{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T01:53:27Z","timestamp":1790301207819,"version":"4.1.0"},"reference-count":103,"publisher":"SAGE Publications","issue":"2_suppl","license":[{"start":{"date-parts":[[2005,3,1]],"date-time":"2005-03-01T00:00:00Z","timestamp":1109635200000},"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":[[2005,3]]},"abstract":"<jats:p>Polyacrylamide is a polymer of controllable molecular weight formed by the polymerization of acrylamide monomers available in one of three forms: solid (powder or micro beads), aqueous solution, or inverse emulsions (in water droplets coated with surfactant and suspended in mineral oil). Residual acrylamide monomer is likely an impurity in most Polyacrylamide preparations, ranging from &lt;1 ppm to 600 ppm. Higher levels of acrylamide monomers are present in the solid form compared to the other two forms. Polyacrylamide is reportedly used in 110 cosmetic formulations, at concentrations ranging from 0.05% to 2.8%. Residual levels of acrylamide in Poly acrylamide can range from &lt; .01 % to 0.1 %, although representative levels were reported at 0.02% to 0.03%. Because of the large sizes of Polyacrylamide polymers, they do not penetrate the skin. Polyacrylamide itself is not significantly toxic. For example, an acute oral toxicity study of Polyacrylamide in rats reported that a single maximum oral dose of 4.0 g\/kg body weight was tolerated. In subchronic oral toxicity studies, rats and dogs treated with Polyacrylamide at doses up to 464 mg\/kg body weight showed no signs of toxicity. Several 2-year chronic oral toxicity studies in rats and dogs fed diets containing up to 5% Polyacrylamide had no significant adverse effects. Polyacrylamide was not an ocular irritant in animal tests. No compound-related lesions were noted in a three-generation reproductive study in which rats were fed 500 or 2000 ppm Polyacrylamide in their diet. Polyacrylamide was not carcinogenic in several chronic animal studies. Human cutaneous tolerance tests performed to evaluate the irritation of 5% (w\/w) Polyacrylamide indicated that the compound was well tolerated. Acrylamide monomer residues do penetrate the skin. Acrylamide tested in a two-generation reproductive study at concentrations up to 5 mg\/kg day x in drinking water, was associated with prenatal lethality at the highest dose, with evidence of parental toxicity. The no adverse effects level was close to the 0.5 mg\/kg day x dose. Acrylamide tested in a National Toxicology Program (NTP) reproductive and neurotoxicity study at 3, 10, and 30 ppm produced no developmental or female reproductive toxicity. However, impaired fertility in males was observed, as well as minimal neurotoxic effects. Acrylamide neurotoxicity occurs in both the central and peripheral nervous systems, likely through microtubule disruption, which has been suggested as a possible mechanism for genotoxic effects of acrylamide in mammalian systems. Acrylamide was genotoxic in mammalian in vitro and in vivo assays. Acrylamide was a tumor initiator, but not an initiator\/promoter, in two different mouse strains at a total dose of 300 mg\/kg (6 doses over 2 weeks) resulting in increased lung adenomas and carcinomas without promotion. Acrylamide was tested in two chronic bioassays using rats. In one study, increased incidence of mammary gland tumors, glial cell tumors, thyroid gland follicular tumors, oral tissue tumors, uterine tumors and clitoral gland tumors were noted in female rats. In male rats, the number of tumors in the central nervous system (CNS), thyroid gland, and scrotum were increased with acrylamide exposure. In the second study, using higher doses and a larger number of female rats, glial cell tumors were not increased, nor was there an increase in mammary gland, oral tissue, clitoral gland, or uterine tumors. Tumors of the scrotum in male rats were confirmed, as were the thyroid gland follicular tumors in males and females. Taken together, there was a dose-dependent, but not statistically significant, increase in the number of astrocytomas. Different human lifetime cancer risk predictions have resulted, varying over three orders of magnitude from 2 \u00d7 10 3 to 1.9 \u00d7 120 6. In the European Union, acrylamide has been limited to 0.1 ppm for leave-on cosmetic