Registration Dossier

Administrative data

Description of key information

The acute oral LD50 of N-(n-octyl)-2-pyrrolidinone is 2050 mg/kg bw. No other toxicity testing is undertaken.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 050 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Two acute oral toxicity tests were available in the ECHA migrated NONS file. In one the LD50 was found to be >2200 mg/kg bw in the other 2050 mg/kg bw. Neither result would trigger classification.

It is concluded that the acute oral LD50 for N-(n-octyl)-2 -pyrrolidinone is 2050 mg/kg bw, as this is the worst case scenario.

Two acute dermal toxicity tests were available in the ECHA migrated NONS files. In one, the LD50 is found to be >2000 mg/kg bw, and in the other it is found to be >4000 mg/kg bw. However, the second study is more reliable, following a clearly stated guideline in EU method B.3 and OECD 402, and being carried out in accordance with GLP standards, whereas the first study is carried out to GLP standards, but does not follow a specified guideline.

In conclusion, the lower acute dermal LD50 value of 2000 mg/kg bw is accepted as being the relevant endpoint, due to it being the worst case value found, in spite of it being taken from a less reliable study.

Justification for classification or non-classification

The acute oral LD50 of N-(n-octyl)-2-pyrrolidinone was found to be 2050 mg/kg bw, which is above the trigger value for any EU classification.

The acute dermal LD50 of N-(n-octyl)-2 -pyrrolidinone was found to be 2000 mg/kg bw, which is above the trigger for any EU classification.