Registration Dossier

Administrative data

Description of key information

Very low acute toxicity with oral LD50 of 19.500 mg/kg and no acute effects observed dermally at a dose of 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
19 500 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Additional information

No human data is available. In animals, TNPP has a very low acute toxicity by the oral route, with a LD50value of about 19.5 +/- 3.3 gram/kg bw for the rat. Hemorrhagic lesions in the gastro-intestinal tract and the lungs are seen in some animals, following the administration of a lethal dose. This value was used for the risk assessment. The other studies couldn’t be used in the risk assessment due to shortcomings or unavailable study reports. Furthermore a LD50could not be derived from these studies as no mortality was observed at doses up to the highest doses tested (about 10 g/kg). Nevertheless, these results are in accordance with the value of 19.5 g/kg bw derived from the study from Naugatuck (1957).

The acute toxicity of TNPP by the dermal route seems to be very low too, with a LD50greater than 2000 mg/kg in rabbits. No data is available on the acute inhalation toxicity, although the non-corrosive and non-irritant nature of TNPP (see section 4.1.2.3.1 on skin irritation) may suggest that toxicity would not be enhanced following exposure by this route.

 

By intraperitoneal route, the LD50was found to be > 1000 mg/kg in rats.

Justification for classification or non-classification

According to the criteria of the European Union, this chemical does not need to be classified on the basis of its acute toxicity.