Toxicology - Cosmetics
List* of tests performed at BioTox by Icare
tests for raw materials and cosmetic ingredients
Toxicological studies:
- Cytotoxicity in human cells
(fibroblasts, melanocytes, keratinocytes, adipocytes, endothelial cells, etc.) - Phototoxicity in Balb/c 3T3 (OECD 432)
- Skin irritation on reconstructed human epidermis
- Inflammatory potential on reconstructed human epidermis
- Apoptosis study
- In vitro eye irritation (neutral red/SIRC or diffusion/agarose gel /L929 according to Official Journal)
- Acute toxicity in mice (OECD 420)(**)**
- Skin irritation/corrosion in rabbits (OECD 404)(**)**
- Eye irritation/corrosion in rabbits (OECD 405)(**)**
- Sensitisation in guinea pigs (OECD 406)(**)**
- Pyrogenic effect in rabbits (European Pharmacopoeia)(**)**
- Subacute toxicity in rats (4 weeks) (OECD 407)(**)**
- Subchronic toxicity in rats (12 weeks) (OECD 408)(**) **
- Carcinogenesis in rats (OECD 451)(**)**
- Reproductive and developmental toxicity (OECD 415, OECD 416, OECD 414, OECD 421)(**)**
DNA damage, mutagenicity, genotoxicity:
- 5 or 6-strain Ames test (Salmonella typhimurium, Escherichia coli) (OECD 471)
- Testing for chromosomal aberrations in mammalian cells (human lymphocytes, CHO, V79, TK6) (OECD 473)
- Gene mutation test in mammalian cells (L5178Y, V79, TK6) (OECD 476, OECD 490)
- In vitro micronucleus test in mammalian cells (CHO, TK6) (OECD 487)
- COMET test (DNA damage, DNA protection) (OECD 489)
- Micronucleus test in rats (OECD 474)(**)
In vitro efficacy tests in human cells and reconstructed human epidermis:
- Cell growth
- Cell differentiation
- Synthesis (collagen, elastin) and degradation (metalloproteinases) of the extracellular matrix (ECM)
- Anti-inflammatory action (cytokines, prostaglandins)
- Chemotaxis and cell migration
- Pigmenting/depigmenting effect
- Lipolytic effect
- Wound-healing models
- Cell renewal
- Anti-ageing effect
- Study of the cytoskeleton
- Mitochondrial respiration
- Protective effect (e.g. photoprotection)
- Anti-free radical action
- Study of stress proteins
- Functionality of the stratum corneum
- Transcutaneous passage
- Qualitative and quantitative histology and immunohistology
- Bactericidal effect
- Testing for contaminants (DNA, DNase, RNase, ATP and RNA)
Adapted screenings and protocols on request
*Non-exhaustive list: for more information, click here!
**Specific studies for cosmetic ingredients
(**) Tests performed in partnership, in accordance with Good Laboratory Practices
Finished cosmetic products:
A cosmetic product is defined as “any substance or mixture intended to be brought into contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and the external genital organs) or with the teeth and the buccal mucosa, solely or principally for the purpose of cleaning them, scenting them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odours.”
(source: Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products)
A finished cosmetic product is defined as “the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype.”
(source: Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 on cosmetic products)
Cosmetic ingredients:
A cosmetic product is defined as “any substance or mixture intended to be brought into contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and the external genital organs) or with the teeth and the buccal mucosa, solely or principally for the purpose of cleaning them, scenting them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odours.”
(source: Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products)
“The concept of an ingredient or combination of ingredients is defined as a substance or a mixture of substances with specific specifications.”
(source: Official Health Bulletin No.5 of 15/06/2010 – Notice of 15 June 2010 to manufacturers or persons responsible for placing a cosmetic product on the market)