Registration Dossier
Registration Dossier
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EC number: 469-110-8 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
AD- 1000 consists of three known
compounds. As no detailed information on the "other unknown
bisamides" (7.3%) is available, these impurities are
excluded from the conclusions drawn.
The water solubility of AD-1000 is very low (<0.0007 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 AD-1000 will show a high systemic exposure
after oral administration. The absorption will furthermore
be lowered by the relatively large molecular weight of this
substance and the presence of potentially ionisable groups,
limiting the passage through biological membranes. Its
highly lipophylic character (logPow > 6.5) indicates that
uptake by micellular solubilisation may be of particular
importance. For risk assessment purposes the oral absorption
of AD-1000 is set at 10%. The results of the toxicity
studies do not provide reasons to deviate from this proposed
oral absorption factor.
In the gastro-intestinal tract the amide-bond might be
cleaved by amidases. Absorbed AD-1000 might undergo
conjugation. Because of the reduced molecular weight
after cleaving the amide-bond, the conjugates will either be
excreted via the bile or the urine.
Based on the particle size of the AD-1000, particles will
either settle in the nasopharyngeal region (particles with
aerodynamic diameter > 1-5 µm) or in the tracheobronchial or
pulmonary region (particles with aerodynamic diameter < 1-5
µm). The very low water solubility of AD-1000 indicates a
potential for accumulation, while its lipophilic character
(log Pow > 6.5) indicates the potential for absorption
directly across the respiratory tract epithelium. Although
it is unlikely that AD-1000 will be absorbed to a high
extent after inhalation via the lungs, for risk assessment
purposes the inhalation absorption of AD-1000 is set at 100%
as a worst case assumption.
AD-1000 being a solid with a relatively high molecular
weight has no real potential for dermal absorption.
Furthermore, its low water solubility and highly lipophylic
character do not facilitate dermal absorption. As the
criteria for 10% dermal absorption as given in the REACH Guidance on
information requirements and chemical safety assessment
(MW > 500 and logPow > 4) are met, 10% dermal absorption of
AD-1000 is proposed for risk assessment purposes. The
results of the toxicity studies do not provide reasons to
deviate from this proposed dermal absorption factor.
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.
