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. 2020 May 14;18(5):e06098. doi: 10.2903/j.efsa.2020.6098

Table 8.

List of toxicological studies conducted with 3’‐SL produced by enzymatic synthesis

Test material Reference Type of study Experimental details
3’‐SL (98.8%) Kim et al. (2018) Bacterial Reverse Mutation Test 5, 10, 50, 100, 250, 500, 1,000, 2,500 and 5,000 μg 3’‐SL mL; ± S9
In vitro chromosome aberration test (CHL) 5, 10, 50, 100, 250, 500, 1,000, 2,500 and 5,000 μg 3’‐SL/mL; ± S9
In vivo mammalian Cell Micronucleus Test 500, 1,000 and 2,000 mg 3’‐SL/kg bw
Acute Toxicity Study in the SD Rat 5 SD rats/sex per group; 5,000, 10,000, 15,000 and 20,000 mg 3’‐SL/kg bw per day
28‐day GLP repeated dose oral toxicity study in the SD rat 10 SD rats/sex per group; 500, 1,000, 2,000 mg 3’‐SL/kg bw per day
90‐day GLP repeated dose oral toxicity study in the SD rat 10 SD rats/sex per group; 500, 1,000, 2,000 mg 3’‐SL/kg bw per day

CHL: Chinese hamster lung; SD: Sprague‐Dawley.