Registration Dossier

Administrative data

Description of key information

Reliable information on repeated dose toxicity shows a NOAEL of 2500 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
2 500 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

PETN was found to be nontoxic to both rats and mice in a 13/14-week studies. No effects such as increase in methemoglobin were observed. As no evidence of toxicity of pentaerythritol tetranitrate in the 2- or 13-week studies was found, a 2 -year study on rats and mice was carried out using the maximum dietary concentrations recommended for chronic studies. Survival of treated male rats and male mice was higher than that of controls. No effects directly attributable to the ingestion of pentaerythritol tetranitrate were found.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: heart; cardiovascular / hematological: thymus; digestive: liver; neurologic: brain (multiple sections); respiratory: lung; urogenital: kidneys

Justification for classification or non-classification

No classification is proposed based on results obtained from the studies.