Title: Alternative Sweeteners

Table 7 Summary of Pivotal Toxicity Studies on Erythritol
Title of study Erythritol dosage Duration Findings
1. Oral toxicity (34) 0, 5, 10% 4 weeks No significant toxicological effects
Animal: Wistar rats (male and female)
2. Subchronic oral toxicity (35) 0, 5, 10, 20% 90 days No treatment-related abnormalities based on
Animal: mice, rats histopathological examination
3. Embryotoxicity and teratogenicity (36) 0, 2.5, 5, 10% Day 0 to 21 of No fetotoxic, embryotoxic, or teratogenic ef-
Animal: rats gestation fects
4. Two-generation reproduction study (37) 0, 2.5, 5, 10% Two generations No adverse effect on fertility and reproduc-
Animal: rats tive performance of parents and on the development
of their progeny
5. Teratology study (38) 1.0, 2.24, 5.0 g/kg Daily from days No effect on reproductive performance or in
Animal: rabbits intravenously 6 to 18 of fetal development
gestation
6. Chronic oral toxicity (39) 0, 2, 5, 10% 53 weeks Daily consumption of up to 3.5 g/kg body
Animal: dogs weight was well tolerated
7. Mutagenicity (40) 15.8 to 50,000 Negative in reverse mutation assays and nega-
Organism/cell line: Salmonella typhimu- µg/plate tive in chromosome aberration tests
rium
Escherichia coli
Chinese hamster fibroblast cell
8. Chronic toxicity and carcinogenicity (41) 0, 2, 5, 10% 104–107 weeks No evidence of tumor-inducing or tumor-
Animal: rats (male and female) promoting effect
Erythritol 249