Registration Dossier

Administrative data

Description of key information

Repeated dose toxicity study (GLP, OECD 407): subacute (28 d): NOAEL 1000 mg/kg bw/day
As a consequence, no distinct chemical safety assessment, including exposure determination and risk characterisation, has to be performed in accordance with article 14(4) of the REACH regulation.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

In a subacute repeated dose (28 d) GLP-study with oral administration acc. to OECD guidline 407, no substance related effects were observed. Therefore, the NOAEL of the test item for the oral route was determined to be the highest dose utilised, i.e. 1000 mg/kg bw/day. This result is further supported by the fact that also in an acute oral toxicity study no signs of toxicity were observed

In accordance with the data requirements as laid down in annexes VII - X of the REACH regulation, no further repeated dose toxicity studies had to be performed.

Justification for classification or non-classification

Since neither any classification criteria according to GHS/CLP (Regulation (EC) No. 1272/2008) nor any criteria according to DSD (Directive 67/548/EEC) are fulfilled, the substance is not classified for repeated dose toxicity.