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Key value for chemical safety assessment

Additional information

In vitro studies:
N-Vinylformamide was not mutagenic in the Ames test in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538, both in the presence and in the absence of S-9 mix from Aroclor 1254 induced rats, when tested up to the limit dose level of 5000 µg/plate (Air Products and Chemicals, Inc. 1992, BASF AG 1985). Up to this concentration no bacteriotoxic effect was observed.
N-Vinylformamide was tested in the CHO/HPRT mutation assay in the absence and presence of metabolic activation with phenobarbital and
β-naphthoflavone-induced rat liver S-9 (BASF SE 2010). The assay was conducted according to OECD TG 476 at dose levels of 750, 375.5, 187.5, 93.8 or 750, 500, 250 and 125 μg/ml in non-activated and activated studies. The cells were exposed for 4 or 24h. No cytotoxicity was observed up to 750 µg/ml. Under the conditions of this mutagenicity test, N-Vinylformamide was negative in both the absence and presence of exogenous metabolic activation. Supportingly, N-Vinylformamide was tested in the CHO/HGPRT mutation assay in the absence and presence of metabolic activation with Aroclor-induced rat liver S-9 (Air Products and Chemicals, Inc. 1992). The assay was conducted at dose levels of 5000, 2500, 1250, 625 and 312.5μg/ml in both the non-activated and activated studies. No cytotoxicity was observed up to 5000 µg/ml. Under the conditions of this mutagenicity test, N-Vinylformamide was negative in both the absence and presence of exogenous metabolic activation.

N-Vinylformamide was tested in the micronucleus assay in V79 cells in the absence and presence of metabolic activation with phenobarbital and
β-naphthoflavone-induced rat liver S-9 (BASF SE 2010). The assay was conducted according to draft OECD TG 487 (version 5, 2009). Dose levels of 750, 375, 187.5, 93.8 and 46.9 µg/ml were used for 4h exposure with and without metabolic activation and 24 exposure with metabolic activation. Exposure for 4h with and without S9 was also tested at dose levels of 750, 500, 375 and 187.5 µg/ml. No cytotoxicity was observed up to 750 µg/ml. Under the conditions of this mutagenicity test, N-Vinylformamide was negative in both the absence and presence of exogenous metabolic activation.
Conclusion: In vitro, N-Vinylformamide was negative in bacterial (Ames test), mammalian (CHO/HGPRT) mutation, mammalian (CHO/HPRT) mutation, and mammalian micronucleus assays both in the presence and in the absence of metabolic activation.

 

In vivo studies:

Supporting to the negative result in the in vitro micronucleus assay (BASF SE 2010), N-Vinylformamide has been tested in an in vivo micronucleus assay (Air Products and Chemicals, Inc. 1992). Male ICR mice were exposed to 19, 38, or 75 mg/kg and female ICR mice to 29, 58, or 115 mg/kg of the test substance which was administered in a total volume of 10 ml/kg as a single intraperitoneal injection. No reduction in the ratio of polychromatic erythrocytes (PCE) to total erythrocytes was observed in the test article-treated groups relative to the vehicle control suggesting that the test substance did not induce bone marrow toxicity. N-Vinylformamide was negative in the induction of micronuclei in anin vivomouse micronucleus test.
Conclusion: In vivo, a micronucleus test using intraperitoneal injection of N-Vinylformamide in ICR mice was negative.


Short description of key information:
In vitro, N-Vinylformamide was negative in bacterial (Ames test) and mammalian mutation assays (CHO/HGPRT and micronucleus test in V79 cells) both in the presence and in the absence of metabolic activation. In vivo, a micronucleus test using intraperitoneal injection of N-Vinylformamide in ICR mice was negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

no classification required