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Note for the attention of Dr Tim Bowmer, Chairman of the Committee for Risk Assessment
Ref: Request to the Committee for Risk Assessment to review new information in relation to the harmonised classification and labelling of the substance DTPA-H5, DTPA-K5 and DTPA-Na5.
The Committee for Risk Assessment (RAC) is requested to review the information provided by the dossier submitters in addition to the information already assessed by RAC during the opinion development in 2017, and, if necessary, to amend the opinion of 9 June 2017 in relation to the classification for reproductive toxicity of DTPA-H5, DTPA-K5 and DTPA-Na5 and/or the setting of specific concentration limits.
Following the opinion, the dossier submitters provided information, additional to the information assessed by RAC, on the differences in zinc metabolism between rat and humans. The dossier submitters claim that the additional information demonstrates that the mechanism of maternal zinc depletion, which they believe to be the reason for the developmental effect seen in rats, is not relevant for humans. The dossier submitters conclude that developmental effects are unlikely to occur in humans and that it is thus not warranted to classify the substance as toxic for reproduction Cat. 1B.
Link to the Request for harmonised classification and labelling of new substance N-carboxymethyliminobis
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