Premix for infrared radiation protection, composition for infrared radiation protection, method for blocking infrared radiation, and use of rock nanoparticles

Abstract

The present invention pertains to the fields of cosmetology, nanotechnology, materials engineering, and related sciences. More specifically, the invention relates to a premix for infrared radiation protection comprising rock nanoparticles, to a process for preparing a composition, and to a composition for enhanced infrared radiation protection. Additionally, it discloses a method for blocking infrared radiation and the use of rock nanoparticles for blocking infrared radiation. The premix and the composition of the invention comprise rock nanoparticles, particularly basalt rock nanoparticles, plutonic rock nanoparticles, or combinations thereof, and provide advantageous and surprising effects.

Description

Premix for protection against infrared radiation, composition for protection against infrared radiation, method for blocking infrared radiation and use of rock nanoparticles. Field of Invention

[0001] This report covers confidential knowledge, information, and / or data usable in industry, commerce, or service provision, for which the holder requests: the protection established in item XXIX of Article 5 of the Federal Constitution; the maintenance of the legal status of confidentiality / secrecy; the maintenance of the physical status of confidentiality / secrecy for the time period stipulated in Law 9.279 / 96, the Industrial Property Law; and the rights provided for in Article 195 of Law 9.279 / 96. The present invention falls within the fields of Cosmetology, nanotechnology, materials engineering, and related sciences. More specifically, the invention relates to a premix comprising rock nanoparticles, a process for preparing a composition, and an improved composition. Additionally, it discloses a method for blocking infrared radiation and the use of basalt nanoparticles to block infrared radiation.The premix and composition of the invention comprise rock nanoparticles, particularly basaltic rock nanoparticles, plutonic rock or combinations thereof, and provide advantageous and surprising effects. Background of the Invention

[0002] Among the physical sunscreens available on the market, titanium dioxide is the most commonly used, followed by zinc oxide and hydroxyapatite. This ingredient represented a market of 14.5 million euros in 2019 for all its applications; it is a colorant used in cosmetics, food, medicines, and paints as a bleaching agent.

[0003] Although it is the most common physical sunscreen, this ingredient presents problems such as: a whitish appearance on the skin, a pasty feel, poor spreadability, and incompatibility with some cosmetic vehicles. Furthermore, Titanium Dioxide has been banned from use in the food industry in the European Union due to its carcinogenic potential.

[0004] Volcanic rocks containing plagioclase and pyroxene (components of basalt fiber) are found, for example, throughout the Central-South region of Brazil in the geological formation known as the Serra Geral Formation (FSG).

[0005] Adding value to materials extracted from nature is a constant challenge in the technical field of materials engineering. The current high demand for materials for a wide variety of applications makes the development of alternatives to the most commonly used materials fundamental. Furthermore, adding value relates to the more rational use of materials extracted from nature. For example, basaltic rocks from the Serra Geral Formation (FSG) are more commonly used for the production of paving stones and construction materials, such as basements, sinks, and sidewalks.

[0006] Thus, the development of new materials based on available resources to obtain alternative materials for high-tech applications is a constant demand in the field of materials engineering, and technologies in this technical area can have a significant impact on the economic development of a region, as well as a significant environmental impact by promoting the more rational use of materials extracted from nature.

[0007] Therefore, its incorporation into high value-added products is a constant need in the technical field.

[0008] The near-infrared spectrum corresponds to the spectrum between 760 nm and 1 mm, this being the main range of infrared light emitted by sunlight.

[0009] It has been observed that the near-infrared spectrum has the ability to penetrate the epidermal and dermal layers of the skin. Additionally, exposure to this wavelength is associated with increased production of matrix metalloproteinases, which are related to increased collagen degradation in the skin. This data reinforces the importance of protecting the skin from this wavelength.

[0010] Thus, the present invention provides an alternative for providing protection against infrared wavelength radiation not only to the skin but also to other types of surfaces that benefit from protection against infrared wavelength radiation.

[0011] Patent document KR101365256B1 describes a makeup composition using a "Scoria" powder. That document does not describe a premix or composition as defined in the present invention.

[0012] Patent document KR20030015524A describes a composition and its preparation, being a water-based paint composition. That document does not describe a premix or composition as defined in the present invention.

[0013] Patent document KR100823113B1 describes a cosmetic composition for protection against ultraviolet radiation. That document does not describe a premix or composition as defined in the present invention.

[0014] Thus, based on the literature reviewed, no documents were found that anticipated or suggested the teachings of the present creation / secret / invention. The invention now revealed possesses, in the eyes of the inventors, novelty and inventive activity in relation to the state of the art. Summary of the Invention

[0015] The invention provides a premix for preparing a composition, a process for preparing a composition, and an improved composition. Wherein said premix and the composition of the invention comprise rock nanoparticles, particularly basaltic rock particles, plutonic rock, or combinations thereof.

