| Autor: |
F. Aguilar, H. Autrup, S. Barlow, L. Castle, R. Crebelli, W. Dekant, K. H. Engel, N. Gontard, D. Gott, R. Gürtler, J. C. Larsen, C. Leclercq, J. C. Leblanc, F. X. Malcata, W. Mennes, M. R. Milana, I. Pratt, I. Rietjens, P. Tobback, F. Toldrá, GRILLI, SANDRO |
| Přispěvatelé: |
F. Aguilar, H. Autrup, S. Barlow, L. Castle, R. Crebelli, W. Dekant, K.-H. Engel, N. Gontard, D. Gott, S. Grilli, R. Gürtler, J. C. Larsen, C. Leclercq, J.-C. Leblanc, F. X. Malcata, W. Menne, M. R. Milana, I. Pratt, I. Rietjen, P. Tobback, F. Toldrá. |
| Jazyk: |
angličtina |
| Rok vydání: |
2007 |
| Předmět: |
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| Popis: |
According to the available evidence, ethyl lauroyl arginate is devoid of reproductive and developmental toxicity. Long-term carcinogenicity studies are lacking. However, the rapid metabolism of ethyl-Nα-lauroyl-L-arginate to compounds endogenously present in much higher levels, the absence of preneoplastic toxic effects in the in vivo studies performed, together with the absence of genotoxic activity in the mouse lymphoma assay, the human lymphocyte assay and the micronucleus test, does not suggest a carcinogenic potential. Therefore the Panel concludes that there is no need to perform carcinogenicity studies. The Panel notes that effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects cannot be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, that the NOAEL for this 52 week study is lower than the lowest dose levels tested, and thus lower than 106 mg/kg bw/day. This is in line with the NOAEL of 47 and 56 mg ethyl lauroyl arginate /kg bw/day for males and females respectively from the 13 week study with the 19.5 % formulation of ethyl lauroyl arginate in propylene glycol. Based on this NOAEL and a safety factor of 100, the Panel established an ADI of 0.5 mg ethyl lauroyl arginate of the proposed specifications /kg bw. The safety factor of 100 is considered sufficient in spite of the fact that the ADI is based on a 90-day study because the effects on white blood cells do not become more severe upon prolonged exposure. Potential dietary exposure to ethyl lauroyl arginate was estimated based on UK food consumption data and on the assumption that it would be present in all food categories for which use levels are proposed. Potential dietary exposure was found to be at or above the ADI in high consumers for both children aged 1.5 to 4.5 (580% of the ADI), children aged 4 to 18 (370% of the ADI) and adults (100% of the ADI). Potential mean dietary exposure to ethyl lauroyl arginate in consumers only was also at or above the ADI for both children aged 1.5 to 4.5 (170% of the ADI) and children aged 4 to 18 (106% of the ADI). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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