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EC number: -
CAS number: -
The water solubility of Corsair Clear #12 is
very low (<0.282 mg/L). Since in general a substance needs to be
dissolved before it can be taken up from the gastro-intestinal tract, it
is unlikely that Corsair Clear #12 will show a high systemic exposure
after oral administration. The absorption will furthermore be lowered by
the relatively large molecular weight of this substance (1763-2891),
limiting the passage through biological membranes. Its highly lipophilic
character (logPow > 6.5) indicates that uptake by micellular
solubilisation may be of particular importance. For risk assessment
purposes the oral absorption of Corsair Clear #12 is set at 10%. The
results of the toxicity studies do not provide reasons to deviate from
this proposed oral absorption factor. The anticipated cleavage of
Corsair Clear #12 in the gastro-intestinal tract (see below) however
results in molecules with different physical/chemical characteristics.
The proposed 10% oral absorption may thus not be applicable for these
breakdown products; moreover, based on the reduced molecular weight and
the anticipated higher polarity, the oral absorption of some of these
molecules might be above 10%.
In the gastro-intestinal tract the molecule
might undergo breakdown (cleavage of amide-bond amidases, hydrolysis of
ester). Absorbed Corsair Clear #12 might be subject to Phase I and Phase
II reactions (1). Distribution through the body will be limited due to
the low water solubility and the high molecular weight. Because of the
high molecular weight, the conjugates will predominantly be excreted via
Based on its physical form (soft waxy beige
solid) and very low vapour pressure (1.38 x 10-6 Pa – 3.49 x 10-5 Pa) it
is not to be expected that this substance will reach the nasopharyngeal
region or subsequently the tracheobronchial or pulmonary region. If
however any Corsair Clear #12 is inhaled, its very low water solubility
(<0.282 mg/L) indicates a potential for accumulation, while its
lipophilic character (logPow > 6.5) indicates the potential for
absorption directly across the respiratory tract epithelium. Although it
is unlikely that Corsair Clear #12 will be absorbed to a high extent
after inhalation via the lungs, for risk assessment purposes the
inhalation absorption of Corsair Clear #12 is set at 100% as a worst
Corsair Clear #12 being a solid with a high
molecular weight (1763-2891) has no real potential for dermal
absorption. Furthermore, its low water solubility and highly lipophilic
character do not facilitate dermal absorption. As the criteria for 10%
dermal absorption as given in the TGD (2) (MW > 500 and logPow > 4) are
met, 10% dermal absorption of Corsair Clear #12 is proposed for risk
assessment purposes. The results of the toxicity studies do not provide
reasons to deviate from this proposed dermal absorption factor.
Based on the present available data, no
additional conclusions can be drawn on the distribution, metabolism and
excretion of Corsair Clear #12 after dermal and inhalatory absorption.
1. A. Parkinson. In: Casarett and Doull’s
Toxicology, The basic science of poisons. Sixth edition. Ed. C.D.
Klaassen. Chapter 6: Biotransformation of xenobiotics. McGraw-Hill, New
2. ECB EU Technical Guidance Document on
Risk Assessment, 2003.
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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