[0016] In one embodiment, the premix comprises basaltic or plutonic rock nanoparticles.

[0017] In one embodiment, the premix comprises basalt rock nanoparticles, serving as a premix for protection against infrared radiation.

[0018] In one embodiment, the premix can be prepared already as a stable colloidal suspension, thus offering a subsequent advantage for those who add it to a cosmetic formulation. This advantage is realized in the reduction of mixing times, regardless of the base, as these differ from TiO2 and other available materials that are supplied in dry powder form, since these require a costly and laborious dispersion step when incorporated into the final cosmetic mixture.

[0019] In the context of the present invention, the expression "basaltic rock nanoparticle" encompasses various chemical entities comprising basaltic rock composition as defined by the TAS diagram (Total-Alkali vs. Silica diagram, which is known to one skilled in the art - % by mass of Na2O + K2O by % by mass of Si2O). Including but not limited to Basalt, Basaltic Andesite, Andesite and Dacite as defined in the TAS diagram.

[0020] Specifically, this basaltic rock is obtained from the Central-South region of Brazil in the geological formation known as the Serra Geral Formation (FSG).

[0021] In the context of the present invention, the expression "plutonic rock nanoparticle" encompasses particles of various chemical entities formed by the cooling of magma at depth, that is, within the lithosphere, in such a way that the material does not erupt to the Earth's surface. They are also known as intrusive rocks. Including but not limited to granite, diorite, tourmaline, syenite, and gabbro.

[0022] In a first aspect, the present invention defines a premix for infrared radiation protection comprising rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof.

[0023] In a second aspect, the present invention defines a process for preparing a composition comprising a step of mixing a premix from the first aspect with one or more excipients.

[0024] In a third aspect, the present invention defines a composition for protection against infrared radiation comprising one or more excipients and rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof.

[0025] In a fourth aspect, the present invention defines a method for blocking infrared radiation comprising at least one step of applying rock nanoparticles to a surface, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof.

[0026] In a fifth aspect, the present invention defines a use of rock nanoparticles for manufacturing a composition to block infrared radiation, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof.

[0027] These and other objects of the invention will be immediately appreciated by those skilled in the art and by companies with interests in the segment, and will be described in sufficient detail for their reproduction in the following description.

[0028] The following figures are presented:

[0029] Figure 1 illustrates the particle size distribution (PSD) via image analysis for the rock sample.

[0030] Figure 2 shows images obtained by transmission electron microscopy of the dispersed rock sample without surfactants and in the presence of surfactants.

[0031] Figure 3 shows the particle size distribution curves obtained for the rock sample (SN 20 002).

[0032] Figure 4 shows the cumulative volume size distribution curves obtained for the rock sample (SN 20 002).

[0033] Figure 5 illustrates the results obtained for light transmission protection after application of the sample containing 5% by weight of the premix of the present invention (NV.1451.02) comprising basaltic rock for the wavelength spectrum between 750 and 1000 nm, corresponding to the infrared spectrum, in comparison to the control group.

[0034] Figure 6 illustrates the results obtained for light transmission protection after application of the sample containing 10% by weight of the premix of the present invention (NV.1452.02) comprising basaltic rock for the wavelength spectrum between 750 and 1000 nm, corresponding to the infrared spectrum, in comparison to the control group.

[0035] Figure 7 shows a representative graph of the percentage of silicon dioxide found in each of the three layers of the skin from an assay with Franz cells. Detailed Description of the Invention

[0036] The invention provides a premix for preparing a composition, a process for preparing a composition, and an improved composition. Wherein said premix and the composition of the invention comprise rock nanoparticles, particularly basaltic rock nanoparticles, plutonic rock, or combinations thereof.

[0037] In one embodiment, the premix can be prepared already as a stable colloidal suspension, thus offering a subsequent advantage for those who add it to a cosmetic formulation. This advantage is realized in the reduction of mixing times, regardless of the base, as these differ from TiO2 and other available materials that are supplied in dry powder form, since these require a costly and laborious dispersion step when incorporated into the final cosmetic mixture.

[0038] In the context of the present invention, the expression "basaltic rock nanoparticle" encompasses various chemical entities comprising basaltic rock composition as defined by the TAS diagram (Total-Alkali vs. Silica diagram, which is known to one skilled in the art - % by mass of Na2O + K2O by % by mass of Si2O). Including but not limited to Basalt, Basaltic Andesite, Andesite and Dacite as defined in the TAS diagram.

[0039] Specifically, this basaltic rock is obtained from the Central-South region of Brazil in the geological formation known as the Serra Geral Formation (FSG).