products and 0.5 ppm for other cosmetic products. An Australian risk assessment suggested negligable health risks from acrylamide in cosmetics. The Cosmetic Ingredient Review (CIR) Expert Panel acknowledged that acrylamide is a demonstrated neurotoxin in humans and a carcinogen in animal tests, but that neurotoxic levels could not be attained by use of cosmetics. Although there are mechanisms of action of acrylamide that have been proposed for tumor types seen in rat studies that suggest they may be unique to the rat, the Panel was not convinced that these results could be disregarded as a species-specific finding with no relevance to human health and safety. Based on the genotoxicity and carcinogenicity data, the Panel does not believe that acrylamide is a genotoxic carcinogen in the usual manner and that several of the risk assessment approaches have overestimated the human cancer risk. The Panel did conclude, however, that it was appropriate to limit acrylamide levels to 5 ppm in cosmetic formulations.<\/jats:p>","DOI":"10.1080\/10915810590953842","type":"journal-article","created":{"date-parts":[[2005,9,19]],"date-time":"2005-09-19T13:47:41Z","timestamp":1127137661000},"page":"21-50","source":"Crossref","is-referenced-by-count":88,"title":["Amended Final Report on the Safety Assessment of Polyacrylamide and Acrylamide Residues in Cosmetics1"],"prefix":"10.1177","volume":"24","member":"179","published-online":{"date-parts":[[2005,3,1]]},"reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1110(88)90015-2"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1218(88)90124-3"},{"key":"atypb3","unstructured":"American Cyanamid Company. 1960a. Report on Accostrength Resin 2386: two-year feeding to rats. Submitted by FDA in response to an FOI request."},{"key":"atypb4","unstructured":"American Cyanamid Company. 1960b. Report on Accostrength Resin 2386: two-year feeding to dogs. Submitted by FDA in response to an FOI request."},{"key":"atypb5","unstructured":"Arany, J. 1985. Acrylamide monomer Salmonella\/microsome test (SMT). NTIS Report OTS-0000440-0."},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.1006\/taap.1993.1085"},{"key":"atypb7","doi-asserted-by":"publisher","DOI":"10.1016\/S0015-0282(16)44547-4"},{"key":"atypb8","first-page":"107","volume":"44","year":"1984","journal-title":"Cancer Res."},{"key":"atypb9","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3835(84)90138-1"},{"key":"atypb10","doi-asserted-by":"publisher","DOI":"10.1139\/o73-215"},{"key":"atypb11","doi-asserted-by":"publisher","DOI":"10.1006\/taap.1994.1127"},{"key":"atypb12","doi-asserted-by":"publisher","DOI":"10.1016\/0041-008X(85)90352-7"},{"key":"atypb13","first-page":"386","volume":"16","year":"1972","journal-title":"Acta Cytol."},{"key":"atypb14","doi-asserted-by":"publisher","DOI":"10.1006\/faat.1995.1104"},{"key":"atypb15","first-page":"616","volume":"14","year":"1969","journal-title":"Toxicol. Appl. Pharmacol."},{"key":"atypb16","doi-asserted-by":"publisher","DOI":"10.1016\/0165-7992(88)90117-0"},{"key":"atypb17","unstructured":"COLIPA. 1999. Quantification of cancer risk due to dermal exposure to acrylamide as a result of cosmetic application. Unpublished data submitted by the European Cosmetic Toiletry and Perfumary Association (COLIPA) to the European Commission. 15 pages."},{"key":"atypb18","unstructured":"Cosmetic, Toiletry, and Fragrance Association (CTFA). 1990. Residual acrylamide monomer content of polyacrylamide. Unpublished data submitted by CTFA."},{"key":"atypb19","unstructured":"CTFA. 2000. Evaluation of the toxicology of polyacrylamides for use in leave-on cosmetics with special reference to acrylamide monomer. Unpublished data submitted by CTFA, April, 2000. 18 pages."},{"key":"atypb20","doi-asserted-by":"publisher","DOI":"10.1016\/0014-5793(77)80717-5"},{"key":"atypb21","first-page":"495","volume":"12","year":"1998","journal-title":"In Vivo"},{"key":"atypb22","doi-asserted-by":"publisher","DOI":"10.1007\/BF01928732"},{"key":"atypb23","doi-asserted-by":"publisher","DOI":"10.1530\/acta.0.0700385"},{"key":"atypb24","unstructured":"Diembeck, W., H.J. D\u00fcsing, and M. Akhani. 1998. Dermal absorption and penetration of acrylamide ([C14]-acrylamide as tracer) in different cosmetic formulations and polyacrylamide-solution after topical application to excised pig skin. Unpublished data submitted by CTFA. 8 pages."