Primary Irritation Index Research Articles

Safety assessment of female sexual hygiene product containing cannabidiol in new zealand white rabbit and clinical trial

Cannabis is an herb known for its significant pharmacological effects. This study evaluated the safety of a female sexual hygiene product containing cannabidiol on the skin of experimental animals and humans. Irritation symptoms were tested using three female New Zealand white rabbits. In human trials, irritation and sensitivity symptoms were assessed in 30 healthy female volunteers. The results from the animal study indicated that body weight and clinical symptoms remained normal, with only slight irritation noted in the primary irritation index of the skin (PII = 0.6). In human trials, transepidermal water loss was observed during the induction phase but decreased over time. No abnormalities were found during the induction phase; however, irritation occurred during the challenge phase, which resolved after 8 h. It was concluded that the rinse-off product caused slight irritation when applied for more than 4 h in animals and 24 h in humans, which differs from its intended use of immediate rinse-off, where no irritation was observed.

ASSESSMENT OF DERMAL IRRITATION OF LAO NHA QUE COCONUT OIL IN EXPERIMENTAL ANIMALS

Lao Nha Que virgin coconut oil (LNQ VCO) is a natural product inteneded to treat some skin diseases such as burns, atopic dermatitis, and xerosis.... To provide information on its local irritation, this study was carried out to evaluate the dermal irritation of LNQ VCO. 0.5 ml of VCO was applied on the skin in one side of the spine while 0.5 ml of distilled water was applied on the other side. After 4-hour exposure period, the residual LNQ VCO was removed and the skin reactions for erythema and oedema was described and scored at 1 hour, 24 hours, 48 hours and 72 hours after removing the patches. The results showed that the erythema appeard on the LNQ VCO-applied skin in two out of three rabbits and recovered up to 72h. The primary irritation index was calculated to catogorize the skin irritation of LNQ VCO. The primary irritation index of LNQ VCO was 0.78. Thus, LNQ VCO might cause slight irritation on the rabbit’s skin.

A Dermatological Safety Test of a Face Serum Formulation Derived from Honey and Propolis of Stingless Bee from East Kalimantan

Skincare, which is a type of cosmetics, is an essential component in the process of maintaining and caring for the skin. It is known that the skin quickly absorbs the tiny molecular structure of serum. Stingless bees, widespread in East Kalimantan and Indonesia, benefit the skin's health by producing honey and propolis. This research aims to demonstrate that a face serum derived from honey and propolis of stingless bees from East Kalimantan is safe for use on the skin using dermatological standards. Here we will see whether there are allergic reactions and irritation from using facial serum. Using the Repeated Open Application Test (ROPT) technique, 20 volunteers were subjected to applying a face serum containing honey and stingless bee propolis. The serum was given to the upper arm twice daily for seven days. As part of the test, allergic reactions were evaluated using the system developed by the International Contact Dermatitis Research Group (ICDRG), and irritating reactions were evaluated using the Primary Irritation Index (PII). The results showed that on the first day, four of the volunteers reported moderate irritation reactions. Consequently, they scored 0.7, indicating they suffered minor irritation. On the other hand, the reactions of the remaining 16 volunteers were typical. Twenty participants had normal skin from the second treatment until the seventh day. The overall findings show that the facial serum based on honey and kelulut propolis from stingless bees from East Kalimantan showed a mild irritation reaction at the beginning of use and was safe to use in subsequent uses.

Stability and Safety Analysis of Statin-Loaded Nano-films for the Treatment of Diabetic Wound

