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EC number: 601-409-2
CAS number: 116020-44-1
The acute toxicity of the test item was investigated in an acute
toxicity study on rats. The test animals showed no clinical signs (and
no mortality) up to the limit dose after oral administration. Hence, the
LD50 is above 2000 mg/Kg bw.
The subsequent evaluation on the necessity of a acute test via a second
route was done in accordance with Guidance on Information Requirements
and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance,
Version 6.0, July 2017, p 374f.
A DermWin calculation shows a dermally absorbed dose of 1*10 -5 to 8.7
-10 -5 mg/cm2/event. Based on the very low dermally absorbed rate and
the absence of systemic effects after acute oral administration, a study
on acute dermal toxicity is not required.
Furthermore, based on the lack of systemic toxicity after acute oral
adminsitration, it is more than evident that an acute study on
inhalation would not show any different outcome. Therefore, and due to
animal welfare reasons a study on acute inhalation is not required.
Justification for selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied
are fully compliant with OECD TG 423.
Justification for selection of acute toxicity – dermal endpoint
On 15 July 2014 the Competent Authorities for REACH and CLP
(Caracal) have agreed that substances that are not toxic in acute oral
tests need no longer be tested for acute dermal toxicity. Caracal agreed
on proposals to amend REACH Annex VIII (point 8.5.3) so that substances
that have not shown oral acute toxicity up to a limit dose of 2000mg/kg
bodyweight would not also require dermal data. The test material does
not provide evidence for acute oral toxicity. The LD50 exceeds 2000
mg/kg bw. Therefore no further testing for dermal toxicity is justified.
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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