Registration Dossier

Administrative data

Description of key information

1. BASF AG, 2005. N-Ethyl-2-pyrrolidon - Murine Local Lymph Node Assay (LLNA). Report No.45H0033/042269. Data waiving from a related substance.
2. Kodak 1984, Letter from Eastman Kodak to US EPA RE: Chemical listed in the ´83 List of Chemicals selected for Review by TSCA ITC (48 FR 5152), W/Attachments: unpublished Tox. Lab. Repor. Report No.104659A. Guinea pig: N-methylpyrrolidone was tested.
3. Kodak 1984, Human

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

N-ethylpyrrolidone, a related substance to 2 -pyrrolidone was applied in three different concentrations (3%, 10% and 50% in acetone) to the dorsum of both ears of mice for three consecutive days (BASF, 2005). On day six the lymph nodes were removed, and number of proliferated lymphocytes were counted. Thereafter the stimulation indices were calculated. The cell count and the lymph node index were slightly increased only in the highest preparation group. This observation is considered not to be treatment related. The test material did not induce a positive response in LLNA. 1-ethylpyrrolidin-2-one is not sensitizer in this assay.

Additionally, 2-Pyrrolidone was reported as “not a potent skin sensitizer” following unspecified human patch tests (refer to section 7.10.4 of IUCLID file).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Actually, there is no indication given for a classification according to this endpoint (no case reports known; non-sensitizing LLNA read across).

Migrated from Short description of key information:
There is no test system for this endpoint

Justification for classification or non-classification

Classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.