Diabetes mellitus (DM) is a metabolic disease that delays the regular stages of the wound's healing process due to delayed inflammatory stages. Due to foot pressure points, chronic foot wounds are ultimately considered the primary cause of lower leg amputation. Diabetic patients have vascular dysfunction and neuropathy, leading to inadequate oxygen supply to the wound area. Statins have a crucial role in the regulation of angiogenesis that could increase vascular endothelial growth factor (VEGF) synthesis. By offering a localized treatment approach while minimizing systemic side effects associated with oral medication, this study aimed to develop statin-loaded nanofilms to determine their stability and safety among healthy individuals as a potential procedure for diabetic wound healing. Simvastatin (SIM) loaded nanofilms formulations (F1-F10) were prepared using the solvent casting method. The formulation was optimized based on tests such as physical appearance, tensile strength, microscopic photographs, morphology, and drug content uniformity. ICH guidelines were followed to determine various parameters (physical appearances, tensile strength, microscopic photographs, morphology, and drug content uniformity) for six-month stability study at three different storage conditions. Safety analysis of the nanofilms was performed on healthy human skin using the Draize skin irritation test. Results showed F7 formulation was considered an optimized formulation as well as stable through the storage period at 4 ± 2°C, 25 ± 2°C, and 40 ± 2 °C. Furthermore, Primary Irritation Index results (PII was 0 showed no irritation in case and control groups) indicate its safety and biocompatibility to skin. Thus, the optimized statin-loaded nanofilm is stable, safe, and non-toxic, which may be used as a potential diabetic wound healing agent.

THE EFFECT OF VARIATION CONCENTRATION OF TETRAHYDROHEXAGAMAVUNON-5 (THHGV-5) IN EMULGEL PREPARATION ON ACUTE DERMAL IRRITATION EFFECT AND SUN PROTECTING FACTOR (SPF) VALUE

Objective: A tropical nation experiences intense daytime solar radiation. The likelihood that this condition will result in skin conditions like skin cancer may increase. The skin can be protected as one strategy for coping with this poor potency. Applying various cosmetic products to the skin can provide protection. Due to the antioxidant activity of certain components, various active ingredient types are used in the formulation of those products. A chemical that was created from the structure of curcumin is one of the examples. This substance is referred to as a curcumin analog. THHGV-5 is an analog of curcumin that has strong antioxidant properties. The purpose of this investigation is to ascertain how different Tetrahydropentagamavunon-5 (THHGV-5) concentrations affect the emulgel's sun-protecting factor (SPF) value and irritancy effect. Methods: The three different concentrations of THHGV-5 emulgel are 1.50%, 1.75%, and 2.00%. Then, tests are conducted on the physical qualities (organoleptic, pH, adhesion, dispersiility, and viscosity). The UV spectrophotometric method was used to determine the SPF value of THHGV-5 emulgel in vitro. Regression analysis was used to examine the SPF values from measurements. The acute dermal irritation method was used to measure the Primary Irritation Index (PII) in real-time. The Indonesian Food and Drug Administration's In vivo Non-Clinical Toxicity Test Guidelines are followed by this procedure. PII results were analyzed with Kruskal-Wallis statistical analysis with a 95% confidence level. Results: SPF and PII values will rise as a result of increasing the THHGV-5 content in the formulae. The concentration of THHGV-5 (1.50%, 1.75%, and 2.00%) causes the increase of the SPF values of the formulas (5.76±1.10, 13.03±1.39, and 15.77±0.22) by moderate, maximum, and ultra protection. PII values obtained are significantly different, with a significance level of ≤ 0.05. Conclusion: According to the study's findings, emulgel formulas with higher THHGV-5 concentrations would have higher SPF values and irritant effects. Since a tropical country's SPF recommendation is 15, THHGV-5 with a 2.00% concentration will be able to provide enough protection. However, a study of three different THHGV-5 concentrations (1.50%, 1,75%, and 2.00%) revealed that none of the formulae were skin-safe since they can irritate the skin.

Optimisation of seed oil and powder of Momordica charantia in the formulation of body scrub cream

Background: Momordica charantia seed oil and powder are potential ingredients for a body scrub. The seeds contain fatty acids to moisturise the skin, and the mineral content to remove dead skin cells and nourish the skin. Objective: To determine the optimal efficiency of Momordica charantia seed oil and powder on body scrub cream produce. Methods: The body scrub used W/O (water-in-Oil) cream base. Simplex Lattice Design was used to determine five formulas. The irritation test with the Draize Skin Test method was carried out on rats (n = three, in each formula), and the Primary Dermal Irritation Index (PDII) was calculated. Informed consent from the female participants has been obtained for the hedonic test. Results: The body scrub cream produced appropriate organoleptic, was not irritating, and was stable after centrifugation and cycling test. The optimum formula contained five grams of oil and one gram of powder with a pH of 5.21; viscosity of 205.33 dPa.s; spreading of 6.12cm; adhesion time of 19.86 seconds; rate of washing of 20.60 seconds; a colour value of 4.04; scent value of 2.90; and texture value of 2.98. Conclusion: The optimised body scrub cream yielded a good formula which can be developed as a body scrub preparation.

