Registration Dossier
Registration Dossier
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EC number: 429-330-7 | CAS number: 110057-45-9
Endpoint summary
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.
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