z","timestamp":1036632511000},"page":"51-59","source":"Crossref","is-referenced-by-count":1,"title":["Final Report on the Safety Assessment of Octyldodecyl Stearoyl Stearate"],"prefix":"10.1177","volume":"20","member":"179","published-online":{"date-parts":[[2001,1,1]]},"reference":[{"key":"atypb1","unstructured":"Alzo, Inc.1998. Technical bulletin. Unpublished data submitted by CTFA, 11\u201323\u201398. (5 pages.)2"},{"key":"atypb2","unstructured":"Consumer Product Testing.1978. Primary dermal and ocular irritation (rabbits): Octyldodecyl Stearoyl Stearate. Unpublished data submitted by CTFA, 9\u20133\u201398. (11 pages.)2"},{"key":"atypb3","unstructured":"Cosmetic, Toiletry, and Fragrance Association (CTFA).1998a. Concentration of use. Unpublished data submitted by CTFA, 1\u201321\u201398. (2 pages.)2"},{"key":"atypb4","unstructured":"CTFA.1998b. Ocular irritation, primary and cumulative skin irritation, sensitization, and clinical in-use data. Unpublished data submitted by CTFA, 6\u201326\u201398. (27 pages.)2"},{"key":"atypb5","unstructured":"CTFA.1998c. Concentration of use data on Octyldodecyl Stearoyl Stearate. Unpublished data submitted by CTFA, 11\u201318\u201398. (1 page.)2"},{"key":"atypb6","unstructured":"CTFA.1999. Concentration of use data on Octyldodecyl Stearoyl Stearate. Unpublished data submitted by CTFA, 2\/10\/99. (2 pages.)2"},{"key":"atypb7","doi-asserted-by":"publisher","DOI":"10.3109\/10915818509078685"},{"key":"atypb8","doi-asserted-by":"publisher","DOI":"10.3109\/10915818509078688"},{"key":"atypb9","doi-asserted-by":"publisher","DOI":"10.3109\/10915818709098563"},{"volume-title":"FDA database","year":"1984","key":"atypb10"},{"volume-title":"FDA database","year":"1998","key":"atypb11"},{"key":"atypb12","unstructured":"Food and Drug Research Labs, Inc.1983. Acute oral toxicity study in rats: Octyldodecyl Stearoyl Stearate. Unpublished data submitted by CTFA, 9\u20133\u201398. (12 pages.)2"},{"key":"atypb13","unstructured":"Hill Top Research, Inc.1983a. Report of a human skin test of cumulative irritation. Unpublished data submitted by CTFA, 6\u201326\u201398. (10 pages.)2"},{"key":"atypb14","unstructured":"Hill Top Research, Inc.1983b. Repeated insult patch test. Unpublished data submitted by CTFA, 6\u201326\u201398. (13 pages.)2"},{"volume-title":"Pharmaceutical and Medical Safety Bureau Notification No. 990. Partial amendments to the enforcement regulations of the Pharmaceutical Affairs Law pertaining to the relaxation of regulations for cosmetics","year":"2000","key":"atypb15"},{"key":"atypb16","unstructured":"International Specialty Products.1998. MSDS. Unpublished data submitted to CTFA, 11\u201323\u201398. (3 pages.)2"},{"key":"atypb17","unstructured":"ISP Van Dyke, Inc.1997. Technical Information Sheet for Ceraphyl 847. Unpublished data submitted to CTFA, 9\u20133\u201398. (1 page.)2"},{"key":"atypb18","unstructured":"Ivy Laboratories (KGL Inc.).1991. Final report on the determination of the contact-sensitizing potential of concealer (07C) 97750\u201301 containing 5.0% octyldodecyl stearoyl stearate (RI1095) by means of the maximization test. Unpublished data submitted by CTFA, 6\u201326\u201398. (12 pages.)2"},{"key":"atypb19","unstructured":"Santucci, L. G., ed. 1999. List of Japanese cosmetic ingredients, 4th ed. 83. Washington, DC: CTFA."},{"key":"atypb20","unstructured":"Sitek Research Laboratories.1994a. In Vivo test for chemical induction of micronucleated polychromatic erythrocytes in mouse bone marrow cells. Unpublished data submitted by CTFA, 11\u201330\u201398. (52 pages.)2"},{"key":"atypb21","unstructured":"Sitek Research Laboratories.1994b. Evaluation of a test article in the Salmonella typhimurium plate incorporation mutation assay in the presence and absence of Aroclor-induced rat liver S-9 with a confirmatory study. Unpublished data submitted by CTFA, 11\u201330\u201398. (54 pages.)2"},{"key":"atypb22","unstructured":"Trivent Chemical Company, Inc.1998. Technical bulletin. Unpublished data submitted by CTFA, 11\u201323\u201398. (5 pages.)2"},{"key":"atypb23","unstructured":"Wells Laboratories, Inc. 1993. Unpublished data submitted by CTFA, 11\u201323\u201398. (4 pages.)2"},{"key":"atypb24","unstructured":"Wenninger, J. A., R. C. Canterbery, and G. N. McEwen, Jr., eds. 2000. International Cosmetic ingredient Dictionary and Handbook, 8th ed. 921. Washington, DC: CTFA."}],"container-title":["International Journal of Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1080\/10915810152630738","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1080\/10915810152630738","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T07:20:03Z","timestamp":1741677603000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1080\/10915810152630738"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2001,1]]},"references-count":24,"journal-issue":{"issue":"3_suppl","published-print":{"date-parts":[[2001,1]]}},"alternative-id":["10.1080\/10915810152630738"],"URL":"https:\/\/doi.org\/10.1080\/10915810152630738","relation":{},"ISSN":["1091-5818","1092-874X"],"issn-type":[{"type":"print","value":"1091-5818"},{"type":"electronic","value":"1092-874X"}],"subject":[],"published":{"date-parts":[[2001,1]]}}}