},{"key":"atypb25","unstructured":"Dow. 1955. Industrial, medical, and environmental health experience of human subjects employed in the research, development, and production of Dow Polyacrylamides. Submitted by FDA in response to an FOI request."},{"key":"atypb26","unstructured":"Dow. 1957. Two-year study in rats of polymer containing 0.05-0.15% monomer. Submitted by FDA in response to an FOI request."},{"key":"atypb27","unstructured":"Dow. 1958. A Study of the fate of Polyacrylamide-C in the rat. Submitted by FDA in response to an FOI request."},{"key":"atypb28","unstructured":"Dybing, E., and T. Sanner. 1997. Risk assessment: Cosmetics containing acrylamide. unpublished data submitted by FDA, April 29, 1998. 14 pages."},{"key":"atypb29","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600700629"},{"key":"atypb30","doi-asserted-by":"publisher","DOI":"10.1016\/0165-7992(92)90106-R"},{"key":"atypb31","unstructured":"Environmental Protection Agency (EPA). 1990. Assessment of health risks from exposure to acrylamide. Washington, DC: U. S. EPA."},{"key":"atypb32","doi-asserted-by":"publisher","DOI":"10.1016\/0005-2795(73)90276-6"},{"key":"atypb33","unstructured":"European Commission. 1999. Opinion of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers concerning ACRYLAMIDE RESIDUES IN COSMETICS adopted by the plenary session of the SCCNFP of 30 September 1999. http:\/\/europa. eu. int\/comm\/food\/fs\/sc\/sccp\/out95_en. html."},{"key":"atypb34","unstructured":"Food and Drug Administration (FDA). 1989. Cosmetic ingredient concentration and frequency of use data.\n                      FDA database.\n                      Washington, DC: FDA."},{"key":"atypb35","unstructured":"FDA. 2002. Cosmetic ingredient product frequency of use data.\n                      FDA database.\n                      Washington, DC: FDA."},{"key":"atypb36","unstructured":"FDA. 2003. Acrylamide in food. Information from the FDA web site. http:\/\/www.cfsan.fda.gov\/dms\/acryplan.html and http:\/\/www.fda.gov\/fdac\/ features\/2003\/103_food. html."},{"key":"atypb37","unstructured":"Franz, S. W, M. D. Dryzga, and N. L. Freshour. 1998. In vitro\/In vivo determination of cutaneous penetration by residual acrylamide monomer from polyacrylamide water solutions. Unpublished data submitted by CTFA, 30 pages."},{"key":"atypb38","doi-asserted-by":"publisher","DOI":"10.1006\/faat.1995.1112"},{"key":"atypb39","unstructured":"Fujiki, M., J. Asada, and T. Shimizu. 1985. Studies on analytical method of acrylamide monomer and accumulation into fish.\n                      Goverment Reports, Announcements and Index.\n                      AD-P004 735, AD-P004 761."},{"key":"atypb40","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-1218(96)90106-8"},{"key":"atypb41","unstructured":"Greenberg, K.2002.Using panels to understand the consumer.Consumer Insight Magazine, http:\/\/acnielson.com\/pubs\/ci\/2002\/ql\/features\/panels. htm."},{"key":"atypb42","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-2494.1982.tb00300.x"},{"key":"atypb43","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-2494.1983.tb00350.x"},{"key":"atypb44","doi-asserted-by":"publisher","DOI":"10.1016\/0272-0590(92)90045-J"},{"key":"atypb45","unstructured":"Hawley, G. G., ed. 1971.The condensed chemical dictionary, 174. New York: Van Nostrand Reinhold."},{"key":"atypb46","unstructured":"Hendricxx, B. 1985. Mitotic recombination in\n                      Saccharomyces cerevisiae ?\n                      (MRC). NTIS Report OTS0000440-0."},{"key":"atypb47","unstructured":"Hills, B. 1985. Industrywide studies report of walkthrough survey of American Cyanamid plant, Westwego, Louisiana, project no. P-84-30. Division of Surveillance, Hazard Evaluations, and Field Studies, NIOSH, HHS. Report no. IWS-145-14. Cincinnati, Ohio: NIOSH."},{"key":"atypb48","unstructured":"Hollander, L. 1952. Preliminary patch test results in 25 persons. NTIS Report No. OTS-0206055."},{"key":"atypb49","unstructured":"International Agency for Research on Cancer. 1986. Some chemicals used in plastics and elastomers. World Health Organization, ISBN\u223c92-832-1239-8, vol. 39."},{"key":"atypb50","first-page":"35","volume":"88","year":"1973","journal-title":"Cosmet. Perfum."