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Administrative data

Description of key information

The oral LD50 of DOI is > 2000 mg/kg bw (with no mortality at this dose level).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

In an acute oral toxicity study according to OECD 423, and GLP, scored as validity 1 according to Klimisch criteria, groups of fasted female Wistar rats were given a single oral dose of DOI in corn oil at the dose of 2000 mg/kg bw and observed for 14 days.

Under the experimental conditions, the oral LD50 of the test item DOI was higher than 2000 mg/kg in rats.

No classification for acute oral toxicity is warranted based on the absence of mortality up to 2000 mg/kg bw, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP. Similar results were obtained with Isosorbide diesters (see section 7.2.1)

Taking into account these acceptable data, we can conclude that the test item is not classified as harmful if swallowed according to CLP criteria.

 

Acute dermal toxicity:

No data available.

 

Acute inhalation toxicity:

No data is available.


Justification for selection of acute toxicity – oral endpoint
GLP and OECD guideline

Justification for classification or non-classification

DOI induces no mortality in the rat following a single exposure by oral route up to a limit dose and thus should not to be classified for acute toxicity via the oral route as defined by the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS classification criteria.

No data are available by dermal route or by inhalation.