Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The test subtance is not acutely toxic for the oral and dermal route. In both studies, the LD50 is >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Based on the available information, the acute toxcity of the test substance is low for the oral and dermal route of administration. In both studies, the LD50 is >2000 mg/kg bw. There is no study available for the inhalation route. Even though there is no information on acute toxicity is humans, there is no resaon to believe that the low acute toxicty observed in experimental animals would not be relevant for human health.


Justification for selection of acute toxicity – oral endpoint
Study conducted according to OECD guideline 423 and under GLP.

Justification for selection of acute toxicity – dermal endpoint
Study conducted according to OECD guideline and under GLP.

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for acute toxicity, according to the Regulation EC 1272/2008 and the Directive 67/548/EEC.