[0040] In the context of the present invention, the expression "plutonic rock nanoparticle" encompasses particles of various chemical entities formed by the cooling of magma at depth, that is, within the lithosphere, in such a way that the material does not erupt to the Earth's surface. They are also known as intrusive rocks. Including but not limited to granite, diorite, tourmaline, syenite, and gabbro.

[0041] In a first aspect, the present invention defines a premix for infrared radiation protection comprising rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof.

[0042] In one embodiment, the premix comprises basaltic or plutonic rock nanoparticles.

[0043] In one embodiment, the premix comprises basaltic rock nanoparticles.

[0044] In one embodiment, the premix comprises plutonic rock nanoparticles. In one embodiment, said plutonic rock is granite.

[0045] In one embodiment, the premix comprises up to 80% by weight of rock nanoparticles. In one embodiment, the premix comprises up to 85% by weight of rock nanoparticles. In one embodiment, the premix comprises up to 90% by weight of rock nanoparticles. In one embodiment, the premix comprises up to 95% by weight of rock nanoparticles. In one embodiment, the premix comprises up to 99% by weight of rock nanoparticles.

[0046] In one embodiment of the premix, the aforementioned rock nanoparticles comprise a particle size distribution profile being: d10: between 130 and 155 nm; d50: between 400 and 520 nm; and d90: between 5000 and 8000 nm.

[0047] In a second aspect, the present invention defines a process for preparing a composition comprising a step of mixing a premix from the first aspect with one or more excipients.

[0048] In a third aspect, the present invention defines a composition for protection against infrared radiation comprising one or more excipients and rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof.

[0049] In one embodiment, the composition comprises up to 10% by weight of rock nanoparticles. In one embodiment, the composition comprises from 1% to 10% by weight of rock nanoparticles. In one embodiment, the composition comprises from 5% to 10% by weight of rock nanoparticles.

[0050] In one embodiment, the aforementioned rock nanoparticles comprise a particle size distribution profile being: d10: between 130 and 155 nm; d50: between 400 and 520 nm; and d90: between 5000 and 8000 nm.

[0051] In one application, the composition has a high level of protection against infrared radiation.

[0052] In one specific application, the composition is for skin protection against infrared radiation.

[0053] In one application, the composition is designed for thermal comfort. In one application, the composition reduces the sensation of thermal discomfort when exposed to conditions that increase temperature, regardless of the source.

[0054] In a fourth aspect, the present invention defines a method for blocking infrared radiation comprising at least one step of applying rock nanoparticles to a surface, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof.

[0055] In practical application, the method aims to reduce the sensation of thermal discomfort when exposed to conditions that increase temperature, regardless of the source.

[0056] In a fifth aspect, the present invention defines a use of rock nanoparticles for manufacturing a composition to block infrared radiation, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof.

[0057] In one specific application, these rock nanoparticles are composed of basaltic rock.

[0058] In one embodiment, the use is for manufacturing a composition to block infrared radiation incident on an individual's skin.

[0059] The examples shown here are intended only to illustrate one of the numerous ways of carrying out the invention, without, however, limiting its scope.

[0060] Example 1 – Characterization of the rock sample

[0061] The rock sample was received in suspension. The suspension was subjected to drying at 100 °C for 12 hours in an oven. The dried sample was analyzed by X-ray Fluorescence (XRF).

[0062] The rock sample was also analyzed for particle size distribution (PSD) via image analysis. Figure 1 illustrates the particle size distribution (PSD) via image analysis for the rock sample.

[0063] The DTP results show a broad distribution with a higher frequency for particles around 25-30 nm. Sample preparation using the conventional method allowed for obtaining images suitable for DTP analysis.

[0064] The samples were also analyzed by transmission electron microscopy (TEM). Figure 2 shows images obtained by transmission electron microscopy of the dispersed rock sample without surfactants and in the presence of surfactants.

[0065] Images without surfactant showed particles with irregular morphology and particle sizes between 0.5 and 1 µm. Clusters with a size of approximately 3 µm were observed. On the other hand, nanoparticles with sizes between 30 and 50 nm, adhered to larger particles, were also observed.

[0066] The use of surfactant, despite decreasing image quality and making DTP analysis more difficult, dispersed the 30-50 nm particles that were attached to larger particles and revealed that these particles are predominantly present.

[0067] Example 2 – Characterization of particles by zeta potential and particle size

[0068] 50 g of suspension were prepared from each sample, containing 10 wt% solids. Approximately 5 g of powder were added to 45 g of distilled water. The suspension was dispersed and homogenized in a Hielscher UP400St ultrasonic processor for 15 min, with a cycle of 0.8 and an amplitude of 80%.

