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EC number: 700-425-8
CAS number: 521284-22-0
Only standard information required at REACH Annex VIII is available for assessing the toxicokinetics for the test substance. The available test data do not permit conclusions concerning absorption, metabolism or excretion to be drawn conclusively. The test substance data requires that the test substance be classified for acute toxicity effects via the oral and inhalation routes and the effects observed in these studies and in the repeated dose and developmental screening test indicate that absorption and distribution of the test material in vivo is likely to occur.
The available test data do not permit conclusions concerning absorption,
metabolism or excretion to be drawn. In the acute oral study, high
mortality was observed at 300 and 2000 mg/kg with no mortality observed
at 50 mg/kg (although adverse clinical signs were noted at this dose).
In the acute inhalation study, at ca. 7 mg/L high mortality was observed
with no mortality observed at ca. 1 mg/L.
In the combined repeated dose and developmental screening assay (OECD
422 study), there was no test substance related mortality, but findings
included clinical signs, lower motor activity in conjunction with low
bodyweight gain and food consumption. These findings were observed at
all doses on study (although to a less significant degree at the lower
dose). The clinical signs observed were reversible after a period post
These study findings potentially indicate that the test substance is
absorbed via oral and inhalation exposure and distributed systemically.
The reversibility of clinical signs seen in the repeated dose study
indicates that the test substance could be rapidly eliminated by normal
metabolic and excretory mechanisms.
No reproductive toxicity was observed at any dose tested indicating
either low absorption to the relevant tissues involved or low general
tissue toxicity. With regards to developmental effects, mean pup
bodyweight at 25 and 50 mg/kg was reduced compared with controls, and
given the magnitude of the lower pup bodyweight gain was considered to
be adverse. This finding is most likely attributed to parental toxicity,
as the lowest mean pup body weight gain per litter was noted for dams
that showed weight loss during lactation. On Day 1 of lactation there
were also no statistically significant differences in pup bodyweights at
all doses compared with controls.
The substance was determined to be a skin sensitiser based on the
results of a LLNA, indicating that the test substance potentially has
the ability to pass through the dermal layers of the skin, and can
induce proliferation of lymphocytes in the relevant draining lymph nodes.
There were no positive findings in any of the in vitro genotoxicity
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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