The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of synthetically manufactured amorphous Silica and Hydrated Silica. The Panel considered the method of manufacture of these ingredients to be of significant importance when reviewing safety. Thus, the current assessment is exclusive to amorphous Silica and Hydrated Silica when manufactured via synthetic methods. Both of these ingredients are reported to function as abrasives, absorbents, anticaking agents, bulking agents, and opacifying agents in cosmetic products. The Panel reviewed relevant data, including frequency and concentration of uses. The Panel concluded that synthetically manufactured amorphous Silica and Hydrated Silica are safe in the present practices of use and concentration when formulated to be non-irritating.
HepplestonA. The fibrogenic action of silica. Br Med Bull. 1969;25(3):282-287.
5.
BeckerLBergfeldWBelsitoD, et al.Safety assessment of silica and related cosmetic ingredients. Review CI, ed; 2009.
6.
The Synthetic Amorphous Silica and Silicates Industry Association. Nanoscale Materials Stewardship Program (NMSP) voluntary submittal package for synthetic amorphous silica. Washington, DC. Submitted to CIR by the Synthetic Amorphous Silica and Silicate Industry Association on March 11, 2019; 2008.
7.
ArtsJMuijserHDuistermaatEJunkerKKuperC. Five-day inhalation toxicity study of three types of synthetic amorphous silicas in Wistar rats and post-exposure evaluations for up to 3 months. Food Chem Toxicol. 2007;45(10):1856-1867.
8.
LewinsonJMayrWWagnerH. Characterization and toxicological behavior of synthetic amorphous hydrophobic silica. Regul Toxicol Pharmacol. 1994;20(1 Pt 1):37-57.
9.
National Institute for Occupational Safety and Health (NIOSH). NIOSH pocket guide to chemical hazards: silica, amorphous. https://www.cdc.gov/niosh/npg/npgd0552.html. Last Updated: 2018. Accessed: 11/1/2018.
PavlichD. Comments from the synthetic amorphous silica and silicate industry association to cosmetic ingredient review. Unpublished data submitted to CIR by the Synthetic Amorphous Silica and Silicate Industry Association on March 11, 2019; 2019.
12.
Council of Experts, United States Phamacopeial Convention. Food Chemicals Codex. 8th ed.Rockville, MD: United States Pharmacopeia (USP); 2012.
13.
ByersPGageJ. The toxicity of precipitated silica. Br J Ind Med. 1961;18(4):295-302.
14.
GrayCMurankoH. Studies of robustness of industrial aciniform aggregates and agglomerates - carbon black and amorphous silicas: a review amplified by new data. J Occup Environ Med. 2006;48(12):1279-1290.
15.
YatesDHealyT. The structure of the silica/electrolyte interface. J Colloid Interface Sci. 1976;55(1):9-19.
16.
HurdAFlowerW. In situ growth and structure of fractal silica aggregates in a flame. J Colloid Interface Sci. 1988;122(1):178-192.
17.
U.S. Pharmacopeial Convention. Food Chemicals Codex. 8th ed.Baltimore, MD: United Book Press, Inc.; 2012.
18.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition (CFSAN). Voluntary cosmetic registration Program - frequency of use of cosmetic ingredients. College Park, MD, 2019. (Obtained under the Freedom of Information Act from CFSAN; requested as “Frequency of Use Data” January 3, 2019; received February 13, 2019).
19.
Personal Care Products Council. Council concentration of use survey: silica ingredients. Unpublished data submitted by Personal Care Products Council on October 26, 2018; 2018.
20.
RotheHFautzRGerberE, et al.Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment. Toxicol Lett. 2011;205(2):97-104.
21.
RotheH. Special aspects of cosmetic spray evaluation. Unpublished data presented at the 26 September CIR Expert Panel meeting. Washington, D.C.
22.
BremmerHPrud'homme de LodderLEngelenJ. Cosmetics Fact Sheet: To Assess the Risks for the Consumer; Updated Version for ConsExpo 4. Bilthoven, Netherlands; 2006:1-77. RIVM 320104001/2006. https://www.rivm.nl/bibliotheek/rapporten/320104001.pdf. Accessed 8/24/2011.
23.
JohnsenM. The influence of particle size. Spray Technol Mark. 2004;14(11):24-27.
24.