},{"key":"atypb51","first-page":"46","volume":"123","year":"1978","journal-title":"Drug. Cosmet. Ind."},{"key":"atypb52","doi-asserted-by":"publisher","DOI":"10.1016\/0041-008X(86)90109-2"},{"key":"atypb53","doi-asserted-by":"publisher","DOI":"10.1016\/S0091-679X(08)60482-3"},{"key":"atypb54","unstructured":"Kraeling, E. K., and R. L. Bronaugh. 2001. Percutaneous absorption of acrylamide in fuzzy rat and human skin-preliminary report. Unpublished data submitted by FDA. 8 pages."},{"key":"atypb55","doi-asserted-by":"publisher","DOI":"10.1016\/S1383-5718(96)00122-2"},{"key":"atypb56","first-page":"173","volume":"1","year":"1975","journal-title":"Lancet"},{"key":"atypb57","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1098-2280(1997)30:4<410::AID-EM6>3.0.CO;2-M"},{"key":"atypb58","doi-asserted-by":"publisher","DOI":"10.1136\/oem.56.3.181"},{"key":"atypb59","unstructured":"Marty, J.P, and C.M. Vincent. 1998. In vitro percutaneous absorption of acrylamide across human skin. Unpublished data submitted by CTFA. 63 pages."},{"key":"atypb60","doi-asserted-by":"publisher","DOI":"10.1016\/0041-008X(65)90119-5"},{"key":"atypb61","unstructured":"Ministry of Health, Labor, and Welfare (MHLW). 2000. Pharmaceutical and Medical Safety Bureau Notification No. 990. Ministry of Health, Labor and Welfare, Pharmaceutical and Medical Safety Bureau, Inspection and Guidance Divison, 2-2, 1-chrome, Kasumigaseki, Chiyoda-ku, Tokyo 100-8045, Japan."},{"key":"atypb62","first-page":"46","volume":"123","year":"1984","journal-title":"Drug Cosmet. Ind."},{"key":"atypb63","doi-asserted-by":"publisher","DOI":"10.1016\/0378-4274(81)90032-1"},{"key":"atypb64","doi-asserted-by":"publisher","DOI":"10.1159\/000459420"},{"key":"atypb65","unstructured":"National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Australia. 2002.\n                      Acrylamide. Priority Existing Chemical Assessment Report No. 23.\n                      Commonwealth of Australia: Sydney, NSW"},{"key":"atypb66","doi-asserted-by":"publisher","DOI":"10.1016\/0019-2791(72)90078-X"},{"key":"atypb67","volume-title":"International cosmetic ingredient dictionary and handbook.","year":"2002"},{"key":"atypb68","unstructured":"Pharmakon Research International, Inc. 1982a. Ames\n                      Salmonella\/microsome\n                      plate test. PH 301D-AC-004-82. Acrylamide monomer and acrylonitrile. NTIS Report No. OTS0206055."},{"key":"atypb69","unstructured":"Pharmakon Research International, Inc. 1982b. CHO\/HGPRT mammalian cell forward gene mutation assay with and without metabolic activation. PH 314-AC-001-82. Acrylamide. NTIS Report No. OTS0206055."},{"key":"atypb70","unstructured":"Pharmakon Research International, Inc. 1982c. Rat hepatocyte primary culture\/DNA repair test. PH 311-AC-001-82. Acrylamide. NTIS Report No. OTS0206055."},{"key":"atypb71","unstructured":"Ramsey, J. C, J. D. Young, and S. J. Gorzinski. 1984. Acrylamide: Toxicodynamics in rats. Unpublished data submitted by CTFA. 14 pages."},{"key":"atypb72","first-page":"1","volume":"31","year":"1975","journal-title":"ACS. Symp. Ser."},{"key":"atypb73","doi-asserted-by":"publisher","DOI":"10.1016\/0165-7992(91)90114-J"},{"key":"atypb74","doi-asserted-by":"publisher","DOI":"10.1016\/0027-5107(94)90101-5"},{"key":"atypb75","doi-asserted-by":"publisher","DOI":"10.1016\/0378-5173(86)90160-2"},{"key":"atypb76","unstructured":"Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP). 1999. Opinion on acrylamide residues in cosmetics adopted by the plenary session of the SCCNFP of 30, September 1999. http:\/\/europa.eu.int\/comm\/food\/fs\/sc\/sccp\/out95_en.html"},{"key":"atypb77","unstructured":"Scientific Committee on Food (SCF). Opinion of the SCF on new findings regarding the presence of acrylamide in food expressed on 3 July, 2002. http:\/\/europa.eu.int\/comm\/food\/fs\/sc\/scf\/outl31 _en.html"},{"key":"atypb78","unstructured":"Scientific Committee on Toxicity, Exotoxicity, and the Environment (CSTEE). Opinion on the results of the risk assessment of: Acrylamide. Opinion expressed at the 22nd CSTEE plenary meeting, 6\/7 March, 2001. http:\/\/europa.eu.int\/comm\/food\/fs\/sc\/sct\/outcome_en.html"},{"key":"atypb79","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1218(90)90101-7"},{"key":"atypb80","doi-asserted-by":"publisher","DOI":"10.1002\/em.2850160302"},{"key":"atypb81","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1161(89)90008-3"},{"key":"atypb82","doi-asserted-by":"publisher","DOI":"10.1002\/em.2860090403"},{"key":"atypb83","unstructured":"Shipp, A. M., G. A. Lawrence, C. B. Van Landingham, and P. R. Gentry. 