Safety evaluation and effects of cascara pulp Gayo Arabica coffee cream as anti-photoaging in animal model.

Prolonged sunlight and ultraviolet (UV) exposure causes premature skin aging called photoaging and coffee-derived topical antioxidants may help to reduce this process. Since a significant amount of antioxidant-rich cascara pulp are wasted in coffee processing, this study aimed to evaluate the safety of cascara extract cream of Gayo Arabica coffee pulp (CECGACP) as anti-photoaging in male Wistar rats (Rattus norvegicus) by assessing the skin primary irritation index (PII), skin macroscopic changes and the level of tumor necrosis factor-alpha (TNF-α). Twenty-five rats were randomly divided into five different groups: negative control (base cream only), positive control containing L-ascorbic acid 3%, and three treatment groups treated with cream containing 5%, 7.5% and 10% of CECGACP. The CECGACP was extracted, formulated into cream as a topical treatment and applied on the backs of the rats two times a day, once before the UV exposure and four hours after the exposure. After four weeks, the skins were macroscopically examined, and the TNF-α levels were measured. The PII was assessed after applying the cream 24 hours before UX exposure. Our data suggested that CECGACP was considered safe because there were no erythema and edema formation on the skin of the rats with PII score of 0 (classified as no irritation or negligible). After UV exposure, all rats had visible wrinkles and erythema on the skin in particular in the first week. After administration of CECGACP, both wrinkles and erythema were decreased. The levels of TNF-α varied from 0.15±0.02 ng/mL in the negative control and CECGACP 7.5% rat groups to 0.19±0.03 in the positive control group; however, there was no significant difference among all the groups. Our study suggests that CECGACP is safe to use in Wistar rats and able to reduce the erythema and edema due to UV exposure. However, the application of CECGACP does not provide a significant reduction of TNF-α levels.

The Use of an Ambroxol Solution to Assess Acute Dermal Irritation on Rabbit Skin

Ambroxol can overcome infections due to the presence of biofilms in the body by interfering with the formation of sticky biofilms and reducing biofilm production, so it has the potential to be used in topical preparations for the treatment of infections. This study aimed to measure the irritating effect on the skin of rabbits resulting from the ambroxol solution to assess the safety of the ambroxol solution. The methods refers to BPOM 2020, namely by dabbing 0.5 ml of ambroxol solution on the back skin of rabbits, then covering it with gauze and non-irritant plasters, after 4 hours of cleaning of residues is then observed at 1 , 24, 48 and 72 hours to see whether or not there was an effect of erythema and edema arising from the influence of the experiment, and at the end of the investigation, a histopathological test was carried out. The results of the research are Macroscopically the ambroxol solution did not show any erythema and edema, so the primary irritation index score was obtained for all test solutions with a score of 0. In contrast, in the microscopic irritation test, the score for erythema was 4 and for edema was 3. . From this research, it can be concluded that the ambroxol solution non-irritating to the skin.
 
 KEYWORDS: Biofilm, ambroxol solutions, acute irritation test.
 

