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EC number: 203-367-7
CAS number: 106-15-0
effects in the environment:
(CAS no. 106-15-0) is used as an pharmaceutical intermediate. The
aim was to assess whether the PBT criterion within Annex XIII was
fulfilled for12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide. The PBT
criterion was herein assessed based on experimental data in conjunction
with standardized environmental fate models. Here follows a description
of the PBT assessment.
The tested substance does not
fulfil the P criterion within Annex XIII based on the assessment that
Estimation Programs Interface Suite
(EPI suite, 2018) was run to predict the biodegradation potential of the
test compound 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide (CAS
no. 106 -15 -0) in the presence of mixed populations of environmental
microorganisms. The biodegradability of the substance was calculated
using seven different models such as Linear Model, Non-Linear Model,
Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe,
MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as
Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results
indicate that chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide is
expected to be readily biodegradable.
Experimental result from the read
across substance also indicate that they are readily biodegradable.
Thus, based on the available
information, it indicates thatchemical12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amidecan
be considered to be readily biodegradable in water and thus likely to be
not persistent (Not P) in nature
According to the fugacity model levels
III, the most likely environmental fate for this test chemical is soil (i.e.estimated
to 77.2%). In soil,12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amidewas
expected to have moderate mobility based upon a Log KOC value of 1.801±
0.001at 25°C. The half-life in soil (30 days estimated by EPI suite)
indicates that the chemical is not persistent in soil and the exposure
risk to soil dwelling animals is moderate to low.
If released in to the environment,
21.9% of the chemical will partition into water according to the Mackay
fugacity model level III in EPI suite version 4.1 (2017). However, the
half-life (15 days estimated by EPI suite) indicates that the chemical
is not persistent in water and the exposure risk to aquatic animals is
moderate to low.
Moreover, its persistent
characteristic is only observed in the sediment compartment but Fugacity
modelling shows that sediment is not an important environmental fate
(less than 1% i.e reported as 0.545% when estimated by EPI Suite version
Hence it has been concluded thatchemical12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amideis
not persistent (not P) in nature.
The tested substance fulfils the B
criterion within Annex XIII based on the assessment that here follows:
Theoctanol water partition coefficient
of the test chemical was estimated to be 5.021± 0.012 at 25°C as per
OECD TG 117. Since the logKow value goes to greater than the threshold
of 4.5. If this chemical is released into the aquatic environment, there
should be a high risk for the chemical to bioaccumulate in fish and food
The tested substance does not
fulfil the T criterion within Annex XIII based on the assessment that
The tested chemical is regarded to be
not classified for carcinogenicity, mutagenicity and reprotoxicity,
Further, there is no evidence of chronic toxicity, as identified by the
classifications STOT (repeated exposure), category 1(oral, dermal,
inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2
(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).
On the basis of the various
experimental studies of the structurally and functionally similar read
across chemical (including the biodegradability of read across chemical)
and applying the weight of evidence approach,the LC50/EC50 value for fishof
the test chemical12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amidecan be
determined to be >15 mg/L, respectively and all of the available
short-term eco-toxicity data for aq. invertebrates and algae for the
test chemicalindicates the LC50/EC50 value to be > 100 mg/L. These value
suggest that the substance is likely to be not hazardous to aquatic
organisms at environmentally relevant concentrations andhence,
considered to be ‘not classified’as per the CLP regulation.
There are no available long-term
toxicity evaluations for12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide.
By speculation, long-term NOEC for aquatic organisms were not expected
for the substance at concentration below 0.01 mg/L based on the data
The chemical was therefore not
considered as hazardous to aquatic environments as per the criteria set
out in Annex XIII.
Based on critical, independent and
collective evaluation of information summarized herein, the tested
compound fulfils the B criterion, but does not fulfil the P and T
criterion and hence, therefore not been classified as a PBT compound
within Annex XIII.
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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