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Administrative data

Description of key information

One well conducted 28-day oral toxicity study was available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

The NOAEL in the 28 -day oral toxicity study with PDTN was based on hepatic changes, characterised by increased liver weights, increased alanine aminotransferase activity and centrilobular hepatocyte hypertrophy. In addition, clinical symptoms comprised a hunched posture, piloerection, red discolouration of the urine and severe brown staining of the fur. These were observed at 1000 mg/kg bw. The next lower level of 200 mg/kg did not show these changes and was therefore considerd to be the NOAEL.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

Based on the available data (liver effects at 1000 mg/kg) and a NOAEL of 200 mg/kg bw, no classification for STOT repeated is required.