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Full Assessment Report. (Word5) ATTACHMENT 3 SAFETY ASSESSMENT REPORT APPLICATION A406 PERMISSION FOR USE OF NEOTAME SUMMARY Introduction The NutraSweet Company is seeking approval for the use of a new artificial sweetener (Neotame) in Australia and New Zealand. The proposed uses include, but are not limited to, soft drink beverages (both carbonated and non-carbonated), beverage concentrates, beverage mixes, dairy beverages, fruit juice products, alcoholic drinks, non-dairy desserts, gelatin, ice cream, breakfast cereals and as a tabletop sweetener for use in hot beverages such as tea or coffee. Neotame (L-phenylalanine, N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-,1-methyl ester; or NC- 00723) is a dipeptide methyl ester derivative, chemically-related to aspartame. It has a sweetness potency of 7000 to 13,000-times sweeter than sucrose, and 30 to 60-times that of aspartame, depending on the use. Neotame was very stable in mock beverage solutions simulating commercial formulations. The only degradation product formed at >1% was L-phenylalanine, N-[N-3,3-dimethylbutyl)- L-α-aspartyl (NC-00751), which is also the major metabolite in both animals and humans and other minor degradation products (each <1%) which are not expected to be detectable at actual use levels of Neotame. Metabolism and toxicokinetics A number of studies on the metabolism and toxicokinetics were performed in rats and dogs, mainly via the oral route, although the intravenous route was also investigated. Neotame was rapidly absorbed following oral dosing, with around 14% of the administered dose absorbed in a pilot metabolism study and around 20-30% absorbed in the definitive rat metabolism study. Hydrolysis of Neotame to L-phenylalanine, N-[N-3,3-dimethylbutyl)-L-α- aspartyl (NC-00751) occurred rapidly in all species tested. Excretion of Neotame and its metabolites was also relatively rapid and complete in all species tested. After oral dosing with radioactive Neotame, high levels were found in the stomach, the gastrointestinal tract, liver, kidney and bladder. There was no evidence of accumulation in any tissue. The major route of excretion was via the faeces, either without absorption or following absorption and biliary excretion (approximately 6% of the administered dose in the rat). Hydrolysis of Neotame to NC-00751 occurred during passage through the gastrointestinal tract. Oral treatment of rats with NC-00751 lead to absorption of around 4% of the administered dose. The majority of orally administered NC-00751 is excreted unchanged in the faeces within 48hrs. 23 Acute Toxicity Parent compound No acute toxicity studies were conducted with Neotame, however the levels administered in the short-term studies indicate that Neotame is likely to be of very low acute oral toxicity. Degradation products Single-dose oral gavage studies were conducted in rats on the degradation products, NC- 00764 and NC-00777 at up to 6.0 mg/kg bw/day and also on NC-00779 at up to 3.0 mg/kg bw/day. No deaths were seen over a 14-day observation period and no treatment related abnormal clinical signs were seen throughout the studies. Short-term studies Range-finding studies were conducted in mice, rats and dogs in order to establish dose regimes for long-term studies and to assess any initial signs of toxicity and identify target organs for toxicity at high dose levels. Diet palatability studies were also conducted in rats. Two dietary studies in mice were conducted at dose levels up to 300 mg/kg bw/day and 8000 mg/kg bw/day, respectively, for 14 days. In the first study, there was no evidence of treatment-related effects. In the second study, the only effect observed was a decrease in bodyweight gain at 500 mg/kg bw/day and above in females and at 4000 mg/kg bw/day and above in males. There was a decrease in food consumption seen at the highest dose level (8000 mg/kg bw/day). Two dietary studies in rats were conducted at dose levels up to 300 mg/kg bw/day and 6000 mg/kg bw/day, respectively, for 14 days. In the first study, the only effect observed was a decrease in bodyweight gain in both males and females at the 30 and 300 mg/kg bw/day dose levels. Food consumption was also significantly reduced in both sexes at these dose levels. In the second study, there were sporadic clinical and pathological changes that were not considered treatment-related. There was a significant decrease in bodyweight in males at 4000 mg/kg bw/day and above and in females at 6000 mg/kg bw/day. Bodyweight gain was decreased in males and females at 2000 mg/kg and above. Food consumption