韩国化妆品安全管理体系及NGRA策略简介.pdf

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1、2025.7.4.in-cosmetics Korea 20251 2 3 -4 1.,2.(2024-9,2024.2.7.)3 1 :,4 2 :,6 4 :,(2023-61,2023.9.21.)3 1 ,)204(,Pyranine Conc)CI590408-1,3,6-0.01%,5 2 )204:65.0101.0%,1)2)3)4)5)6)7),1.2.3.(2020-66,2020.7.24.)1.2.3.*2024 (2024.11.5.,)(24),(,)(25),()(28)313029282726 (2)10 1),.2)(,).3),.1.()2025 (1):(

2、a):,1 ,LD50(b):(28/90/24)(,)(c):,(d):,/,(:,)(e):DNA ,DNA (f):,(injection)(),DNA DNA (g):-:,.-:,.-:/.2.:(Point Of Departure,POD)-(No Observed Adverse Effect Level,NOAEL):/-(Lowest Observed Adverse Effect Level,LOAEL):-(Benchmark Dose,BMD):-,(Benchmark Rresponse level,BMR)5%10%.BMDL(Benchmark DoseLowe

3、r confidence limit)BMD 95%.1)(systemic exposure dosage,SED),1,.-(SED)(mg/cm2)(%).,.(/cm2)(SED)SED=DAa(g/cm2)103mg/gSSA(cm2)F(day1)60(kg)(%)(SED)SED=A(g/day)x 1000mg/g C(%)/100 x DAp(%)/10060(kg)4.1)2),(PODsys)(MOS)()=3)(MOS)(),()MOS 100(-10 10)()In silico (TTC,Read-Across etc.)THE SCCS NOTES OF GUID

4、ANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION (NGRA)TTCREAD-ACROSSTier 0:,Tier 1:AB INITIO Tier 2:AB INITIO (,)Internal TTC(Mode of Action)()(,in vitro,)(PoD),in vitro/in vivo,AB INITIOTTC Cramer (TTC):(TTC)(TTC:Threshold of ToxicologicalConcern)Cramer :3 (low,medium,high

5、safety concern)(TTC):ug/kg bw/dayRIFM/Munro/Cosmos/Federated DB(Patel et al.,2020)Cosmos/Munro/Federated DB(Yang et al.,2017)Cosmos-TTC(SEURAT-1;European commission,2009)SCCP/1171/08(Munro et al.1996)Cramer class :ug/day:ug/kg bw/day0.0025 Genotoxic compounds 49.12,760464230 I*12.7Not supported*-Not

6、 supported*II*2.91382.37.91.5III*Non-genotoxic compounds*Chemicals of Cramer class II should be treated as Class III substances.Values in bold are those currently recommended by the SCCS for use for cosmetics-related substances.THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND T