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Description of key information

The key study for repeat dose oral toxicity (Hooiveld & van Otterdijk, 2004) reported an oral NOAEL value of 1000 mg/kg bw/day (the highest dose tested).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day
Study duration:

Additional information

The key study (Hooveld & van Otterdijk, 2004) was conducted according to the OECD 407 guideline under conditions of GLP. The test was performed on male and female Wistar rats for an exposure period of 28 days. Doses of 0, 150, 500 and 1000 mg/kg bw/day were prepared in propylene glycol and administered via oral gavage.

No clinical or behavioural effests were observed during the exposure period. Increases in food consumption and bodyweight were considered to be weak or incidental. No toxicologically significant changes in organ weight or appearance were noted at necropsy.

Under the conditions of the study the NOAEL was considered to be 1000 mg/kg bw/day.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

Justification for classification or non-classification

Based upon the key information (Hooveld & van Otterdijk, 2004) the registered substance does not meet the criteria for classification as set out by EC Regulation 1272/2008 or directive 67/548/EEC.

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