Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
Prenatal developmental toxicity study in rat (oral): NOAEL = 500-2000 mg/kg/d (with the analogous substance DEI)
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Additional information

There is no data available on DOI. However the potential for toxicity to reproduction of the substance was assessed by analogy with the analogous substance DEI.

The potential of DEI to induce effects on development was assessed in a prenatal developmental study performed according to OECD guideline No 414 and in accordance with GLP.DEI administered at the doses of 0.5, 1 and 2 g of DEI/kg, except a marginal reduction in ossification parameters at 2.0 g of DEI/kg, which was a consequence of a slightly higher incidence of foetuses of low body weight less than 3g, did not cause any effects on the embryo-foetal development in the rat.

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, and given the low level of toxicity to reproduction at the highest dose of 2000 mg/kg bw/d administered in rats in a prenatal developmental toxicity study (OECD 414, GLP) performed with the analogous substance DEI, no classification for reproductive and developmental toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.