Research - Safety Test

Irritation Test

There was no damage on the surface of the chicken chorioallantoic membrane (HET-CAM), and there was no irritation of blood vessels, blood clotting or melting. According to the scoring criteria, ES=0 for no eye irritation.

Irritation tests
Cell culture tests and human skin tests
Cell cultures are used to check whether a product poses a definitive hazard to normal human cells after penetration into the skin (cell mortality >50%).

Before the human test, BioTruly will conduct an internal risk evaluation of the raw materials or formulation’s ingredients to confirm that there is no risky substance in excess of the hazard components. Their pH value should be within a reasonable range so that we can conduct human test. We use the gold standard cosmeceutical evaluation method: PATCH TEST. Patches are applied directly to the surface of human skin for 24-48 hours. It is used to confirm whether the product will have a clear irritating effect on normal skin when it leave on the body for a long time.

In the future, BioTruly will continue to pay attention to more alternative testing methods. In order not to harm animals, we will use high quality and reliable models to proceed cosmetics irritation tests.

Safety Evaluation
Result of Eye irritation test
The eye irritation method of BioTruly fermented serum (ie, the original cosmetic shown in the chart) was evaluated by qualitative and quantitative methods using in vitro experiments: HET-CAM experiments and CAM-TBs.

Result of HET-CAM test
After the reaction of sample and the chicken chorioallantoic membrane, the blood vessels on the surface of the allantoic membrane were hemorrhagic, coagulated, dissolved, and graded to evaluate the intensity of eye irritation.
The judgment criteria and test methods are shown in Annex 1, and the test results are shown in Figure 1.

Before use, the surface of the chicken embryo chorioallantoic membrane was not damaged. The blood vessel was intact without damage, which met the experimental requirements.
After use, the surface of the chicken embryo allantoic membrane was not damaged. The blood vessels did not have the irritation of bleeding, coagulation, and melting.
According to the scores, BioTruly fermented serum resulted to be no eye irritation. Through HET-CAM experiment, ES=0.

Result of CAM-TBs test
After the sample reacts with the chicken embryo chorioallantoic membrane, the damaged allantoic membrane can adsorb the blue pepper. The sample eye irritation was evaluated by quantitatively measuring the amount of the mixture. The judgment criteria and test methods are shown in Annex 2. The specific test results are shown in Figure 2.

According to the negative control and positive control results, the test method and process are credible.
According to the scoring standard, the absorption of the Trypan Blue of fermented serum is less than 15 nmol. So no irritation.

Skin Model Test
The skin irritation was determined by the size of epidermal cell activity in the skin model after the sample reacted with the skin model. The specific criteria and test methods are shown in Annex 4. The specific results are shown in Figure 4.

According to the blank control, negative control, and positive control results, the test process and method are credible and correct.
According to the judgment criteria, the cell viability of BioTruly fermented serum was greater than 50%, indicating that it did not cause skin irritation.

BioTruly fermented serum are applied for patch test. Only one of the 30 volunteers had a first grade reaction when the patch was removed after 0.5 h. There was weak redness reaction occurred in the test area. The specific results are shown in Figure 5. The volunteers’ response record is shown in the appendix. According to the standard, if the number of people whose response is Level 1 less than 5 people, it results that sample did not cause negative reactions on human body and not irritation.

Heavy Metal Analysis

Heavy metals can stay on the surface of the skin, and some can even permeate into the depth of skin and kill cells. For example, the lead, mercury and other substances have long been classified as banned products because they poison the normal cells of the human body. When planting, fertilizing and irrigating natural plants, if not properly taken, may result into heavy metals restored in plants, which poses a safety risk. BioTruly not only carefully selects the source of raw materials, but also conducts random inspections and third-party inspections of finished products (refer to Chinese national standards and EU standards). BioTruly can guarantee all products from BioTruly, without any risk of heavy metals!

Analysis on Pesticide residues

Pesticide itself exists to kill animals and plants (such as weeds) and is naturally harmful to human. Therefore, in addition to carefully selecting the source of raw materials, we will also conduct random inspections from time to time to send them to third-party inspections (refer to EU standards or German standards) to do dozens of pesticide residue testing. BioTruly guarantees that there is no risk of pesticide residues in the products from BioTruly!

Hormone test

Hormones are signals in animals and plants. By transmitting these signals to the cells, it is possible to activate different responses of the cells. The hormones that have been used in cosmetics are mainly glucocorticoids and sex hormones, and they are mostly in the category that can hinder the occurrence of immune responses. For example, hormones can greatly decrease redness and stinging by suppressing the immune response. This can be understood as signaling that the cells do not release allergens, which can immediately improve the symptoms of allergic reactions, making the patients feel like themselves will be fine at once.

Why is it effective when used, but once it is stopped, the symptoms are coming back and may be more serious?
The improvement obtained with these hormones is only an illusion. Because these hormones do not have the effect to treat the skin, they only transmit some wrong signals to the cells so that the cells do not continue to secrete allergens.

The production of allergic substances is actually the way in the process of self-repair of the human body. Because of the pain and redness, the immune cells of the human body are automatically activated and go to the stimulated area to destroy the foreign matter. After completion, the fiber is finished. The cells are activated to repair the damaged area and generate more protein to fill the wound. If we have long-term resistance to the formation of allergic substances, the skin of this part will not be repaired, and it will be damaged to a certain extent. The skin of this part will be painful even if it touches the water, and basically it is impossible to use various products. At the same time, it may also cause tumors to develop, dry, sensitive, persistent redness, and the production of pigmented tumors.

Therefore, the use of hormones is prohibited in cosmetics.
The use of hormones in international medical treatment is also strictly limited. Generally speaking, the dose from doctor is just for a few days each time. Because the doctor will judge whether to stop immediately when returning from the clinic every few days, and ready to start using products that can really repair the skin.
Why the performance of BioTruly skin care products is better than most of the other conventional products? Because the core material of BioTruly is derived from a large number of small molecular nutrients obtained after fermentation of plants. They have strong penetrating properties, which can promote the cells activation and increase protein synthesis to improve the skin. It’s result is no coming from the addition of hormone.