Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
25 mg/kg bw/day
Additional information

Two-generation reproduction study in the rat (Nemec, 1996):

Based on reduced body weight and food consumption in F0 and F1 dams, the NOAEL for maternal systemic toxicity was determined to be 180 ppm (10 mg/kg bw/day). Reproductive parameters such as fertility, mating, days between pairing and coitus, gestation and parturition were not adversely affected by ziram administration. The NOAEL for reproductive toxicity is therefore considered to be 540 ppm (25 mg/kg bw/day).

In the examination of post-natal development in rats, the primary findings were a slight decrease in mean pup body weight in the F1 generation at the mid dose of 180 ppm during lactation. A similar effect was observed for F2 offspring andthroughout the remainder of the study until the postnatal day 70 neuropathology evaluation. Thus, the foetal and post-natal NOAEL for this study was determined to be 180 ppm (10 mg/kg bw/day) for ziram administered in the diet.

NOAEL (maternal) = 10 mg/kg bw/day,

NOAEL (repro) = 25 mg/kg bw/day,

NOAEL (foetal) = 10 mg/kg bw/day.


Short description of key information:
No specific effects on fertility.

Effects on developmental toxicity

Description of key information
No specific develomental effects.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
9 mg/kg bw/day
Additional information

The overall NOAELs derived from the teratology studies in rabbits and rats are 3 mg ziram/kg bw/day for maternal and 4 mg ziram/kg bw/day for teratogenicity/embryotoxicity.

NOAEL (maternal) = 6.8 mg/kg/ day,

NOAEL (foetal) = 9.0 mg/kg/ day.

Justification for classification or non-classification