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EC number: 204-101-2
CAS number: 115-70-8
Based on all available data of the substances within the chemical category, the weight of evidence demonstrates that the substances in this chemical category seem highly unlikely to be carcinogenic and are not classifiable as carcinogens. Further testing is not required under Regulation (EC) 1907/2006, Annex XI, section 1.2.
Based on all available data
of the substances within the chemical category, it
is expected that AEPD has no carcinogenic potential. The
available data do not meet the criteria for classification according to
Regulation (EC) 1272/2008 or Directive 67/548/EEC, and
are therefore conclusive but not sufficient for classification.
There are no animal data available on the carcinogenicity or
chronic toxicity of 2-amino-2-ethyl-1,3-propanediol (AEPD) or within the
chemical category AEPD belongs to. The members of the category of
2-amino-1,3- propane-diols are substances that share a common propane
backbone with an amine group at 2-carbon position and primary alcohols
at 1 and 3 positions. The following substances are thus members of the
aminopropanediol category: 2-amino-2-ethyl-1,3-propanediol (AEPD, CAS
No. 115-70-8), 2-amino-2-methyl-1,3-propane-diol (AMPD, CAS No.
115-69-5), 2-amino-1,3-propanediol (APD, CAS No. 534-03-2) and
2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol, CAS No.
77-86-1) The only structural difference between trometamol and AEPD is a
replacement of a hydroxyl group with a methyl group. Further analogues
differ in the length of the alkyl side-chain at position 2 so that the
following sequence is obtained: from 0 carbon atoms (APD) through 1
(AMPD) to 2 (AEPD). There are no other functional groups present in
The modelling of potential metabolites via the OECD QSAR toolbox
v.2.0 (2010) did not predict relevant metabolites of the category
members. Based on the chemical structure of the parental compounds, no
metabolism is expected. Therefore, it can be assumed that
aminopropanediols will not show reactive properties under in vitro and
in vivo test conditions. All the category members are of low
concern with regard to systemic toxicity. Available studies via the
oral, dermal and intraperitoneal route indicate low acute and repeated
dose toxicity. Inhalation is of no concern, because the low vapour
pressure means that exposure is unlikely to occur. The results of the
acute studies, as well as the repeated dose studies, demonstrate that
the main cause of toxicity was the intrinsic alkalinity of the category
members at the site of contact. The Cramer classification (related
mainly to the oral route) also indicates a low toxicological concern for
all the category members. No metabolism by cytochrome P450 enzymes
in-vivo is expected; this is supported by predictions from QSAR
modelling. Furthermore, all the category members were not mutagenic or
clastogenic in the available genetic toxicity studies, bear no
structural similarity to known carcinogens, have no functional groups
associated with carcinogenicity and did not produce evidence of
neoplasia in repeated dose toxicity studies. Therefore it is concluded
that the category members do not possess a carcinogenic potential.
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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