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EC number: 239-622-4
CAS number: 15571-58-1
The results of the previous hydrolysis study (Anonymous 2000) which were considered to support the use of the substance DOTC as an appropriate surrogate for mammalian toxicology studies of the corresponding thioesters, DOTE and its close analogue DOTI, when dosed via the oral route are now considered by the registrant to have been recently superceded by the findings of a more modern study. Further information on teh potential for absorption of the material was available in teh form of Ward, 2003 a study on the in vitro absorption of the substnace through the skin.
absorption of DOT(2 -EHMA) was measured in vitro (Ward 2003) through
both occluded and unoccluded human and rat epidermis. The absorption
through rat epidermis was much faster than through human epidermis:
EPIDERMIS: A dose of 17,007 ug tin/cm2 was determined to alter the
barrier function of the epidermis. From the occluded and unoccluded
applications, the rates of tin absorption over the 0-24 h exposure
period were below the limit of quantification (0.001 ug/cm2/h). In terms
of percent applied tin, 0.0001% was absorbed from the occluded dose, and
0.0001% was absorbed from the unoccluded dose after 24 hours of exposure.
EPIDERMIS: Absorption of tin through rat epidermis was much faster than
through human epidermis. From the occluded application, the maximum rate
of tin absorption (0.035 ug/cm2/h) occurred during 16-24 hours of
exposure, and the mean rate of tin absorption over the whole 24-h
exposure period was 0.021 ug/cm2/h. From the unoccluded application, the
maximum rate of tin absorption occurred during 12-24 hours of exposure
and was 0.033 ug/cm2/h. The mean rate of tin absorption over the whole
24-h exposure period was 0.025 ug/cm2/h. In terms of percent applied
tin, 0.003% was absorbed from the occluded dose, and 0.004% was absorbed
from the unoccluded dose after 24 hours of exposure. The overall
recovery of tin from the test system after 24-h exposure was low and may
be due to adsorption of the test substance to the glass equipment used.
The recovery was 45.5% (human) and 25.2% (rat) of the applied occluded
doses, and 29.6% (human) and 30.5% (rat) were recovered from the
unoccluded test systems. Of the recovered tin, 2.1% (human) and 5.5%
(rat) were obtained from the surface of the epidermis and donor chamber.
The mean amounts of tin absorbed by 24 hours were 0.010 ug/cm2
(unoccluded) and 0.011 ug/cm2 (occluded) through human epidermis and
0.641 ug/cm2 (unoccluded) and 0.547ug/cm2 (occluded) through rat
results show that the absorption of tin from dioctyltin
bis(2-ethylhexylmercaptoacetate) through rat epidermis significantly
overestimated absorption from human epidermis. By 24 hours only a small
amount of the applied tin (3% in human and 1% in the rat) is associated
with the epidermis and is not regarded as systemically available.
molecule of this size would typically be considered to have a somewhat
limited distribution and there is the potential for preferential
partition to fatty/adipose tissues upon repeated exposure given the high
log Pow and extremely low predicted water solubility of the material.
vitro toxicokinetics studies under simulated mammalian gastric
conditions, using 119-Sn-NMR to identify the reaction products, clearly
show Dioctyltinchlor 2-ethylhexymercaptoacetate (DOTCE) is the only
identifiable hydrolysis product. No DOTC could be detected under the
conditions of the studies (Naßhan H 2014, Naßhan H 2015)
molecular weight of >300 indicates that excretion is more likely to
occur via the bile.
of 100%, 0.004% and 100% are adopted for oral, dermal and inhalation
exposure in accordance with ECHA guidance and the results of the studies
within the body would be considered to be somewhat limited by the
relatively large molecular weight of the substance with preferential
partitioning to fatty tissues.
simulated gastric hydrolysis study indicates that the substance would
likely form its monochloride form following substitution of one (but not
both) of the thioester side chains. The molecular weight of >300
suggests elimination via the bile.
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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