. 2019 Jul 17;17(7):e05749. doi: 10.2903/j.efsa.2019.5749

Table E.2.

Reproductive toxicity study on [FL‐no: 08.085] (i.e. sorbic acid) considered by the FAF Panel in scientific opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives (EFSA FAF Panel, 2019)

EU Union List Name [FL‐no]	Species; Sex No./Group	Route	Dose levels (mg/kg bw per day)	Duration	BMDL (BMR set to 5% producing a lower bound)	Reference	Comments
(E,E)‐Hexa‐2,4‐dienoic acid [FL‐no: 08.085] (sorbic acid)	CD/Crl:CD rats cohorts 1A and 1B (reproductive toxicity) 25 animals/sex per group in the F0‐generation; 20 animals/sex per group to cohort F1A and F1B	Diet	0, 1,000, 2,000 and 4,000 mg sorbic acid/kg bw per day	Extended one‐generation	1110 mg sorbic acid/kg body weight (bw) per day	Documentation provided to EFSA n. 1 in EFSA FAF Panel (2019)

EU Union List Name [FL‐no]

Species; Sex No./Group

Route

Dose levels (mg/kg bw per day)

Duration

BMDL (BMR set to 5% producing a lower bound)

Reference

Comments

(E,E)‐Hexa‐2,4‐dienoic acid [FL‐no: 08.085]

(sorbic acid)

CD/Crl:CD rats

cohorts 1A and 1B (reproductive toxicity)

25 animals/sex per group in the F0‐generation;

20 animals/sex per group to cohort F1A and F1B

Diet

0, 1,000, 2,000 and 4,000 mg sorbic acid/kg bw per day

Extended one‐generation

1110 mg sorbic acid/kg body weight (bw) per day

Documentation provided to EFSA n. 1 in EFSA FAF Panel (2019)

bw: body weight; BMR: benchmark response.