JOURNAL OF COSMETIC SCIENCE 182 according to the results in all of the formulations. This result is thought to be due to the use of zinc oxide with antimicrobial properties in all formulations between 7 and 27%. PARTICLE SIZE ANALYSIS AND ZETA POTENTIAL (Ζ) RESULTS A ccording to the results in Table 4, the ideal particle size range was found between 100 and 1,000 nm, and it is considered ideal for effective cosmetic products. Also, polydis- persity index (PDI) 0.5 indicates a homogeneous distribution in all formulations. The zeta potential, particle size (nm), and PDI values of BBC 8- (K13/092) optimum formu- lation were zeta potential = (-30.9 ± 0.72), particle size = (533.2 ± 6.93 nm), and PDI = (0.370 ± 0.03), respectively. Figure 2. HLB and emulsifi er percentage calculation chart of all formulations.
NEXT-GENERATION NATURAL BABY BARRIER CREAM FORMULATIONS 183 SAFET Y ASSESSMENT RESULT OF OPTIMUM FORMULATION A saf ety assessment study of BBC-8 formulation was carried out according to the Annex I of Regulation (EC) No 1223/2009 guideline (29). BBC-8 formulation safety assessment results are given in the following text. Area of the skin which is in contact with the product: 200 cm2. Amoun t of applied cream: 0.05 g. Conta ct time and frequency: 30 s and two times. Norma l and reasonably foreseeable exposure route: diaper rash area and topical route (no involuntary exposure). Targe t group: infant and toddler. 3mg DAa – ×SSA cm2 ×f day –1 cm2 g SED= 3.5 average infant weight body ¬ Ng ×10 ® N –1 50000/200 g/cm2 × 10–3 mg/Ng × 200 cm2 × 2 day SED= 3.5 average newborn weight N SE D = 28.571 mg/kg. NOAEL MoS= × Conc.% p100 SED *MoS values of each raw material of BBC-8 formulation are given in Table 7. It was n ecessary to calculate this exposure to assess the potential risk of each sub- stance. Individual exposure to the substances was calculated from the quantitative composition of the product. When calculating dermal absorption, calculations were made with the assumption that 100% of the product will be absorbed as the worst exposure scenario. MoS (safety limits for all substances/MoS) values of all substances in the formulation are given in Table 7 all of the MoS values were above 230. It has Table 4 Particle size, PDI, and Zeta Potential (ζ) Results of BBC Formulations (n = 3) Name Particle size (nm) PDI Zeta potential (ζ) (mV) BBC-1 508 ± 49.91 0.481 ± 0.01 -35.2 ± 2.55 BBC-2 367.5 ± 40.83 0.491 ± 0.07 -31.8 ± 1.80 BBC-3 609.3 ± 10.20 0.512 ± 0.08 -9.5 ± 0.79 BBC-4 513.4 ± 77.15 0.541 ± 0.08 -20.2 ± 1.85 BBC-5 741.4 ± 19.74 0.545 ± 0.07 -23.2 ± 1.00 BBC-6 584.1 ± 36.42 0.619 ± 0.11 -26.6 ± 0.20 BBC-7 521.2 ± 5.10 0.490 ± 0.05 -25.6 ± 0.76 BBC-8 533.2 ± 6.93 0.370 ± 0.03 -30.9 ± 0.72
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