Pyridoxine hydrochloride

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

A review of the available animal and human data has been carried out by the SCF in regard to human oral exposure in the publicly available document 'Tolerable upper intake levels for vitamins and minerals' in 2000, and confirmed by EFSA in 2006 and 2016. The data reviewed includes animal studies in rats, dogs, guinea pigs and mice at a wide range of daily doses and time periods ranging from 6 to 112 days. The human data reviewed includes clinical studies on both men and women taking daily doses ranging 40 to 3000 mg/day and up to maximum duration of 24 years. The data was adequate to allow the derivation of a tolerable upper intake level in adults of 25 mg/day for Vitamin B6. The data showed no indication for adverse effects on reproduction and fetal development and there are no subgroups that are known to be unusually susceptible to the adverse effects of vitamin B6. Therefore the UL of 25 mg per day should be considered to apply also to pregnant and lactating women. Considering the available data, it is unnecessary to carry out further testing on toxicity to reproduction.