Health food toxicity study
Definition of Classification | Genotoxicity ( 3 items) | Repeated Dose 28-Day Oral Toxicity Study in Rodents | Repeated Dose 90-day Oral Toxicity Study in Rodents | Prenatal Developmental Toxicity Study | Carcinogenicity Study | Reproduction Study |
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|---|---|---|---|---|---|---|---|
Category 1 | Products made from traditional food ingredients and manufactured with normal processing techniques or methods | X | X | X | X | X | X |
Category 2 | Products made from traditional food ingredients but manufactured with non-traditional processing techniques or methods | ○ | ○ | X | X | X | X |
Category 3 | Products made from non-traditional food ingredients | ○ | X | ○ | ○ | X | X |
Category 4 | Products made from non-traditional food ingredients and may have carcinogenic ingredients | ○ | X | ○ | ○ | ○ | ○ |
Toxicity/Safety study method
OECD 471-Bacterial Reverse Mutation Test
OECD 473-In Vitro Mammalian Chromosomal Aberration Test (Alternative with OECD 490)
OECD 490-In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene (Alternative with OECD 473)
OECD 474-Mammalian Erythrocyte Micronucleus Test
OECD 407-Repeated Dose 28-Day Oral Toxicity Study in Rodents
OECD 408-Repeated Dose 90-day Oral Toxicity Study in Rodents
OECD 414-Prenatal Developmental Toxicity Study
OECD ***-Carcinogenicity Study
OECD ***-Reproduction Study