was decreased from 2000 mg/kg bw/day in males and from 600 mg/kg bw/day in females. A dietary study in dogs was conducted at dose levels up to 300 mg/kg bw /day for 14 days. The only effect observed was a decrease in bodyweight gain from 30 mg/kg bw/day in males and from 300 mg/kg bw/day in females. This was accompanied by a decrease in food consumption. Other observed changes were considered incidental. Two palatability studies were conducted in rats to examine the effect of increasing concentrations of Neotame in the diet up to 15000 ppm (equivalent to 1000 mg/kg bw/day). Preference for an untreated diet was observed at dose levels of 150 ppm Neotame and above in the diet (equivalent to 10 mg/kg bw/day). At the highest dose level, virtually none of the treated diet was eaten by preference. When offered treated diet only, total food consumption was decreased from 5000 ppm (equivalent to 100 mg/kg bw/day). Bodyweight gain was decreased at 5000 ppm in the diet and above. 24 Subchronic studies Subchronic studies have been conducted in mice, rats and dogs. A dietary study in mice was conducted at dose levels up to 8000 mg/kg bw/day for 13 weeks. Bodyweight gain was decreased in both sexes in the early part of the study at 1000 mg/kg bw/day and in males throughout the study at 4000 (intermittently) and 8000 mg/kg bw/day. These decreases are considered to be related to a reduction in palatability as food consumption was decreased from 1000 mg/kg bw/day in males and in both sexes at higher dose levels. There was a treatment-related increase in absolute and relative liver weight in both males and females. Absolute liver weight was increased at 8000 mg/kg bw/day, while the relative liver weight was increased at 4000 and 8000 mg/kg bw/day. These changes were not accompanied by histopathological changes or changes to clinical chemistry parameters. The NOEL, based on liver weight changes, was 1000 mg/kg bw/day. A dietary study in rats was conducted at dose levels of up to 3000 mg/kg bw day for 13 weeks followed by a 4 week reversibility period. There was a decrease in bodyweight and bodyweight gain in both sexes at 3000 mg/kg bw/day. These decreases are considered to be related to a reduction in palatability as food consumption was decreased from 1000 mg/kg bw/day in males and 100 mg/kg bw/day in females. There was a treatment-related decrease in plasma cholesterol levels at 1000 mg/kg bw/day and above. A number of organ weight changes were observed at 3000 mg/kg bw/day. The NOEL, based on the changes in plasma cholesterol, was 300 mg/kg bw/day. A dietary study in dogs was conducted at dose levels of up to 2000 mg/kg bw/ day (reduced to 1200 mg/kg bw/day after 3 weeks) for 13 weeks followed by a 4 week reversibility period. There was a significant decrease in bodyweight in both sexes at the high dose level and in bodyweight gain from 600 mg/kg bw/day. These decreases are considered to be related to a reduction in palatability as food consumption was decreased also at these dose levels. There were significant treatment-related changes in some clinical chemistry parameters from the 600 mg/kg bw/day dose level. Absolute and relative liver weight was increased from 600 mg/kg bw/day in females and at high-dose in males but was not accompanied by histopathological changes (absolute weight increases not statistically significant). The NOEL, based on clinical pathology changes and on relative liver weight changes, was 200 mg/kg bw/day. Chronic toxicity / carcinogenicity studies Chronic toxicity/carcinogenicity studies have been conducted in mice, rats and dogs. A dietary study in mice was conducted at dose levels up to 4000 mg/kg bw/day for 104 weeks. There was a decrease in bodyweight in both sexes at dose levels of 400 mg/kg bw/day and above. Bodyweight gain was decreased in males from 400 mg/kg bw/day and in females from 50 mg/kg bw/day. These decreases are considered to be related to a reduction in palatability as food consumption was decreased also at these dose levels. There were no treatment-related organ weight changes. The small non-significant increase in adenomas in male mice at the high dose level was not accompanied by an increase in pre-neoplastic lesions and was not considered treatment-related. The NOEL, based on the absence of adverse effects at the highest dose tested, was 4000 mg/kg bw/day. 25 A dietary study in rats was conducted at dose levels up to 1000 mg/kg bw/day for 52 weeks followed by a 4-week reversibility period. There was a decrease in bodyweight in both sexes at dose levels of 100 mg/kg bw/day and above.
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