Activity and Safety of Cinchonine Nanostructured Lipid Carriers as a Hair Growth Stimulant in Mice Model of Androgenetic Alopecia

Androgenetic alopecia (AA) is a hair growth disorder characterized by hair loss and miniaturization of the size of follicles and dermal papillae. Cinchonine is a quinoline alkaloid that can increase VEGF production and potential as a hair growth stimulant. This study aimed to determine the morphology, penetration (in vitro), as well as safety and activity of cinchonine nanostructured lipid carriers (CN-NLC) serum as a hair growth stimulant. Preparation of CN-NLC serum using a combination of micro-emulsification and ultra-sonification methods, characterization of CN-NLC serum included morphology and closed hair follicle diffusion methods. Dermal and eye irritation test using New Zealand rabbit strain with primary irritation index parameters. Hair growth stimulant activity test using Swiss Webster mice strain, induced with the hormone testosterone. Observations were performed at 7, 14, and 21 days with hair length and histology parameters. CN-NLC serum morphology is a spherical shape with size ±500 nm, diffusion of serum CN-NLC (open hair follicles) of 23.92±0.84%; (close hair follicles) of 11.37±2.29%; and CN solution of 6.00±0.72%. CN-NLC serum are non-irritant with a primary irritation index of 0.0. Activity tests showed hair length on days 7; 14 and 21 were increased by 20.24-23.74%; 33.47-36.43%, and 39.30-39.97% (P≤0.05). Histological data showed an increase in the number and size of both dermal papillae and hair follicles compared to the control group. CN-NLC serum can improve the penetration of CN into hair follicles. CN-NLC serum is safe and effective as a hair growth stimulant in the treatment of AA.

Exploring the Potent Combination of Quercetin-Boronic Acid, Epalrestat, and Urea Containing Nanoethosomal Keratolytic Gel for the Treatment of Diabetic Neuropathic Pain: In Vitro and In Vivo Studies.

Transdermal penetration of therapeutic moieties from topical dosage forms always remains a challenge due to the presence of permeation impeding keratin which should be addressed. The purpose of the study was to formulate quercetin and 4-formyl phenyl boronic acid (QB complex) used for the preparation of nanoethosomal keratolytic gel (EF3-G). The QB complex was confirmed by Fourier transform infrared spectroscopy while skin permeation, viscosity, and epalrestat entrapment efficiency were used for the optimization of nanoethosomal gel. The keratolytic effect of the proposed nanoethosomal gel with urea (QB + EPL + U) was calculated in rat and snake skin. The spherical shape of nanoethosomes was confirmed by scanning electron microscopy. According to the findings of stability studies, viscosity decreases as temperature increases, proving their thermal stability. The negative charge of optimized EF3 with 0.7 PDI proved narrow particle size distribution with homogeneity. Optimized EF3 showed two folds increase of epalrestat permeation in highly keratinized snake skin as compared to rats' skin after 24 h. Antioxidant behaviors of EF3 (QB) > QB complex > quercetin > ascorbic acid proved reduction of oxidative stress in DPPH reduction analysis. Interestingly, the hot plate and cold allodynia test in the diabetic neuropathic rat model reduced 3-fold pain as compared to the diabetic control group which was further confirmed by in vivo biochemical studies even after the eight week. Conclusively, ureal keratolysis, primary dermal irritation index reduction, and improved loading of epalrestat render the nanoethosomal gel (EF3-G) ideal for the treatment of diabetic neuropathic pain.

PHYSICAL STABILITY TEST HAIR TONIC COMBINATION Cinnamon (Cinnamomum burmanii) ESSENTIAL OIL AND VCO (VIRGIN COCONUT OIL) WITH CYCLING TEST METHOD AND IRRITATION TEST ON THE RABBIT

Cinnamon (Cinnamomum burmanii) and VCO (Virgin Coconut Oil) essential oils contain cinnamaldehyde and lauric acid which have potential for hair growth, they can affect the physical stability of hair tonic preparations. This study aims to determine the physical stability and determine the effect of the irritation effect on hair tonic preparations of a combination of cinnamon essential oil and VCO. Cinnamon essential oil hair tonic preparations were made with a concentration of 1% (F1), 3% (F2), and 5% (F3) and then tested for physical characteristics including organoleptic tests, homogeneity, pH, density test, and viscosity. Evaluation of physical stability was carried out using the cycling test method. Data were statistically analyzed using One Way Anova. The results of the irritation test were analyzed descriptively using the primary irritation index obtained from the appearance of erythema and edema on the rabbit's skin. Observation of the physical stability test on organoleptic and homogeneity showed that formula I had a cloudy white color, a characteristic cinnamon aroma, a slightly thick liquid, and was homogeneous; formula 2 and 3 has a clear color, characteristic of cinnamon aroma, slightly viscous and homogeneous liquid; stable pH in formula 2; stable density in formulas 1, 2 and 3; and stable viscosity in formulas 2 and 3. The results of the hair tonic irritation test showed that the primary irritation index for F1, F2, and F3 was 0.0; 0.3; 0.3 and it can be concluded that F2 and F3 can irritate with very mild categories.