2001a. Hazard identification and dose-response analysis for acrylamide. Unpublished data submitted by CTFA. 164 pages."},{"key":"atypb84","unstructured":"Shipp, A. M., G. A. Lawrence, and C. B. Van Landingham. 2001b. Estimates of acrylamide intake from the use of personal care products containing poly-acrylamide: A monte carlo analysis. Unpublished data submitted by CTFA. 53 pages."},{"key":"atypb85","doi-asserted-by":"publisher","DOI":"10.1080\/15287399509531944"},{"key":"atypb86","unstructured":"Silvestro, E., and M. Crocker.1981.Toxicity of chemical compounds used for enhanced oil recovery. Final Report.Government Reports, Announcements, and Index8:2(5-6), 3(1-4)."},{"key":"atypb87","first-page":"215","volume":"9","year":"1991","journal-title":"Rev. Environ. Health"},{"key":"atypb88","unstructured":"SNF. 2001a. Use of acrylamide-based polymers in the cosmetics industry. Unpublished data provided by CTFA. 5 pages."},{"key":"atypb89","unstructured":"SNF. 2001b. Industry recommendations. Unpublished data submitted by SNF. 1 page"},{"key":"atypb90","unstructured":"Sumner, S. C. J., B. Asgharian, C. C. Williams, and T. R. Fennell. 2001. Acrylamide: Metabolism, Distribution, and hemoglobin adducts in Male F344 Rats and B6C3F1 mice following inhalation exposure and distribution and hemoglobin adduct following dermal application to F344 Rats. Unpublished data submitted by CTFA. 26 pages."},{"key":"atypb91","doi-asserted-by":"publisher","DOI":"10.1021\/tx00025a014"},{"key":"atypb92","unstructured":"Sumner, S. C. J., C. C. Williams, and T. R. Fennell. 1999. Characterization of urinary metabolites of [l,2,3-C]acrylamide in male F344 rats following dermal application or IP injection. Unpublished data submitted by CTFA. 44 pages."},{"key":"atypb93","doi-asserted-by":"publisher","DOI":"10.1021\/es60146a002"},{"key":"atypb94","doi-asserted-by":"publisher","DOI":"10.1016\/0142-9612(86)90050-5"},{"key":"atypb95","first-page":"21","volume":"259","year":"1991","journal-title":"Drosophila melanogaster. Mutat. Res."},{"key":"atypb96","doi-asserted-by":"publisher","DOI":"10.1093\/mutage\/8.1.23"},{"key":"atypb97","unstructured":"Union Carbide. 1987. Combined two-generation reproduction study and dominant lethal assay in Fischer 344 rats administered acrylamide in the drinking water. NTIS Report No. OTS0536439."},{"key":"atypb98","first-page":"245","volume":"1","year":"1977","journal-title":"Biomed Appl. Immobilized Enzyme Proteins"},{"key":"atypb99","unstructured":"Valencia, R. 1984. Drosophila sex-linked recessive assay of acrylamide. NTIS Report No. OTS-0206897."},{"key":"atypb100","unstructured":"West, R. 1959. Investigation of the fate of orally administered acrylamide in small animals using carbon-14 tagged material. NTIS Report OTS-0206055."},{"key":"atypb101","doi-asserted-by":"publisher","DOI":"10.1118\/1.595666"},{"key":"atypb102","unstructured":"World Health Organization (WHO). 1985. Acrylamide.\n                      Environm. Health Criteria\n                      49:1-121."},{"key":"atypb103","unstructured":"WHO. 1996. Guidelines for drinking water quality. Vol 2. Health criteria and other supporting information, 2nd ed. Geneva: WHO."}],"container-title":["International Journal of Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1080\/10915810590953842","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1080\/10915810590953842","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T10:22:05Z","timestamp":1777458125000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1080\/10915810590953842"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2005,3]]},"references-count":103,"journal-issue":{"issue":"2_suppl","published-print":{"date-parts":[[2005,3]]}},"alternative-id":["10.1080\/10915810590953842"],"URL":"https:\/\/doi.org\/10.1080\/10915810590953842","relation":{},"ISSN":["1091-5818","1092-874X"],"issn-type":[{"value":"1091-5818","type":"print"},{"value":"1092-874X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2005,3]]}}}