CIR Science and Support Committee of the Personal Care Products Council (CIR SSC). Cosmetic powder exposure. Unpublished data submitted by the Personal Care Products Council; 2015.
25.
AylottRByrneGMiddletonJRobertsM. Normal use levels of respirable cosmetic talc: preliminary study. Int J Cosmet Sci. 1976;1(3):177-186.
26.
RussellRMerzRShermanWSivertsonJN. The determination of respirable particles in talcum powder. Food Cosmet Toxicol. 1979;17(2):117-122.
27.
Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; 2009.
28.
Australian Government Department of Health. National Industrial Chemicals Notification and Assessment Scheme (NICNAS). https://www.nicnas.gov.au/chemical-information. Last Updated: Accessed: 5/1/2018.
29.
KaewamatawongTKawamuraNOkajimaMSawadaMMoritaTShimadaA. Acute pulmonary toxicity caused by exposure to colloidal silica: particle size dependent pathological changes in mice. Toxicol Pathol. 2005;33(7):743-749.
30.
JavadzadehYJafari-NavimipourBNokhodchiA. Liquisolid technique for dissolution rate enhancement of a high dose water-insoluble drug (carbamazepine). Int J Pharm. 2007;341(1-2):26-34.
31.
VillotaRHawkesJ. Food applications and the toxicological and nutritional implications of amorphous silicon dioxide. Crit Rev Food Sci Nutr. 1986;23(4):289-321.
32.
SauerFLaughlandDDavidsonW. Silica metabolism in Guinea pigs. Can J Biochem Physiol. 1959;37(2):183-191.
33.
SauerFLaughlandDDavidsonW. The silica content of Guinea pig tissues as determined by chemical and isotopic techniques. Can J Biochem Physiol. 1959;37(10):1173-1181.
34.
NewbernePWilsonR. Renal damage associated with silicon compounds in dogs. Proc Natl Acad Sci USA. 1970;65(4):872-875.
35.
TakizawaYHirasawaFNoritomiEAidaMTsunodaHUesugiS. Oral ingestion of syloid to mice and rats and its chronic toxicity and carcinogenicity. Acta Med Biol. 1988;36(1):27-56.
36.
W.R. Grace & Co. Supplement to GRAS affirmation petition No. 1G0270: silica gel for use as a carrier for flavors. Submitted by the US FDA in response to a FOI request; 1981; 189.
37.
LowRAbsherPHemenwayDGiancolaM. Bronchoalveolar lavage lipids in rats exposed to aerosolized silicon dioxide polymers. Am Rev Resp Dis. 1985;13:183.
WarheitDCarakostasMKellyDHartskyMA. Four-week inhalation toxicity study with Ludox colloidal silica in rats: pulmonary cellular responses. Fundam Appl Toxicol. 1991;16(3):590-601.
40.
WarheitDAchinkoLCarakostasMHartskyM. Testing the efficacy of biomarkers to predict pulmonary toxicity of inhaled materials. Am Rev Resp Dis. 1990;141A:419.
41.
LeeKKellyD. Translocation of particle-laden alveolar macrophages and intra-alveolar granuloma formation in rats exposed to Ludox colloidal amorphous silica by inhalation. Toxicol. 1993;77(3):205-222.
42.
WarheitDMcHughTHartskyM. Differential pulmonary responses in rats inhaling crystalline, colloidal, or amorphous silica dusts. Scand J Work Environ Health. 1995;21 Suppl 2:19-21.
43.
ReuzelPBruihintjesJReronVWoutersenR. Subchronic inhalation toxicity of amorphous silicas and quartz dust in rats. Fd Chem Toxic. 1991;29(5):341-354.
44.
ShinJJeonKKimJ, et al.Subacute inhalation toxicity study of synthetic amorphous silica nanoparticles in Sprague-Dawley rats. Inhal Toxicol. 2017;29(12-14):567-576.
45.
JohnstonCDriscollKFinkelsteinJ, et al.Pulmonary chemokine and mutagenic responses in rats after subchronic inhalation of amorphous and crystalline silica. Toxicol Sci. 2000;56(2):405-413.
46.
SchepersG. Hypertension due to inhaled submicron amorphous silica. Toxicol Appl Pharmacol. 1959;1(5):487-500.
47.
