In the case of in vivo carcinogenicity bioassays, a justification for not including long-term studies could be based around issues such as: the expected pattern of use (identify possible low exposure); • results of mutagenicity studies; • lack of similarity to other molecules with known carcinogenic activity; • low persistence in the skin; • low in vivo absorption; • lack of photosensitisation or phototoxic potential; • proven photostability; • lack of possible adverse effects on the skin (change to epidermis/dermis); • length of submitted repeat dose toxicity studies. • Related studies studies that are not currently referenced in EC guidelines may be useful in supporting particular applications. Reference to these studies is included only as a guide. They will not be relevant in all cases, nor should they be seen as a complete list of relevant studies. The following studies may be useful in providing information on the potential of a substance to cause tumours in people: Studies using a transgenic mouse model to test exposure to the substance (the transgenic mouse • is heterozygous for the p53 suppressor gene and tumours develop in a relatively short time frame (6 months) in this strain of mouse); In vitro human dermal cell cultures exposed to the substance; • In vitro human dermal tumour cell cultures exposed to the substance. • The following references may be useful in justifying the use of ingredients with a potential for skin corrosion/irritation: Non-animal testing strategies for assessment of the skin corrosion and skin irritation potential • of ingredients and finished products; M K Robinson et al; Food and Chemical Toxicology, 40(5), pp 573-592, 2002. OECD/OCDE, Draft TG431, March 2002, OECD Guidelines for the testing of chemicals; in vitro • skin corrosion: human skin model test. Chemistry requirements In addition to the requirements stated in Chapter 4B, , sponsors should provide data to establish the UV absorption range of the substance together with data addressing the potential for physical interaction with other commonly used sunscreening agents. New excipients in sunscreens Where a sunscreen contains an excipient ingredient which is not in any product currently included in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia, the excipient must be cleared for use by the TGA. The following information is required:
In the case of in vivo carcinogenicity bioassays, a justification for not including long-term studies could be based around issues such as: • the expected pattern of use (identify possible low exposure); • results of mutagenicity studies; • lack of similarity to other molecules with known carcinogenic activity; • low persistence in the skin; • low in vivo absorption; • lack of photosensitisation or phototoxic potential; • proven photostability; • lack of possible adverse effects on the skin (change to epidermis/dermis); • length of submitted repeat dose toxicity studies. Related studies studies that are not currently referenced in EC guidelines may be useful in supporting particular applications. Reference to these studies is included only as a guide. They will not be relevant in all cases, nor should they be seen as a complete list of relevant studies. The following studies may be useful in providing information on the potential of a substance to cause tumours in people: • Studies using a transgenic mouse model to test exposure to the substance (the transgenic mouse is heterozygous for the p53 suppressor gene and tumours develop in a relatively short time frame (6 months) in this strain of mouse); • In vitro human dermal cell cultures exposed to the substance; • In vitro human dermal tumour cell cultures exposed to the substance. The following references may be useful in justifying the use of ingredients with a potential for skin corrosion/irritation: • Non-animal testing strategies for assessment of the skin corrosion and skin irritation potential of ingredients and finished products; M K Robinson et al; Food and Chemical Toxicology, 40(5), pp 573-592, 2002. • OECD/OCDE, Draft TG431, March 2002, OECD Guidelines for the testing of chemicals; in vitro skin corrosion: human skin model test. Chemistry requirements In addition to the requirements stated in Chapter 4B, , sponsors should provide data to establish the UV absorption range of the substance together with data addressing the potential for physical interaction with other commonly used sunscreening agents. New excipients in sunscreens Where a sunscreen contains an excipient ingredient which is not in any product currently included in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia, the excipient must be cleared for use by the TGA. The following information is required:
otc-argom-121011.docx