Advisory Committee on Pesticides Annual Report 2001

Section E: UK Review Programme
The <strong>Committee</strong> agreed that, as IMS was a condition resulting from serious
acute poisoning, it was likely that those developing the syndrome would
already be hospitalised, and as IMS rarely occurred in the UK, it was not
necessary for approval holders to include guidance on the treatment of IMS
on the product label.
The <strong>Committee</strong> considered the potential for fenitrothion to cause skin
sensitisation. It was noted that fenitrothion had been widely used for many
years and that it was highly likely that any potential for fenitrothion to cause
skin sensitisation would be reflected in the clinical literature. Therefore, in
light of the lack of reported cases of skin sensitisation, the <strong>Committee</strong> agreed
there were no grounds for concern on this issue.
The <strong>Committee</strong> agreed that the evidence presented indicated that fenitrothion
was not genotoxic and that ocular toxicity gave no cause for concern.
Observations in developmental studies included the occurrence of enlarged
sub-arachnoid space in rat pups and decreases in pup survival postpartum at
high doses. The <strong>Committee</strong> examined the data and agreed that the occurrence
of enlarged sub-arachnoid space was not treatment related. The <strong>Committee</strong>
also agreed that the decrease in pup survival postpartum seen at high doses
could be related to the palatability of the mother’s milk and concluded that
as these effects were seen only at high doses, there were no concerns for
human health.
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The <strong>Committee</strong> considered the predicted exposure of users of products
containing free fenitrothion for public hygiene and animal husbandry uses and
concluded that, with the exception of aerosol space sprays used professionally
in industrial premises, approvals should be revoked. This was because of
inadequate reassurance that exposures of users or consumers would be
acceptable. The <strong>Committee</strong> also considered that further data presented by
the data holder were not sufficient to support the continued approval of
wettable powders and dust formulations.
The <strong>Committee</strong> agreed that the data submitted indicated that
microencapsulated fenitrothion was far less toxic than free fenitrothion.
It recommended that approval for products containing microencapsulated
fenitrothion should be allowed to continue for use in industrial areas only,
and subject to a number of data requirements. In addition to these data
requirements, for approval to be allowed to continue for professional use
aerosol space sprays containing free fenitrothion in industrial areas, further
data were requested. Any future request to extend approval for