Design of an Ante-enhancer with an Azone-Mimic Structure using Ionic Liquid.

Laurocapram (Azone) was broadly examined as a representative enhancer of skin penetration in the 1980s. However, it was not approved for treatment because it caused skin irritation following its penetration into the epidermis through the stratum corneum. In the present study, a so-called ante-enhancer with an Azone-mimic structure was designed based on an ante-drug with negligible systemic toxic effects following its permeation through the skin. The ante-enhancer was designed using ionic liquid technology: an ionic liquid-type ante-enhancer (IL-Azone) with an Azone-mimic structure was prepared from ε-caprolactam and myristic acid as cationic and anionic substances, respectively. The enhancing effects of IL-Azone on the permeation by the following model drugs through pig skin were examined: isosorbide 5-mononitrate (ISMN), antipyrine (ANP), and fluorescein isothiocyanate dextran (FD-4). Skin irritation by IL-Azone was assessed using the Draize method. The primary irritation index (P.I.I.) of IL-Azone by the Draize method was markedly lower than that of Azone (6.9). Although the ability of IL-Azone to enhance skin penetration was not as high as Azone, IL-Azone moderately increased skin permeation by the model compounds tested (ISMN: 4.7 fold, ANP: 4.5 fold, FD-4: 4.0 fold). These results suggest the usefulness of designing a skin penetration enhancer using ionic liquid technology. Further trials on the ionic liquid design with an Azone-mimic structure using other cations and anions may lead to the development of better ante-enhancers.

Antimicrobial ability and free-irritation effect of neem-based lotion cosmeceutical for skin care

Neem (Azadirachta indica) is well-known as a medical plant to treat some diseases. The antibacterial activity and primary skin irritation test were evaluated by using ethanolic neem extract. The main objective of the study is to determine the effectiveness of the neem-based lotions against Staphylococcus aureus sp and Pseudomonas aeruginosa sp. A series of lotions were prepared by adding different formulations of pure neem extract, coconut oil (CO) and aloe vera. The comparison was made with base lotion and commercial neem lotion. The lotion with diluted neem in CO and aloe vera had the best result against Staphylococcus aureus sp. and Pseudomonas aeruginosa sp. with the inhibition diameter zone of 19.3 mm and 9.6 mm, respectively. The commercial neem lotion with aloe vera displayed an inhibition diameter zone of 11.1 mm and 14.1 mm against Staphylococcus aureus sp. and Pseudomonas aeruginosa sp, respectively. Furthermore, this lotion was examined in a primary skin irritation test to ensure the possible effect on the skin. Erythema and oedema analyses exhibited a 0 irritation score means no skin irritation was observed on the both right and left back of the rabbit after 72 hrs. Hence, the primary irritation index of the lotion with diluted neem oil lotion and aloe vera was 0 and falls in the standard category of ‘negligible’. The study confirmed that neem lotion has the potential an antimicrobial agent for skin disease treatment and does not cause irritation effect to the skin.