SchepersGDurkanTDelahantACreedonFRedlinA. The biological action of Degussa submicron amorphous silica dust (Dow Corning silica). I. Inhalation studies on rats. AMA Arch Ind Health. 1957;16(2):125-146.
48.
SchepersG. Biological action of precipitation-process submicron amorphous silica (HI-SIL 233). In: DDD, ed. Health Effects of Synthetic Silica Particulates, ASTM STP 732. Philadelphia: American Society for Testing and Materials; 1981:144-173.
49.
GrothDMoormannWLynchDStettlerLWagnerWHornungR. Chronic effects of inhaled amorphous silicas in animals. In: DDD, ed. Health Effects of Synthetic Silica Particulates, ASTM STP 732. Philadelphia: American Society for Testing and Materials; 1981:118-143.
50.
SchepersGDurkanTDelahantACreedonFRedlinA. The biological action of inhaled Degussa submicron amorphous silica dust (Dow Corning Silica): II. The pulmonary reaction in uninfected Guinea pigs. AMA Arch Ind Health. 1957;16(3):203-224.
51.
SchepersGDelahantASchmidtJVon WechelnJCreedonFClarkR. The biological action of Degussa submicron amorphous silica dust (Dow Corning Silica): III. Inhalation studies in rabbits. AMA Arch Ind Health. 1957;16(4):280-301.
52.
SchepersG. Reaction of monkey lung to siliceous dusts. Arch Environ Health. 1962;5(4):278-299.
53.
KanematsuNHaraMKadaT. Rec assay and mutagenicity studies on metal compounds. Mutat Res. 1980;77(2):109-116.
54.
PrivalMSimmonVMortelmansK. Bacterial mutagenicity testing of 49 food ingredients gives very few positive results. Mut Res. 1991;260(4):321-329.
55.
LiuXKeaneMZhongB-ZOngTWallaceW. Micronucleus formation in V79 cells treated with respirable silica dispersed in medium and in simulated pulmonary surfactant. Mutat Res. 1996;361(2-3):89-94.
56.
ZhongBOngTWhongW. Studies on the relationship between treatment condition and micronucleus induction in V79 cells exposed to silica and glass fibers. Mutat Res. 1997;391(1-2):111-116.
International Agency for Research on Cancer (IARC). Silica, Some Silicates, Coal Dust and Para-Aramid Fibrils, Vol 68. Lyon, France: World Health Organization; 1997.
59.
CampbellJ. Effects of precipitated silica and of iron oxide on the incidence of primary lung tumours in mice. Br Med J. 1940;2(4156):275-280.
60.
PottFRollerM. Carcinogenicity study with nineteen granular dusts in rats. Eur J Oncol. 2005;10(4):249-281.
61.
EpsteinWSkahenJKrasnobrodH. The organized epithelioid cell granuloma: differentiation of allergic (zirconium) from colloidal (silica) types. Am J Pathol. 1963;43(3):391-405.
62.
Anonymous. Safety data of hydrated silica - contact allergenicity (Translated into English in 2009). Unpublished data submitted by the Personal Care Products Council; 1984.
63.
KGL Inc. An evaluation of the contact-sensitization potential of a topical coded product (facial mask containing 17% Hydrated Silica) in human skin by means of the maximization assay. KGL Protocol #5384. Unpublished data submitted by the Personal Care Products Council; 2003.
64.
KGL Inc. An evaluation of the contact-sensitization potential of a topical coded product (face powder containing 21.7436% Silica) in human skin by means of the maximization assay. KGL Protocol #5632. Unpublished data submitted by the Personal Care Products Council; 2004.
65.
Hazelton Laboratories. Progress report no. 1; acute oral administration, acute eye application. Submitted by EPA in response to a FOI request in 2008; 1958, 66.
66.
PlunkettEDeWittB. Occupational exposure to hil-sil and silene: report of an 18-year study. Arch Environ Health. 1962;5(5):469-472.
67.
WilsonRStevensPLovejoyHBellZRichieR. Effects of chronic amorphous silica exposure on sequential pulmonary function. J Occup Med. 1979;21(6):399-402.
68.
ChoudatDFrischCBarratGel KholtiAConsoF. Occupational exposure to amorphous silica dust and pulmonary function. Br J Ind Med. 1990;47(11):763-766.
69.
VolkH. The health of workers in a plant making highly dispersed silica. Arch Environ Health. 1960;1(2):125-128.
