Overview of Safety Assessment and Toxicological Screening of Dermal Formulations

Parasuraman, Subramani; Balamurugan, Subramani; Vanishya, Raipan

doi:10.5005/jp-journals-10082-02258

Cited by 6 publications

(3 citation statements)

References 38 publications

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“…The mechanism of skin irritation involves a non-immune mediated inflammatory response characterised by visible effects such as erythema and oedema. The assessment of dermal irritation involves the administration of a single or repeated dose of the test substance, and the extent of irritation (no reaction, slight, moderate, or severe) is determined [85]. In contrast, skin corrosion assesses the irreversible skin damage of a substance, with symptoms such as ulcers, bleeding, and tissue necrosis [86].…”

Section: Dermal and Eye Irritation/corrosionmentioning

confidence: 99%

Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

Manful,

Ahmed,

Barry-Ryan

2024

Cosmetics

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Consumer preferences, safety, and sustainability aspects of conventional cosmetic ingredients have contributed to an increase in the demand for natural cosmetic ingredients and products. Naturally derived active cosmetic agents and excipients may come into contact with various naturally occurring and synthetic contaminants throughout the supply chain, and substantiating their safety is essential. This review examines the safety and legislative requirements applicable to natural cosmetic ingredients in the European Union (EU). Cosmetic safety requirements include technical data based on the ingredient profile, presence of hazards and the risks associated with the intended conditions of use. The hazard analysis includes screening for microbial contaminants such as aerobic mesophilic bacteria, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans; chemical contaminants such as lead, cadmium, arsenic, and mercury; and naturally occurring toxins, such as allergens. The toxicological assessment considers both local effects (such as skin sensitisation, eye/skin irritation, and photo-induced effects) and systemic effects (including acute dermal toxicity, sub-acute and sub-chronic toxicity, mutagenicity and carcinogenicity, reproductive toxicity, and toxicokinetics). The EU legislative requirements prohibit the use of animal-based tests for the toxicological evaluation of cosmetic ingredients, paving the way for alternatives termed as New Approach Methodologies (NAMs). The validation of NAMs is critical for their wider usage, and despite advancements, few have been validated, particularly for systemic toxicity testing. The use of NAMs in evaluating the safety of complex natural cosmetic ingredients is further examined.

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Section: Dermal and Eye Irritation/corrosionmentioning

confidence: 99%

Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

Manful,

Ahmed,

Barry-Ryan

2024

Cosmetics

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“…Although reuterin and several bacteriocins are produced by GRAS bacteria, they still need to meet specific safety requirements to be legally approved and used on a routine basis for different food, medical and veterinary applications. Toxicity data are necessary to determine the physiological, biochemical, and toxicological effect of a test compound and predict its safe doses 19 . We recently reviewed the toxicity and safety of bacteriocins 20 and observed a lack of studies on the issue.…”

Section: Introductionmentioning

confidence: 99%

In vitro assessment of skin sensitization, irritability and toxicity of bacteriocins and reuterin for possible topical applications

Soltani

Boutin

Couture

et al. 2022

Sci Rep

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Bacteriocins and reuterin are promising antimicrobials for application in food, veterinary, and medical sectors. In the light of their high potential for application in hand sanitizer, we investigated the skin toxicity of reuterin, microcin J25, pediocin PA-1, bactofencin A, and nisin Z in vitro using neutral red and LDH release assays on NHEK cells. We determined their skin sensitization potential using the human cell line activation test (h-CLAT). Their skin irritation potential was measured on human epidermal model EpiDerm™. We showed that the viability and membrane integrity of NHEK cells remained unaltered after exposure to bacteriocins and reuterin at concentrations up to 400 µg/mL and 80 mg/mL, respectively. Furthermore, microcin J25 and reuterin showed no skin sensitization at concentrations up to 100 µg/mL and 40 mg/mL, respectively, while pediocin PA-1, bactofencin A, and nisin Z caused sensitization at concentrations higher than 100 µg/mL. Tissue viability was unaffected in presence of bacteriocins and reuterin at concentrations up to 200 µg/mL and 40 mg/mL, respectively, which was confirmed by measuring cytokine IL-1α and IL-8 levels and by histological analysis. In conclusion, the current study provides scientific evidence that some bacteriocins and reuterin, could be safely applied topically as sanitizers at recommended concentrations.

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“…Glycosides, linoleic acid, flavanoids, etc. [2] were found in high concentrations during chemical analysis of the plants. It's clear the plant offers therapeutic promise for a variety of diseases in which free radicals have been implicated as a causative component.…”

Section: Introductionmentioning

confidence: 99%

Perform skin irritation study of the developed formulation

2020

NATURAL VOLATILES &Amp; ESSENTIAL OILS

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The goal of this study was to assess the likelihood of Acute Dermal Irritation due to Mastilep gel using OECD criteria. Substances and Techniques: To combat mastitis in ruminants, a new herbal ointment called Mastilep gel has been created for topical use to the udder. It is the suggested method for collecting scientifically solid data on the corrosivity/irritancy of a novel chemical via a series of sequential tests. There were three female rabbits utilized in the experiment. Every specimen was its own control. The degree of irritation or corrosion after using Mastilep gel was measured and recorded. The use of Mastilep gel did not result in any noticeable skin lesions or erythema. Mastilep gel was shown to have no irritating properties, according to the findings. In summary, MASTILEP gel may be used without worry. As Butea monosperma extract cream and gel showed just a little irritating characteristic, they may be safely utilized as topical preparations to treat different skin conditions or as topical cosmetics.

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Overview of Safety Assessment and Toxicological Screening of Dermal Formulations

Cited by 6 publications

References 38 publications

Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

In vitro assessment of skin sensitization, irritability and toxicity of bacteriocins and reuterin for possible topical applications

Perform skin irritation study of the developed formulation

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