Registration Dossier

Administrative data

Description of key information

28-day toxicity in the rat by the oral route followed by a 14-day recovery period: NOAEL = 2000 mg/kg bw/d (with the analogous substance DEI)
13-week oral toxicity study in the rat including recovery and TK: NOAEL = 2000 mg/kg bw/d (with the analogous substance DEI)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

Additional information

There is no data available on the test item, but the repeated dose toxicity of DOI was assessed by analogy with DEI.

DEI was tested for oral repeated dose toxicity in rat according to OECD guideline 407 (4 weeks) and according to OECD 408 (13 weeks). Under the experimental conditions, DEI administered at the doses of 0.5, 1 and 2 g of DEI/kg for 4 or 13 weeks did not induce any sign of toxicity. Therefore, the No-Observed-Adverse Effect Level (NOAEL) of DEI is equal to 2 g of DEI/kg.


Repeated dose toxicity: via oral route - systemic effects (target organ) other: all gross lesions and masses

Justification for classification or non-classification

By analogy with DEI, based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, and given the absence of signs of toxicity up to the highest dose of 2000 mg/kg bw/d administered in rats by gavage during 4 and 13 weeks, no classification for repeat-dose toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.