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EC number: 451-160-7
CAS number: 17913-76-7
surfactants are known to be useful promoters of drug absorption from the
gastrointestinal tract3. The
primary basis for improved GI absorption are surfactant effects on drug
solubility, dissolution, emulsification, micellar solubilization and
gastric emptying3. Some
nonionic surfactants are known to promote drug absorption by a direct
effect on gastric membranes3. The
electrical neutrality on nonionic surfactants generally make them less
toxic and nonionic surfactants possess relatively less direct toxicity
than cationic or anionic surfactants to gastrointestinal mucosa3. Members
of the AGDS category are not acutely toxic by the oral route in the rat,
the dermal route in rabbits or by inhalation in rats. The
lack of systemic toxicity in 28-day repeat dose toxicity studies in rats
by the oral route is a further indication of a lack of absorption and
toxicity through the gastrointestinal tract.
low vapor pressure exerted is an indication of low potential exposure by
the inhalation route as well. Surfactants in general are known to have a
direct irritant effect on the mucous membranes of the eyes and the upper
been generally shown when using surfactants in cosmetics that
percutaneous absorption of nonionic surfactants is greater than that for
anionic or cationic surfactants4. The
rate of skin absorption of nonionic surfactants decreases with
increasing levels of ethoxylation4. Nonionic
surfactants tend not to interact with proteins in the skin4.
It is likely that Surfynol 400 and Surfynol 2502 will have even less
dermal absorption than the other members of the AGDS category. None
of the members of the category were shown to be toxic by the dermal
route however which supports that the conclusion that dermal absorption
is relatively low for all members of the class. It is also possible that
substantial damage to or removal of the epidermal layer of the skin
would enhance dermal absorption of the members of the AGDS category.
evidence of systemic target organ toxicity was seen in repeat dose
studies in the rat given members of the AGDS category by the oral route1.
Toxicity seen in the liver at the highest dose tested is likely the
result of compensatory responses to high doses administered however it
is also an indication of some minor distribution of the compounds to
highly perfused tissues such as the liver. Based on the relatively high
degree of water solubility it is unlikely that members of the AGDS
category will accumulate in body fats and/or breast milk.
effects of nonionic surfactants are of greater importance than systemic
lack of evidence of vomiting and diarrhea is evidence that there is no
direct damage to the mucous membranes of the GI tract. Inhalation
of nonionic surfactants may also be disruptive to pulmonary function due
to direct interaction of the surfactant with surface-active film lining
testing with each member of the AGDS chemical category indicates that
each of the compounds is non-mutagenic and non-clastogenic in tests
conductedin vitroboth with and without the presence of an S9
metabolic activation system isolated from rat liver. In
each assay metabolism by S9 rat liver enzymes did not result in
increased mutation frequency.
environment, all members of the category display stability in water. The
group shows a lack of ready biodegradability but may be
inherently/ultimately biodegradable1. Category
members show a moderate tendency to adsorb to organic carbon, typical of
excretion is likely the major route of elimination of unabsorbed and
unchanged compounds in the AGDS category. Some nonionic surfactants are
known to be resorbed in the large intestine4although this has
not been specifically shown for any member of the AGDS category. If
resorption occurs some elimination of the compound in bile is possible.
of the members of the AGDS category are systemically toxic by the oral,
dermal or inhalation routes in animal studies. Data
suggests low potential for absorption across the skin, gastrointestinal
tract and respiratory tract but suggests the possibility of direct
irritant effects on the mucous membranes of the eyes and upper
respiratory tract. It is likely significant absorption, distribution and
metabolism occurs. Elimination
is likely via the fecal route.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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