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EC number: 423-300-7
CAS number: 128554-52-9
The available information suggests limited absorption of the substance from the gastrointestinal tract following oral administration can occur. Dermal absorption is expected to be very limited. Once absorbed the substance may accumulate in fatty tissues. There is limited evidence of the metabolism of the substance, although hydrolysis may occur. Biliary excretion may well be the significant route of excretion for the substance.
The substance is a UVCB. It is an off white solid powder and the
molecular weight ranges from 300 - 982 g/mol. The low vapour pressure
value (2.6 x 10-6 Pa) and predicted negative explosive and
oxidising properties shows that the substance is not volatile. However,
the median particle size is relatively small at 1.97 µm. The substance
has a high log octanol/water partition coefficient value (log Pow >6.5)
and low water solubility (<0.64 mg/l based on comparable substance).
The acute toxicity tests (based on a comparable substance) showed that
the LD50 of the substance was greater than 2000 mg/kg bw after oral
administration and dermal application. The LC50 in an acute inhalation
study was >5.08 mg/L air. The substance is not classified for acute
A sub-acute 28-day study (based on a comparable substance gave a NOAEL
of 200 mg/kg bw/day. A sub-chronic 90-day study (based on a comparable
substance) gave a NOAEL of 250 mg/kg bw/day. A pre-natal developmental
study (based on a comparable substance) gave a NOAEL of 1000 mg/kg
The substance is not a skin or eye irritant, but is a skin sensitiser
(based on a comparable substance).
The substance is non-mutagenic in bacteria, non-clastogenic in mammalian
cells in vitro and non-mutagenic in mammalian cells in vitro (based
on studies on comparable substances).
As the water solubility of the test substance is very low, this may be
considered as a rate-limiting factor for the absorption of the
substance. Results of the acute oral study and repeat dose studies
(28-day) showed limited evidence to support the gastric absorption of
the substance. This would be supported by the lipophilic nature of the
substance (log Pow >6.5). The gastro-intestinal tract may provide a
limited route of absorption following oral administration.
Absorption via the skin is expected to be very limited due to the
molecular weight, log Pow and low water solubility. No signs of systemic
toxicity or local irritation were observed in acute dermal and skin
The low vapour pressure of the substance (2.6 x 10-6 Pa)
indicates that the substance is not readily available for inhalation,
although the small median particle size of 1.97 µm could result in
potential uptake of the substance during inhalation exposure.
If absorbed, hydrolysis of the amide bonds may occur.
Significant systemic distribution was not evident from the repeat dose
studies (28 -day, 90 -day and pre-natal developmental toxicity).
The positive response in a skin sensitisation study suggests the
substance may bind to carrier proteins in the circulatory system,
potentially facilitating distribution.
Once absorbed, the substance may potentially accumulate in fatty tissues
due to the high log octanol/water partition coefficient (log Pow >6.5)
and low water solubility.
The results of the repeat dose studies did not show evidence to indicate
any substance influenced hepatic metabolism. the results of the
genotoxicity assays have shown that gentoxicity is neither enhanced or
diminished in the presence of metabolic activation.
Hydrolysis of amine bonds is possible in the liver.
There is no evidence to indicate the route of excretion but poorly water
soluble substances are not favourable for urinary excretion. Therefore,
biliary excretion may well be a significant route for this substance.
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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