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EC number: 270-302-7
CAS number: 68424-43-1
A fraction of 71% of the substance was degraded in a standard OECD
biodegradation test (Guideline No. 301b)
after 28 days. Although the 10-day window validation criterion was
failed, lanolin fatty acids, as a UVCB, can
be considered as readily biodegradable.
This is supported by calculations done with BIOWIN v4.10 which give no
evidence for persistence (Biowin 2:
probability of rapid biodegradation=0.82; Biowin 3: ultimate
biodegradation timeframe prediction=3.24 weeks).
Therefore, the substance is not considered as P in line with the
screening criteria presented in the REACH
guidance chapter R.11.
Based on the log KOW of 7.73, bioaccumulation can not be excluded. The
EUSES model and the BCFBAF
model included in EPI SuiteTM v4.0 (US EPA, 2009) were used to predict
the bioconcentration factor (BCF).
The predicted BCF differ considerably depending on the used model
(EUSES: 32300 L/kgwwt, BCFBAF: 56.23
However, as a risk management measure and basing on the current
knowledge that lanolin fatty aids and
structurally-related substances are readily biodegradable, long-term
exposure to organisms is unlikely to be
significant, such that the bioaccumulation of lanolin fatty acids in
aquatic organisms is likely to be very
Therefore, based on the fact that lanolin fatty acids are readily
biodegradable, the bioaccumulation property of
lanolin fatty acids may be considered to be of little safety concern.
In the available short-term studies on ecotoxicity no adverse effects
were seen with saturated aqueous solutions.
It is unlikely that a chronic study will reveal adverse effects of the
substance to aqueous organisms. The
substance is not classified as carcinogenic, mutagenic or toxic for
Although no final assessment of the toxicity of the substance can be
made in absence of a long-term study on
marine or freshwater organisms, it is considered unlikely that the
substance fulfils the T-criterion.
Summary and overall Conclusions on PBT or vPvB Properties
The substance is not persistent in the environment and is therefore
neither classified as PBT nor as vPvB.
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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