[0069] Zeta potential analyses were performed using a Stabino 2.0 Particle Metrix instrument. Zeta potential calibration was performed with a 50 mV alumina suspension. Streaming potential calibration was performed with a 0.0025 N P-DADMAC solution (N / 400). pH calibration was performed with pH 4 and 7 buffer solutions. Electrical conductivity calibration was performed with a standard potassium chloride (KCl) solution of 1412 μS / cm. Three analyses were performed for each sample (the sample was removed and a new aliquot was placed in the instrument), with 21 acquisition points in each analysis.

[0070] An attempt was made to analyze particle size distribution using DLS on the Nanotrac Flex Microtrac Retsch instrument. However, it was observed that the coarser particles sedimented rapidly and were not "identified" in the analysis, since the suspension sample remained static. Therefore, the results obtained by this method would not reflect the particle size distribution in its entirety.

[0071] Particle size distribution analyses by SLS were performed on an Analysette22 NanoTec Fritsch instrument. The analyses were performed using the "Mie" calculation method (considering a refractive index of 2.3 for SN 10 004 and 1.5 for SN 20 002). Three analyses were performed for each sample (the sample was removed and a new aliquot was placed in the instrument), with three measurements for each analysis. The analyses were performed with the sample under agitation and with the application of ultrasound from the instrument itself. Summary of results

[0072] The summary compiling the average values ​​obtained for the Rock samples (SN 20 002) from all the characterization analyses performed is presented in Table 1. The detailed results for each of the analyses are presented in sections 2.2 (Zeta Potential) and 2.3 (Particle Size).

[0073] Table 1. Property of Rock (SN 20 002). Electrical Conductivity (µS / cm) 174.1. pH 9.4. Zeta Potential (mV) -43.0. d10 (nm) 141.2. d50 (nm) 448.8. d90 (nm) 6536.7. *average values

[0074] The results for zeta potential, pH, and electrical conductivity obtained for the rock suspension samples (SN 20 002) are presented in Table 2.

[0075] Table 2SN 20 002 Zeta Potential (mV) pH Electrical Conductivity (µS / cm) Analysis 1 -4 1.8 9.4 172.7 Analysis 2 -4 3.3 9.5 174.3 Analysis 3 -4 4.0 9.4 175.3 Average -4 3.0 9.4 174.1

[0076] The particle size results d10, d50 and d90 obtained for the Rock samples (SN 20 002) are presented in Table 3. The particle size distribution curves and accumulated volume obtained for the Rock sample (SN 20 002) are presented in Figure 3 and Figure 4.

[0077] Table 3SN 20 002d10 (nm)d50 (nm)d90 (nm)Analysis 1.1147.72515.827585.24Analysis 1.2136.93455.397985.35Analysis 1.3132.79419.155915.51Analysis 2.1132.51407.075573.82Analysis 2.2132.13403.455706.92Analysis 2.3152.82485.886363.49Analysis 3.1152.19472.825646.10Analysis 3.2141.97442.117295.82Analysis 3.3141,44437,756757.74Average141,17448,826536.66

[0078] Example 3 – Sample's ability to absorb light passing through at infrared wavelengths.

[0079] Using equipment that emits and measures the passage of light at different wavelengths, it is possible to observe whether products have the ability to absorb a specific wavelength of infrared light.

[0080] In this example, a sample comprising 5% by weight of the premix of the present invention, comprising basalt rock with the following composition as shown in Table 4, was tested.

[0081] Table 4 – Composition of sample NV.1451.02 Compound CAS Number % by weight Water 7732-18-560.39 Capric and caprylic acid triglycerides 73398-61-5 / 65381-09-110.00 Premix -5.00 Coco-caprylate -5.00 Undecane 1120-21-43.50 Propanediol 504-63-2 / 26264-14-23.00 Cetyl alcohol 36653-82-43.00 Glycerin 56-81-52.00 Cetearyl olivate -1.80 Tridecane 629-50-51.50 Sorbitan olivate 223706-40-91.20 Cetearyl alcohol 67762-27-0 / 8005-44-50.80Cetyl palmitate540-10-3 / 97404-33-60.60hydroxyacetophenone99-93-40.50Hydroxyethylcellulose9004-62-00.50Sorbitan palmitate26266-57-9 / 5050-91-90.40Oleate sorbitan1338-43-8 / 37318-79-90,201,2-hexanediol6920-22-50,25Caprylyl glycol1117-86-80,25Tocopherol acetate7695-91-2 / 58-95-70,10Sodium hydroxide1310-73-20.01

[0082] The sample was applied to a surface that does not interfere with the sample's ingredients, in a uniform manner, at a concentration of 2 mg / cm². 2Next, the sample was dried at room temperature in the dark for at least 30 minutes before being read.

[0083] The equipment used for analysis was the Thermo Fischer Multiskan Spectrophotometer. Wavelengths between 750 and 1000 nm were used, and 3 different measurements were performed. The measurements were taken of the absorbance of the sample at each wavelength. Measurements were also taken of the surface to which the sample was applied in isolation.

