Registration Dossier
Registration Dossier
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EC number: 220-250-6 | CAS number: 2687-91-4
Carcinogenicity
Administrative data
Description of key information
N-Ethyl-2 -Pyrrolidone (NEP) is non mutagenic in the Ames test (OECD 471) and the mammalian cell gene mutation assay (HPRT; OECD476). No clastogenicity was found in a chromosomal aberration test (OECD 473). Therefore, NEP is considered to be non mutagenic. In repeated dose studies there was no indications of preneoplastic changes in target organs.
According to column 2 Annex X it is not necessary to conduct a carcinogenicity study. NEP, therefore, is considered to be non-carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification is not warranted according to the criteria of EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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