ANTIPSORIATIC ACTIVITY OF HYDROGEL CONTAINING NANOSTRUCTURED LIPID CARRIER (NLC) ENTRAPPED WITH TRIAMCINOLONE ACETONIDE

Objective: The aim of present study was to prepare triamcinolone acetonide (TA) loaded NLCs hydrogel for antipsoriatic activity. Methods: A Nanostructured lipid carrier (NLCs) was prepared by using solvent diffusion and high pressure homogenization methods. NLCs dispersion was characterized by particle size, zeta potential, scanning electron microscopy (SEM), differential scanning calorimetry, and an in vitro release study. Optimized NLC incorporated into the hydrogel and characterized for rheological properties, drug content, in vitro drug release, stability study, skin irritation and antipsoriatic activity for optimized batch of hydrogel. Results: Optimized NLCs loaded with TA were exhibited spherical shape with particle size 286±0.07 nm, polydispersity index 0.317, zeta potential-21.91±0.05mV and entrapment efficiency 86.19±0.06% respectively. The drug release of optimized batch was 8.34 % and 88.84±0.08% at 1h and 8h respectively. The release kinetics of the optimized NLCs best fitted the peppas-korsmeyer model. The results of NLC hydrogel formulations were spreadability 27.4±0.06-11.76±0.07 g. cm2/sec, drug content 65.60±0.05%-74.50±0.02%, in vitro drug release 87.52±0.04%, primary irritation index was 0.0752, it indicates barely perceptible irritation. Histopathological studies showed that, in psoriasis-induced animal treated with TA loaded NLC hydrogel, marked reduction in thickness of epidermis, as compared to conventional gel formulation. It shows the increase % orthokeratosis 88.69% and % drug activity 54.23% than the marketed formulation. Conclusion: The present results demonstrated that hydrogel based NLC shows the better and effective drug delivery for the management of psoriasis.

Irritation Test of Bawang Dayak (Eleutherine Bulbosa (Mill.) Urb.) Loose Powder for Acne Vulgaris

Several studies revealed that the ethanolic extract, cream, and loose powder of Bawang Dayak bulbs (Eleutherine bulbosa (Mill.) Urb.) are effective in inhibiting the growth of different acne-causing bacteria, including S. aureus, S. epidermidis, and P. acne. Several product series have also been developed using the plant for the treatment of acne-prone skin. Therefore, this study aims to carry out a primary irritation test of E. bulbosa loose powder using the patch test method on rabbits and humans to determine its safety before it is marketed. The results showed that the primary irritation index of E.bulbosa loose powder on rabbits was 0.125, which was classified in the negligible category, and there were no signs of erythema or edema in humans. This indicates that it does not cause irritation and has the potential to be developed into anti-acne products.

Evaluation of skin-irritancy potential of a skin ointment containing the essential oil of ocimum sanctum l (Basil/Thulasi) leaves in Wistar albino rats

Skin irritant potential of a skin ointment containing 4% essential oil extracted from the Ocimum sanctum L. (Basil/Thulassi) leaves was evaluated on the hair clipped skin of female Wistar albino rats. The calculated Primary Irritation Index was ‘0” and it falls under the category of “negligible irritant.

Preclinical Assessment of Aceclofenac Transdermal Patch by Freund’s Complete Adjuvant-induced Arthritis in Rats

>The hydroxypropyl methylcellulose (HPMC) based transdermal patches of aceclofenac were prepared. On the basis of in-vitro potential, the formulation was additionally chosen and assessed for their in-vivo anti-arthritic activity and acute skin irritation tests using the primary skin irritation (draize) test and freund’s complete adjuvant (FCA) caused arthritis technique. Furthermore, stability studies were conducted in compliance with ICH standards. The studied compositions had no irritant potential, and no edema production was ever noticed. All of the formulations had a zero irritation score (primary skin irritation index), indicating their safety and acceptability for transdermal administration. The stability investigations confirmed the produced patch’s stability, and the in-vivo analysis showed a considerable decrease in the volume of irritated paws compared to the marketed formulation. The created transdermal patches may serve as a platform for the delivery of medication for the treatment of arthritis

Wound-Healing and Antibacterial Activity of the Quercetin–4-Formyl Phenyl Boronic Acid Complex against Bacterial Pathogens of Diabetic Foot Ulcer