[0084] The data acquired from the absorbance of the sample and the surface are used to calculate the shielding provided by the sample against the passage of light at the analyzed wavelengths.

[0085] Figure 5 shows the results obtained for light transmission protection after application of sample NV.1451.02, comprising basaltic rock, for the wavelength spectrum between 750 and 1000 nm, corresponding to the infrared spectrum, compared to the control group. It can be observed that sample NV.1451.02 demonstrated protection across the entire analyzed spectral range.

[0086] Therefore, it can be concluded that sample NV.1451.02 protects against the passage of infrared radiation.

[0087] In view of all the results found, it can be observed that particularly surprising results were obtained from the use of nanometric basaltic rock particles.

[0088] Example 4 – Sample's ability to absorb light passing through at infrared wavelengths.

[0089] Using equipment that emits and measures the passage of light at different wavelengths, it is possible to observe whether products have the ability to absorb a specific wavelength of infrared light.

[0090] In this example, a sample comprising 10% by weight of the premix of the present invention, comprising basaltic rock with the following composition as shown in Table 5, was tested.

[0091] Table 5 – Composition of sample NV.1452.02 Compound CAS Number % by weight Water 7732-18-555.39 Capric and caprylic acid triglycerides 73398-61-5 / 65381-09-110.00 Premix -10.00 Coco-caprylate -5.00 Undecane 1120-21-43.50 Propanediol 504-63-2 / 26264-14-23.00 Cetyl alcohol 36653-82-43.00 Glycerin 56-81-52.00 Cetearyl olivate -1.80 Tridecane 629-50-51.50 Sorbitan olivate 223706-40-91.20 Alcohol Cetearyl 67762-27-0 / 8005-44-50.80 Cetyl palmitate 540-10-3 / 97404-33-60.60 Hydroxyacetophenone 99-93-40.50 Hydroxyethylcellulose 9004-62-00.50 Sorbitan palmitate 26266-57-9 / 5050-91-90.40 Sorbitan oleate 1338-43-8 / 37318-79-90.20 1,2-hexanediol 6920-22-50.25 Caprylyl glycol 1117-86-80.25 Tocopheryl acetate 7695-91-2 / 58-95-70.10 Sodium hydroxide 1310-73-20.01

[0092] The sample was applied to a surface that does not interfere with the sample's ingredients, in a uniform manner, at a concentration of 2 mg / cm². 2Next, the sample was dried at room temperature in the dark for at least 30 minutes before being read.

[0093] The equipment used for analysis was the Thermo Fischer Multiskan Spectrophotometer. Wavelengths between 750 and 1000 nm were used, and 3 different measurements were performed. The measurements were taken of the absorbance of the sample at each wavelength. Measurements were also taken of the surface to which the sample was applied in isolation.

[0094] The data acquired from the absorbance of the sample and the surface are used to calculate the shielding provided by the sample against the passage of light at the analyzed wavelengths.

[0095] Figure 6 shows the results obtained for light transmission protection after application of sample NV.1452.02, comprising basaltic rock, for the wavelength spectrum between 750 and 1000 nm, corresponding to the infrared spectrum, compared to the control group. It can be observed that sample NV.1452.02 demonstrated protection across the entire analyzed spectral range.

[0096] Therefore, it can be concluded that sample NV.1452.02 protects against the passage of infrared radiation.

[0097] In view of all the results found, it can be observed that particularly surprising results were obtained from the use of nanometric basaltic rock particles.

[0098] Example 5 – Evaluation of in vitro genotoxicity through micronucleus assay of rock particle sample against the CHO-K1 test system.

[0099] The aim of the study was to evaluate the rock particle sample regarding its ability to cause chromosomal damage or other significant effects on cell division that could lead to the formation of micronuclei in interphase cells of the CHO-K1 test system (ST-035-23).

[0100] The CHO-K1 strain is established for genotoxicity assays according to OECD-487-Jul 2023 reference guideline. Extensive data support the validity of the micronucleus test using the ST-035-23 test system (1, 2).

[0101] Table 6 - Test System Identification Description Identification Test System Name CHO-K1 Test System Code ST-035-23 Origin Cricetulus griseus Lot Number 001668 Morphology Epithelial Growth Conditions F12 10% FBS Transition p+10 to p+15

[0102] The study was conducted using two different exposure periods to the test item: a 24-hour period (long exposure) and a 3-hour period (short exposure). During the short exposure period, two assays were performed with and without metabolic activation. After a dose assay adjusted for the characteristics of this test item, slides of the concentrations considered high and two lower concentrations were selected for microscopic analysis: 0.039 mg / mL, 0.019 mg / mL, and 0.009 mg / mL.

