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EC number: 947-480-6
CAS number: -
No specific toxicokinetic or ADME
investigations, or studies on potential metabolites, were available at
the time of the review. However, physical chemical and
mammalian toxicity data were available for evaluation from which a
reasoned scientific opinion on the ADME parameters of this substance may
be predicted. The data were generated specifically on the registered
substance inGLP and regulatory compliant studies.An on-line literature
(primarily PubChem, TOXNET, ChemIDplus) search did not reveal any
further data that might aid in this prediction.
The test material was very poorly soluble
in water (1.61 x 10E-02 gTOC/L) and had a partition coefficient (Log10
Pow) of 4.15 (anionic components) and 4.94 (cationic components),
indicating a lipophilic substance. The flash point
(143 ± 2 °C), boiling point (partial boiling, approximately 75%, from
about 227 °C) and pour point (-9 ± 3 °C) would not suggest that this
substance would present a risk of inhalation exposure under ambient
environmental conditions. Moreover, the surface
tension was 48.1 mN/m, and the substance was considered to be surface
The lipophilicity of the test material
indicates that it would be readily absorbed across the lipid bilayers of
cell membranes, after oral exposure and this may have been aided using
the vehicle for oral gavage dosing. The lack of
toxicity seen in the either the acute oral or dermal studies does not
preclude acute oral or dermal absorption. The systemic
toxicity observed in the 28-day repeat oral toxicity
reproductive/developmental toxicity screening study clearly demonstrated
the oral absorption and bioavailability of test item.
The substance would be expected to be
widely distributed particularly in the liver and kidneys as revealed by
the liver and kidney effects after repeated oral dosing. The
data overall would not suggest significant bioaccumulation as
illustrated by the recovery phase in the repeat dose study. The physical
nature of the test item and physical chemistry data suggest that it is
unlikely that acute inhalation exposure (not expected to present an
exposure risk) would result in toxicity considering the very low
toxicity evident in the acute studies presented.
It is expected, from the both the physical
chemistry and toxicity data, that metabolism would be primarily via the
liver and secondarily the kidneys. At 500 mg/kg bw/day in the repeat
dose toxicity study, particularly in the male rats, the liver weights
were increased, which is a sensitive indication of hepatocellular
microsomal enzyme induction. Therefore, the substance is likely to be
extensively metabolised in the liver. In the
genotoxicity studies no genotoxicity was seen either with or without the
addition of metabolic activation (+/- liver S9-mix), this support the
view that potential metabolites that may be of limited mammalian
Given the physical chemical properties of
the substance, the nature of the effects seen in the repeat dose
toxicity study (increased liver and kidney weight; enhanced hepatic
metabolism) and possibly limited bioaccumulation, it is predicted that
excretion would be primarily via the urine and faeces.
The physical chemical characteristics of
the registered substance plus data from the repeat dose toxicity study
clearly suggest and demonstrate that the test item is likely to be
rapidly absorbed, distributed and excreted with limited bioaccumulation.
The substance was not acutely toxic via oral and dermal routes and not a
sensitiser, although causing serious damage to eyes and irritating to
skin. The data suggest that the liver is a target organ and that
enhanced metabolism is likely to occur, although the toxicity of
metabolites is likely to be limited as in the genotoxicity studies
metabolic activation was without demonstrable effect. Considering
these attributes, the most likely route of excretion would be primarily
via the urine and secondarily the faeces.
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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