Skin & Eye Safety Testing
Topical Care Range
Clinical report 1 a. – Skin safety studies
Type of study: controlled occlusive patch test
Date: 14-09-2023
Subjects: n = 54
Age: 18-74 yr
Gender: male & female (89% females)
Subject groups: participants with self-reported sensitive (56%) or normal (44%) skin, and history of allergies (28%)
Skin type: Caucasian (80%), Asian (13%), Middle Eastern (4%), Indian/Subcontinent (2%) and South Pacific/Papua (2%)
Duration: 24 hr
Dose: 1/10 dilution for wash-off products, undiluted for topicals, single spot exposure
Treatment: Samples of LE Care products (applied to inner upper right arm)
Control: distilled water (applied to inner upper left arm)
Assessments: dermatological scores for redness, thickening or bumps on the skin, or broken skin, using a clinically supervised rating scale (0-4)
Outcomes: No visual signs of any irritation to any product in any subject compared to controls, with 0.0 score for all subjects for all tested products
Clinical report 2 a. – Skin safety studies
Type of study: controlled occlusive patch test
Date: 09-10-2023
Subjects: n = 54
Age: 44-77 yr
Gender: male & female (80% females)
Subject groups: participants with self-reported sensitive skin (81%) or normal skin (19%); history of allergy (35%) or none (65%)
Skin type: Caucasian (94%), Asian (4%), Indian/Subcontinent (2%)
Duration: 24 hr
Dose: 1/10 dilution for wash-off products, undiluted for topicals, single spot exposure
Treatment: Samples of LE Care products (applied to inner upper right arm)
Control: distilled water (applied to inner upper left arm)
Assessments: dermatological scores for redness, thickening or bumps on the skin, or broken skin, using a clinically supervised rating scale (0-4)
Outcomes: There were no visual signs of any irritation to any product in any subject compared to controls, with 0.0 score for all subjects for all tested products
Scientific report 1 b. – Eye safety studies
Type of study: in vitro ocular irritation test (OECD No. 496)
Duration: 24 hrs
Dose: serial dilutions of product
Treatment: Samples of LE Care products
Assessments: microvolumes of serial dilutions are applied to a semi-permeable membrane that mimics the cornea. Any damage to the membrane after 24hrs of exposure is detected using digital scanning techniques and given a score of 0-80. Acceptable levels are <12 units.
Type of study: in vitro ocular irritation test (OECD No. 496)
Duration: 24 hrs
Dose: serial dilutions of product
Treatment: Samples of LE Care products
Assessments: microvolumes of serial dilutions are applied to a semi-permeable membrane that mimics the cornea. Any damage to the membrane after 24hrs of exposure is detected using digital scanning techniques and given a score of 0-80. Acceptable levels are <12 units.
Type of study: in vitro ocular irritation test (OECD No. 496)
Duration: 24 hrs
Dose: serial dilutions of product
Treatment: Samples of LE Care Nourishing Lotion
Assessments: microvolumes of serial dilutions are applied to a semi-permeable membrane that mimics the cornea. Any damage to the membrane after 24hrs of exposure is detected using digital scanning techniques and given a score of 0-80. Acceptable levels are <12 units.
Type of study: Colorimetric chemical analysis
Assessments: Swimprotect 2-in-1 was tested in a chemistry assay using an in-house standardized protocol using increasing concentrations of sodium hypochlorite solution (up to 4 ppm) representing levels found in most swimming pools.
The product was mixed with a substrate and allowed to react until there was a colour change, and the color was then measured using a digital meter at different sample strengths (0.004-0.05%).
Outcomes: SWIMPROTECT 2-in-1 shows a very efficient, dose-dependent effect in neutralizing dissolved chlorine (similar to up to 0.5 ml of product to 1 litre of rinse water).
