Food ingredients including food additives, color additives used in food, food contact substances are evaluated in range of safety assessment studies. Adgyl Lifesciences has tremendous experience and expertise of more than 28 years in designing and executing the safety program as per FDA Red Book/ CFSCAN/EFSA requirements. The data was successfully submitted to US FDA, MHRA, EMA and other regulatory authorities.
The following studies are offered:
Genetic Toxicology Studies
- Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
- In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
- In Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene (OECD 490)
- In Vivo Mammalian Erythrocyte Micronucleus Test (OECD 474)
Toxicity studies
- Acute Oral Toxicity study in Rodent
- Maximum Tolerated Dose (MTD) toxicology studies in Mice/Rats
- Maximum Tolerated Dose (MTD) toxicology studies in non-rodents (Beagle dog/Minipigs/NHP*)
- Dose range finding (7 to 14 day) toxicology studies in Mice/Rats
- Dose range finding (7 to 14 day) toxicology studies in non-rodents (Beagle dog)
- 14 to 28 day repeat dose toxicity studies in Mice/Rats
- 14 to 28 day repeat dose toxicity studies in non-rodents (Beagle dog)
- 28-day neurotoxicity study in rodents
- 90-day repeat dose toxicity studies in Mice/Rats
- 90-day repeat dose toxicity studies in non-rodents (Beagle dog)
- 90-day neurotoxicity study in rodents
- Chronic Toxicity studies in Mice/Rats
- One year (12 month) Chronic toxicity study in non-rodents (Beagle dog)
- Carcinogenicity study in Mice/Rats
- Combined Chronic Toxicity/Carcinogenicity study in Mice/Rats
- Fertility and Early Embryonic Development (FEED) Study in Mice/Rats
- One Generation Reproductive Toxicity Study in Mice/Rats
- Two Generation Reproductive Toxicity Study in Mice/Rats
- Prenatal Developmental Toxicity Study in Mice/rats/Rabbits
- Neurotoxicity Study in Rats
- Developmental Neurotoxicity Study in Rats
- Pharmacokinetics study in Rats
- Metabolism/Toxicokinetics/Mass balance study in Rats
- Immunotoxicity studies
