Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

One-generation study in the rat by oral route (gavage): no evidence of toxicity to reproduction.

Three-generation study in the rat by oral route (diet): no evidence of toxicity to reproduction

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
Additional information

In a one-generation study realised according to the OECD guideline 415 and in compliance with GLP, the NOEL in rat by oral route has been found to be 1000mg/kg/d (highest dose tested) for fertility and effects on reproduction in parental animals and for effects in F1 generation. A published three-generation study in rats administered ADCA in the diet at 7.5ppm also showed no effects on parents or offsprings of the three generations. This last study is not GLP and was performed before OECD guidelines where in place.

Effects on developmental toxicity

Description of key information

Based on these existing data, there is no evidence of reproductive and developmental toxicity. According to the Guidance on Information Requirements and Chemical Safety Assessment, no further data is required for the assessment of the developmental toxicity of ADCA.

The developmetal toxicity / teratogenicity test is therefore proposed to be waived.

Justification for classification or non-classification

No classification is required, as no effect on reproduction has been observed in the available studies at the highest doses tested.