Study ID 1016	Young‐Shin Chung and Michael Lee. Genotoxicity assessment of erythritol by using short‐term assay. Toxicology research vol. 29, No. 4, pp. 249–255 (2013)
Funding	Funding source (public/private): public
Good laboratory practice (GLP) compliance and guideline	Good laboratory practice (GLP): no Guideline studies (if yes, specify): OECD TG 471 (1997), TG 473 (1997), TG 487 (2010) and TG 474 (1997)
Test system	Salmonella/microsome (Ames) test, strains Salmonella typhimurium TA98, TA1537, TA100, TA1535 and Escherichia coli WP2 uvrA (with and without metabolic activation), chromosomal aberrations in chinese hamster fibroblasts (CHL), in vitro micronucleus and comet assays in L5178Y mouse lymphoma cells (with and without metabolic activation), In vivo micronucleus test in mouse bone marrow
Test material	Identity, batch, purity: commercial sample purchased at a local (Korean) marketplace
Exposure/treatment conditions	Ames test: plate incorporation assay (doses; 156, 312, 625, 1250, 2500 and 5000 μg/plate) Chromosomal aberration test: short (6 h, with and without metabolic activation) and continuous (24 h, without metabolic activation) treatments with 1250, 2500 and 5000 μg/mL In vitro micronucleus: short (3 h + 21 h recovery, with and without metabolic activation) and continuous (24 h, without metabolic activation) treatments with 1250, 2500 and 5000 μg/mL; cytochalasin B was not used as cyt B is known to increase spontaneous background of micronuclei in L5178 cells Comet assay: short (3 h, with and without metabolic activation, without recovery) and extended (24 h, without metabolic activation) treatment with 1250, 2500 and 5000 μg/mL In vivo micronucleus test: two daily oral administrations of 1250, 2500 and 5000 mg/kg. Mice were sacrificed 24 h after the final administratio
Results	No increase in revertant colonies in the Ames test; no significant and dose related increase in aberrant metaphases or micronuclei In comet assays, a significant (≤2‐fold) increase in mean % tail DNA was observed at the top concentration (5000 μg/mL) after short treatment without S9, and at the middle (2500 μg/mL) and high concentration after continuous 24 h treatment In vivo micronucleus in mouse bone marrow: inconclusive, i.e. negative as regards the formation of micronucleated PCEs, but with no evidence of bone marrow exposure based on no decrease in the PCE/NCE ratio
Reliability of the study/Relevance of the test system/Relevance of the results	Reliability: The experimental protocols used in the Ames test, in vitro chromosomal aberration and in vitro micronucleus tests are basically in agreement with the relevant OECD guidelines, even though the number of scored metaphases in the chromosomal aberration test was lower than currently recommended (200 instead of 300 as in TG 473, 2016). It is also noted that the dose range applied in mammalian assays exceeded the maximum concentration recommended in the updated TG473 and TG487 (2014/2016), but this did not impair the validity of the studies as no overt toxicity was observed at any dose There is no OECD guideline for the in vitro comet assay, which was performed following a published protocol. Overall, the in vitro studies are considered reliable without restrictions (Ames test and in vitro micronucleus tests) or with restrictions (in vitro chromosomal aberrations and comet assays) The in vivo micronucleus tests provided inconclusive results, and therefore it is considered as ‘reliability insufficient’ Relevance of the test system: High relevance is given to the Ames test, and the in vitro chromosomal aberration and micronucleus tests, which are mutational events. Limited relevance is given to the in vitro comet assay, as an indicator endpoint Relevance of the result: High relevance is given to the results of the Ames and in vitro micronucleus test; limited relevance to the results of the chromosome aberration test and the in vitro comet assay; low relevance to the results of the in vivo micronucleus test (for the inconclusive result)