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EC number: 224-809-5
CAS number: 4500-29-2
In an enhanced OECD301B study the registration substance (17 mg/L;
10.8 mg C/L) reached the required level of 60% degradation within 43
days, the substance is therefore ultimately biodegradable using a
non-adapted municipal activated sludge. Continuous degradation could be
observed starting at day 6 reaching a maximum of 91% degradation on day
60. The only enhancement was the prolongation to 60 days.
Degradation of the registration substance in soil and sediment is
likely. No stable metabolites are expected based on degradation pathway
modeling. Cyclohexylamine, which is an important metabolite is assessed
to be readily biodegradable during CoRAP process of the substance.
Therefore, it can be concluded that the substance is not P and not
The registration substance has a low potential for uptake into the
organism independent if the driving mechanism is hydrophobicity (log
Kow=1.57, calculated BCF < 12 L/kg) or includes an ionic mechanism
(logkplip-w < 2.35, conservatively derived from C8-alkyl-dimethyl amine).
It is very unlikely that the ionic registration substance would
pass biological membranes.
For similar substances (C9-alkyl-dimethyl amine and
C10-alkyl-dimethyl amine), within the ECO37 project fast
biotransformation has been shown with measured in-vitro clearance rates
(CLS9 of around 300 ml/h/g liver) and an in-vivo bioaccumulation
experiment indicated low potential to bioaccumulate (Uptake rate (K1) =
2.2 L/kg.h; Elimination rate (K2) = 0.057 1/h; BCFkinetic = 40 L/kg).
All similar substances have longer alkyl-chains than the registration
substance, and in all cases the values increase with increasing
alkyl-chain-length. Therefore, all values can be seen as worst-case
conservative approach. (Further details can be found in IUCLID Chapter
In conclusion the substance has a low bioaccumulation potential
and is not B and not vB.
The available acute and chronic aquatic ecotoxicty data of registration
substance are all > 1mg/L. In addition the registration substance is not
classified as carcinogenic, mutagenic or reprotoxic as given in the
Criteria for the PBT / vPvB Assessment. But the registration substance
is classified under DSD 67/548/EEC as Xn, R48 and under 1272/2008/EC as
having a specific target organ toxicity after repeated exposure (STOT RE
category 2). This means the 'T' criteria for the PBT / vPvB Assessment
The registration substance fulfilles the Crititera 'T' but not the 'P'
or 'B' criteria relevant for the PBT Assessment under REACH. The overall
result is therefore: The registration substance is not PBT/vPvB
according the criteria for the PBT Assessment under REACH.
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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