Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
other:
Justification for type of information:
The brown algal seaweed is used in animal and human nutrition; in particular it is used as seaweed meal in Iceland, Ireland, Norway and UK. Animal nutrition: the most common seaweed source in animal nutrition in Europe is Ascophyllum nodosum; most data on its use are from Norway where it has been used since 1937. Human nutrition: the use in human nutrition is more common in Far East, particularly Japan, China and Korea, where the population eat more seaweed than in the West for both nutritional and industrial purposes. France is now the European country where seaweeds are used in human nutrition at the highest level. A. nodosum is used due to its ability to regulate bowel action, as source of amino acids and protein, vitamins and minerals and low fat content. Furthermore, seaweed extracts are included in Annex I of Directive 91/414/EEC, which requires a reduced package of studies for Plant Protection Products made from plants or plants extracts (SANCO Draft Working Document 10472/2003/rev. 5).

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Applicant's summary and conclusion