Complications of diabetic foot can be prevented using a naturally occurring, efficient, and newly synthesized antimicrobial agent. The purpose of the study was to improve wound healing and antibacterial effects of quercetin and its esterified complex with 4-formyl phenyl boronic acid (4FPBA–Q) compared with phenytoin. The formation of the 4FPBA–Q complex was confirmed by thin-layer chromatography (TLC), Fourier transform infrared (FTIR) spectroscopy, and mass spectrometry (MS). The prepared 4FPBA–Q complex was used against Gram-positive bacteria along with Gram-negative bacteria, and more than 2-fold decrease in minimum inhibitory concentrations (MIC) was observed compared to pure quercetin. Scanning electron microscopic images of Pseudomonas aeruginosa and Staphylococcus aureus showed their complete destruction after incubation with the 4FPBA–Q complex even after 3 h. Interestingly, wound-healing properties of the 4FPBA–Q complex in infected diabetic rats increased from 64 to 99% as compared to phenytoin, which were increased from those of noninfected diabetic rats. Furthermore, histopathological evaluations showed significantly enhanced wound healing, re-epithelialization, fibroblasts, and angiogenesis in wounds of diabetic rats after 10 days. Conclusively, reduction in the primary irritation index (PDII) and improved antibacterial and wound-healing properties render the 4FPBA–Q complex ideal for diabetic foot ulcer treatment.

A Study on the Skin Irritation Toxicity Test of Processed Sulfur in New Zealand White Rabbit.

ObjectivesThis study was performed to evaluate the skin irritation toxicity of processed sulfur.MethodsAll experiments were conducted at Medvill (Korea), an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate skin irritation toxicity of processed sulfur, we divided the back of six rabbits into two control sites and two test sites. One of each of the two control and test sites was then designated abraded sites and intact sites. In test sites, 0.5 g of processed sulfur was applied to the back of the rabbit for 24 hours, and in control sites, 0.5 g of sterile distilled water was applied in the same way. We observed and evaluated mortality, weight, general symptoms, and skin irritation toxicity. This study was conducted with the approval of the Animal Ethics Committee (Approval number IAC2020-1549).ResultsIn all experiments, no dead animals were observed. In all cases, skin coloration was observed at 24 hours after processed sulfur administration. This coloration lasted up to 48 hours and is believed to be the effect of the administration of test substances. Weight measurement indicated that weight was lost 72 hours after administration in three cases, but this is considered an accidental weight change. Normal weight gain was observed in the remaining subjects. In all animals, no skin irritation toxicity was observed, and the primary irritation index (P.I.I) was calculated as 0.0 according to Draize’s evaluation method.ConclusionThe above findings suggest that it is relatively safe to apply a processed sulfur to the skin. Further research on this topic is needed to provide more specific evidence.

UJI IRITASI DAN AKTIVITAS TABIR SURYA SECARA IN VITRO MINYAK BIJI PALA DALAM SISTEM MIKROEMULSI DENGAN VARIASI TWEEN 80-ETANOL

ABSTRACTNutmeg oil contains of α-pinene that can be used as sunscreen but it is thermolable. It is necessary to form a microemulsion system for nutmeg oil. This study was to determine in vitro SPF value by and irritation index from nutmeg oil in microemulsion system with Tween 80-ethanol as surfactant and cosurfactant. The system were made with 6.4 % of nutmeg oil and Tween 80-ethanol as with concentrations of 45% (F1), 50% (F2), 55% (F3). The nutmeg oil microemulsion was determined SPF value using spectrophotometer UV. The irritation test was done by the patch test method on rabbit skin with 4 groups of negative control, F1, F2, and F3. The skin was observed at 24, 48 and 72 hours. Quantitative data were analyzed using one way Anova while irritation test data were described descriptively. The results of the sunscreen activity on nutmeg oil microemulsion for F1, F2 and F3 were 8,9 ± 0,12; 9,2 ± 0,51; and 9,3 ± 0,32 (p > 0,05). This SPF value were categorized in maximum protection. The primary irritation index values for F1, F2 and F3 were 0,1±1; 0,3±2,5; 0,1±0; so it can be concluded that microemulsion of nutmeg oil were very mildly irritating.Keywords: irritation, microemulsion, nutmeg seed oil, sunscreen activity