[0103] The following equation was used to calculate the Binucleated Cell Proliferation Index (CBPI):

[0104] (Equation 1)

[0105] The Replication Index (RI), which indicates the relative number of nuclei compared to controls, was determined using equation 2 below:

[0106] (Equation 2)

[0107] Where: t = treatment with test item or positive control; c = culture without treatment.

[0108] Cytotoxicity (%) is expressed as (100 - RI) according to equation 3 below:

[0109] (Equation 3) Metabolic activation system

[0110] A mix was prepared with a commercial S9 solution containing 180 mg / mL glucose-6-phosphate, 25 mg / mL NADP, 0.15 M KCl, and S9 in a 1:1:1:2 (v / v) ratio. Aliquots of this mixture were added to the cell cultures of the test system (ST-035-23) at a final concentration of 2% v / v. Analysis of the slides

[0111] All slides, including positive and negative controls, were independently coded before microscopic analysis. At least 2000 cells (binucleated due to the use of cytochalasin B) were evaluated for each test concentration. Micronuclei (MN) demonstrated staining characteristics similar to those of the main nucleus, possessed a clearly defined membrane, were separated from the main nucleus, and had a diameter no greater than one-third the diameter of the main nucleus. Interpretation of results

[0112] Positive: IDT will be classified as genotoxic under the following conditions: i. At least one of the test concentrations reveals a statistically significant increase compared to the negative control with significance above 95% (p<0.05). ii. The observed increase in micronucleus cells is dose-correlated in at least one experimental condition.

[0113] Negative: IDT will be categorized as non-genotoxic when: i. None of the test concentrations demonstrate a statistically significant increase compared to the negative control. ii. There is no concentration-related increase in micronucleus cells. Results obtained

[0114] After the counting and decoding of the slides was completed, the numbers of binucleated cells with micronuclei (MNBN cells) were obtained in each experiment (tables 7 to 9).

[0115] Table 7: 24-hour exposure to rock particle sample without metabolic activation (-S9) Identification Concentration CBPRIC Cytotoxicity (%) Micronucleus frequency (%) Negative control -1.655 100.000 -0.147 Positive control Mitomycin C 0.2 µg / mL 1.617 98.38 31.617 0.797 IDT -0.24 -230.03 mg / mL a 1.740100.540-0.293IDT-024-230.019 mg / mL1.707101.520-0.0IDT-024-230.0095 mg / mL b 1,75298,5791,4210,149 aThe highest concentrations selected were the maximum practicable concentrations, limited by the accumulation of test item in the test system observed at the end of the treatment period.

[0116] b The count of binucleated cells was below the required level due to interference in the cytoplasm of the cells.

[0117] Table 8: 3-hour exposure to rock particle sample without metabolic activation (-S9) Identification Concentration CBPRIC Cytotoxicity (%) Micronucleus frequency (%) Negative control -1.620 100.000 -0.547 Positive control Mitomycin C 0.2 µg / mL 1.550 99.85 10.149 1.893 IDT -0.24 -230.03 mg / mL a 1,72999,9500,0500,344IDT-024-230,019 mg / mL1,71199,8010,1990,249IDT-024-230,0095 mg / mL1,69599,7510,2490,150 a The highest concentrations selected were the maximum practicable concentrations, limited by the accumulation of test item in the test system observed at the end of the treatment period.

[0118] Table 9: 3-hour exposure to a sample of rock particles with metabolic activation (+S9) Identification Concentration CBPRIC Cytotoxicity (%) Micronucleus frequency (%) Negative control -1.714 100.000 -0.437 Positive control Mitomycin C 0.2 µg / mL 1.615 97.475 2.525 1.644 IDT -0.24 -230.03 mg / mL a 1,72097,3292,6710,399IDT-024-230,019 mg / mL1,72597,6202,3800,448IDT-024-230,0095 mg / mL1,82397,6202,3800,498 a The highest concentrations selected were the maximum practicable concentrations, limited by the accumulation of test item in the test system observed at the end of the treatment period.

[0119] The frequency of micronucleated binucleated cells (MNBN) in the negative control remained within the normal range. Cells treated with the positive control were characterized by a significant increase in the frequency of cells with micronuclei. All acceptability criteria were met.

[0120] Table 10: Overview of results obtained Treatment Identification Concentration Genotoxicity 3-hour exposure without metabolic activation (-S9) Negative control -- Positive control Mitomycin C 0.2 µg / mL Genotoxic IDT-024-230.03 mg / mL a Non-genotoxic IDT-024-230.019 mg / mL Non-genotoxic IDT-024-230.0095 mg / mL Non-genotoxic 3-hour exposure with metabolic activation (+S9) Negative control -- Positive control Mitomycin C 0.2 µg / mL Genotoxic IDT-024-230.03 mg / mL a Non-genotoxic IDT-024-230.019 mg / mL Non-genotoxic IDT-024-230.0095 mg / mL Non-genotoxic 24-hour exposure without metabolic activation (-S9) Negative control -- Positive control Mitomycin C 0.2 µg / mL Genotoxic IDT-024-230.03 mg / mL a Non-genotoxic IDT-024-230.019 mg / mL Non-genotoxic IDT-024-230.0095 mg / mL Non-genotoxic aThe highest concentrations selected were the maximum practicable concentrations, limited by the accumulation of test item in the test system observed at the end of the treatment period.

