Toxicological Evaluation Of Cosmetics

Scope of evaluation

 

(1) Product and Raw Material Range
Product type: ordinary cosmetics (skin care, color makeup, cleaning, hair care, perfume, baby cosmetics, etc.), special cosmetics (spot whitening, sunscreen, hair loss prevention, acne elimination, hair dyeing, perm, hair rearing, hair loss, beauty, deodorization, etc.), imported cosmetics.
Raw material scope: New cosmetic raw materials (materials used domestically for the first time, adjusted for use purposes/safe dosage), high-risk raw materials (including heavy metals, hormones, photosensitivity, allergenicity, and cytotoxic ingredients), and resident/high exposure raw materials.
Special Scenarios: Registration/Filing of New Raw Materials, Registration of Special Cosmetics, Filing of Ordinary Cosmetics, Formula Changes, Safety Assessment, Traceability of Adverse Reactions, Market Sampling Risk Verification.

(2) Evaluation object and scenario

Evaluation objects: finished cosmetics, raw material monomers, raw material mixtures, production process related impurities, packaging migration materials.

Applicable scenarios: pre-market safety verification, identification of hazardous substances, dose-response relationship assessment, determination of safety thresholds (NOAEL/LOAEL), preparation of safety assessment reports, and regulatory compliance verification by Hainan Market Supervision Bureau.

Exposure routes: skin contact (stay/wash away), eye contact, lip contact, mucosal contact, transdermal absorption, accidental oral/inhalation

Core evaluation items

 

(1) Basic evaluation items (finished products/conventional raw materials)
acute toxicity test
Acute oral toxicity test: Determine LD50 and evaluate single oral ingestion toxicity.
Acute transdermal toxicity test: Determine LD50 and evaluate single skin contact toxicity.
Stimulating/Corrosive Test
Skin Irritation/Corrosion Test: Evaluate the risk of skin erythema, edema, and corrosion.
Acute eye irritation/corrosiveness test: sensitization test to evaluate the risk of corneal, conjunctival, and iris damage
Skin allergy test (skin sensitization): predicting the risk of delayed onset allergies.
Phototoxicity/photosensitivity test (trigger condition: containing UV absorbing components)
Skin phototoxicity test: Evaluate skin toxicity after ultraviolet irradiation (3T3 neutral red uptake method).
Skin photosensitivity test: Evaluate UV induced allergic reactions.

(2) Advanced risk projects (new raw materials/high-risk products)
Genotoxicity (mutagenicity) test (required for combination)
Chronic toxicity/carcinogenicity test (high-risk raw materials)
Carcinogenicity test: Evaluation of potential carcinogenic risks Other specialized tests
Skin absorption test: Determine the transdermal permeability coefficient (Kp) and evaluate the in vivo exposure.
Human suitability test: Products for infants/sensitive areas need to be tested to verify their actual safety for use.

(3) Special Product Additional Projects
Infant and toddler cosmetics: Strengthen the assessment of skin irritation, eye irritation, allergenicity, and reproductive development toxicity, with strict safety thresholds.
Eye/lip cosmetics: Special evaluation for increasing eye irritation, mucosal irritation, and sensitization.
Sunscreen/freckle removal and whitening cosmetics must undergo phototoxicity, photosensitivity, skin absorption, and subchronic toxicity tests.
Hair dye/perm/anti hair loss cosmetics: increase genetic toxicity, reproductive development toxicity, and long-term skin irritation assessment.
 

GB/T 16886.10 Biological evaluation of medical devices - Tests for irritation and skin sensitization

GB/T 21763 Test Method for Subchronic Oral Toxicity of Chemicals to Rodents

GB/T 27826 Test Method for Reproductive and Developmental Toxicity of Chemicals

GB/T 27827 Test Method for Acute Oral Toxicity of Chemicals

Zhejiang Gangxin Testing Technology Co., Ltd.

was established in 2011. As a national high-tech enterprise recognized by the Zhejiang Provincial Higher People's Court as a judicial authentication institution for construction engineering quality, we specialize in structural performance testing and safety assessment of construction projects, special equipment, communication towers, electromagnetic environments, large bridges, and building safety appraisal.

The company has more than 100 professional and technical personnel, over 90% of whom hold various medium and senior technical certificates. Equipped with complete testing equipment worth over RMB 10 million, our business scope covers the whole country.