Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Data are available from a 28-day oral toxicity study and limited information is available from a 90-day oral toxicity study. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
200 mg/kg bw/day
Study duration:

Additional information

In the 28 -day study, at 200 mg/kg bw/day, slightly lower plasma chloride levels were observed in the males but not in the females. As this change was slight, not accompanied by other changes in this group, it was considered a NOAEL. In the 90 -day study, RIVM (see section 13) concluded that the LOAEL was 20 mg/kg bw/day based on dose-related statistically significantly increased urinary zinc levels in all male test groups, and elvated urinary zinc levels in females of the low and mid dose groups. However, based on the fact that increased urinary zinc levels without any other effects are not an adverse effect per se and because no such changes were seen in the females of the high dose group, it cannot be concluded that the LOAEL is indeed 20 mg/kg bw. Overall, the NOAEL was considered to be 200 mg/kg bw/day.

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: other

Justification for classification or non-classification

Based on a NOAEL of 200 mg/kg bw/day no classification for STOT repeated exposure (oral) is warranted. The effects observed at this level were slight.