[0121] With regard to the treatment of cells with the rock particle sample of the present invention (IDT-024-23), both in the absence and presence of the S-9 metabolic activation system, it was observed that, in both experiments, the frequencies of MNBN cells remained similar and did not show statistically significant differences (p ≤ 0.05) compared to the frequencies observed in the negative controls, at all concentrations and exposures evaluated.

[0122] Furthermore, a precipitate, possibly originating from the evaluated test item, visible under an inverted microscope, with an emulsion-like appearance, adhered to the test system, is reported. This precipitate is recorded as an observed alteration and, in higher concentrations, may render cytological assays unfeasible due to its representation in the form of artifacts.

[0123] It is concluded that the rock particle sample of the present invention did not exert genotoxic effects on CHO-K1 cells. The absence of genotoxic effects was verified under two distinct experimental modalities, characterized by short and long exposure periods to the evaluated test item, until reaching the maximum viable concentration. This non-genotoxicity profile was consistently observed both in the presence and absence of the S9 metabolic activation system.

[0124] Example 6 – Microbiological analysis

[0125] The results of the microbiological analysis of a rock sample (SN 20 002) are shown in Table 11 below:

[0126] Table 11 Determination Result Unit Aerobic Mesophilic Bacteria Count <10 CFU / g Mold and Yeast Count <10 CFU / g Total Coliforms Absent Absent Fecal Coliforms Absent Absent Pseudomonas aeruginosa Absent Absent Staphylococcus aureus Absent Absent Method Reference: USP – United States Pharmacopeia The result obtained has restricted meaning and refers only to the samples analyzed. Acceptable reference values: RDC No. 752, of September 19, 2022 - Provides for the definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as the technical requirements and procedures for the regulation of personal hygiene products, cosmetics and perfumes.

[0127] The results of the microbiological analysis confirm the biological safety of the rock sample (SN 20 002).

[0128] Example 7 – Skin permeation of the rock sample (SN 20 002)

[0129] Skin permeation test results were obtained using silicon dioxide as a marker with Franz cells. Based on these results, it was possible to create a simplified visualization graph showing the percentage permeated in each of the three skin layers monitored in the study. The results are summarized in Table 12:

[0130] Table 12Rocha (SN 20 002)% permeation 1Skin layers%Stratum corneum95.21Epidermis2.21Dermis2.58

[0131] Figure 7 shows a representative graph of the percentage of silicon dioxide found in each of the three layers of the skin.

[0132] Of the total silicon dioxide applied, 95% remained in the stratum corneum, demonstrating low cutaneous permeation of the material. This result, combined with the results of absence of genotoxicity, low cytotoxicity, and absence of dermal sensitization, leads us to conclude that Rocha's material (SN 20 002) proves to be safe for cosmetic application.

[0133] Example 8 – Sensory skin test of the composition of the present invention

[0134] A sensory test was conducted by a trained professional with a composition of the present invention containing the basalt rock nanoparticle premix by exposing the skin to UV-emitting lamps.

[0135] Based on the tests, it was found that there is a sensation of greater thermal comfort on the skin when applying the composition of the present invention containing the basalt rock nanoparticle premix when compared to a composition that does not contain said particles.

[0136] Thus, in addition to the results already shown, it has been proven that the composition of the present invention reduces the sensation of thermal discomfort when exposed to conditions of increased temperature, regardless of the source.

[0137] In view of all the results found, it can be observed that particularly surprising results were obtained from the use of nanometric basaltic rock particles.

[0138] Example 9 – Infrared (IR) protection factor

[0139] The solar spectrum is composed of a series of radiations, and almost all of them can act beneficially. However, when the amount of energy absorbed exceeds the tolerable dose, risks are inevitable. The main solar radiations are: Infrared rays, responsible for the sensation of heat and dehydration of the skin during sun exposure; UVA (320-400nm), which tan superficially, but contribute to premature skin aging induced by prolonged sun exposure; they pass through most common glass. Depending on the thickness of the skin, they can reach dermal tissues, which makes them as dangerous as the higher energy wavelengths (UVB). The UVA range can be subdivided into low UVA, from 320-340 nm, responsible for the vast majority of the physiological effects of UVA on the skin, and high UVA, from 340-400 nm, responsible for very small changes in elastic fibers; UVB rays (290-320 nm) are considered more harmful than UVA radiation.They have little penetration into the skin, but due to their high energy, they are largely responsible for the immediate damage from solar radiation and for a good part of the delayed damage. They are also responsible for the transformation of epidermal ergosterol into vitamin D. In excess, they cause erythema (sunburn), premature aging, and skin cancer, mainly affecting people with fair skin; UVC (100-290nm) are quite harmful, do not stimulate tanning, and cause sunburn and cancer. Some studies have detected a slow destruction of the ozone layer caused by CFCs (chlorofluorocarbons), a family of gases used until recently as propellants in aerosols and refrigeration. The consequences of this destruction have not yet been fully assessed, but will undoubtedly greatly affect life on the planet.

[0140] In this example, the radiation protection factor at infrared wavelengths was studied. The experimental conditions used are accepted and consistent with the methodologies currently applied in the international scientific community.

[0141] The results were obtained for protection against radiation at wavelengths greater than 750 nm, particularly between 750 and 1000 nm. It is observed that the composition demonstrated protection across the entire analyzed spectrum. According to the results obtained, it is possible to affirm that the sample demonstrates a high protection factor, especially against radiation in the infrared range, corroborating the results regarding the reduction of thermal discomfort.

[0142] The applicant, by filing this application with the competent / guarantor body, seeks and intends to: (i) name the authors / inventors in respect of their respective moral, copyright and patrimonial rights related to their works; (ii) unequivocally indicate that he / she possesses the trade or industrial secret and holds any form of intellectual property derived therefrom and desired by the applicant; (iii) describe in detail the content of the creations and the secret, proving its existence in physical and legal terms; (iv) obtain protection for his / her intellectual creations, as provided for in the Copyright Law; (v) establish the relationship between the examples / implements and the creative, ornamental, distinctive or inventive concept according to the applicant's understanding and context, to clearly demonstrate the scope of his / her protected and / or protectable intangible asset;(vi) to request and obtain the additional rights provided for in patents, if the applicant chooses to proceed with the administrative procedure to the end.;

[0143] Any future disclosure or publication of this document does not, in itself, constitute authorization for commercial use by third parties. Even if the content becomes part of the physical world accessible to third parties, the disclosure or publication of this document under the terms of the law does not eliminate its legal status as a secret, serving only and solely the spirit of the Law to: (i) serve as proof that the creator created the objects described herein and expressed them in physical form, which is this report itself; (ii) unequivocally indicate its owner / holder and authors / inventor(s); (iii) inform third parties of the existence of the creations and the aforementioned industrial secret, the content for which intellectual property protection is or will be requested under the terms of the Law, including patent protection, and the date of its filing, from which it will have priority rights and the term of validity of the patent exclusivity may begin, if applicable;and (iv) assist in the technological and economic development of the Country, from the disclosure of the creation, if this occurs, and the authorization of the use of the secret solely and exceptionally for the purposes of studies and / or development of new improvements, thereby avoiding parallel reinvestment by third parties in the development of the same asset.

[0144] It is hereby warned that any commercial use requires authorization from the authors or the owner / holder, and that unauthorized use will result in penalties as provided by law. In this context, given the extensive detail with which the creation, concept, and examples have been revealed by the applicant, those skilled in the art may, without much effort, consider other ways of realizing the present creation and / or invention in ways not identical to those merely exemplified above. However, such ways are or may be considered as falling within the scope of one or more of the appended claims.

Claims

Premix for protection against infrared radiation characterized by comprising rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof. Premix according to claim 1 characterized in that it comprises up to 80% by weight of rock nanoparticles. Premix according to claim 1 characterized in that said rock nanoparticles are composed of basaltic rock. Premix according to claim 1 characterized by said rock nanoparticles comprising a particle size distribution profile being: d10: between 130 and 155 nm; d50: between 400 and 520 nm; and d90: between 5000 and 8000 nm. Composition for protection against infrared radiation characterized by comprising one or more excipients and rock nanoparticles, wherein said nanoparticles are composed of basaltic rock, plutonic rock or combinations thereof. Composition according to claim 5 characterized in that it comprises up to 10% by weight of rock nanoparticles. Composition according to claim 5 characterized by said rock nanoparticles comprising a particle size distribution profile being: d10: between 130 and 155 nm; d50: between 400 and 520 nm; and d90: between 5000 and 8000 nm. A method for blocking infrared radiation characterized by comprising at least one step of applying rock nanoparticles to a surface, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof. The use of rock nanoparticles is characterized by being for the manufacture of a composition to block infrared radiation, wherein said nanoparticles are composed of basaltic rock, plutonic rock, or combinations thereof. Use of rock nanoparticles according to claim 9, characterized in that said rock nanoparticles are composed of basaltic rock.

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