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EC number: 417-070-7
CAS number: 151006-62-1
1-DODECENE TRIMER, HYDROGENATED; ALKANE 4
The criteria set out under
REACH for determining whether a substance is PBT/vPvB are as follows:
Half-life (T½) > 60 d in marine water or
Half-life (T½) > 40 d in fresh or estuarine water or
Half-life (T½) > 180 d in marine sediment or Half-life (T½) > 120 d in fresh or estuarine water; sediment or
Half-life (T½) in soil > 120 d
Half-life (T½) > 60 d in marine fresh or estuarine water or
Half-life (T½) > 180 d in marine, fresh or estuarine water; sediment
Half-life (T½) > 180 d in soil
BCF > 2000 L/kg in fresh or marine aquatic species
BCF > 5000 L/kg
Chronic NOEC < 0.01 mg/l for marine or freshwater organisms, or
Substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) or
There is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
Note: (a) BCF is bioconcentration factor, NOEC is no-observed effect concentration and CMR is a substance classified as carcinogenic, mutagenic or toxic for reproduction
(b) For marine environmental risk assessment, half-life data in freshwater sediment can be overruled by data obtained under marine conditions
(c) Substances are classified when they fulfil the criteria for all three inherent properties for P, B and T. However, there is certain flexibility, for instance in cases where one criterion is marginally not fulfilled but the others are exceeded considerably.
The above criteria are the
definitive criteria for PBT assessment and listed in Annex XIII of
REACH. However, the first step in the PBT assessment is to conduct a
screening assessment using screening criteria. Once this screening step
is carried out it is possible to evaluate measured data against the
definitive criteria listed above. If a substance is confirmed to be
PBT/vPvB a third step is required to estimate the amounts of substance
released to the different environmental compartments from all activities
One of the screening
criteria for persistence is that if a substance is not considered to be
readily biodegradable then the substance is screened as being P and vP.
Biodegradation screening studies are available for a number of
substances in Category E, these being 68037-01-4 (Douglas, 1993;
Bianchini-Akbeg, 1991), 68649-11-6 (Douglas, 1993; McGoldrick and Mehta,
1992), 151006-58-5 (Douglas and Sewell, 1989; Handley and Mead, 1995),
68649-12-7 (Mehta and McGoldrick, 1992; Handley and Mead, 2005; Mead,
2005), 151006-60-9 (Handley and Mead, 1995) and 883233-93-0 (Hamwijk,
Hanstveit and Verweij, 2002a and 2002b) and all have found the test
substance not to be readily biodegradable. Based on read across from
this data, the rest of the substances in this category are also
considered not to be readily biodegradable.
Therefore, based on the
screening criteria for persistence stipulated in the ECHA’s Guidance on
Information Requirements and Chemical Safety Assessment - Part C: PBT
Assessment (2008) substances in this category are considered persistent
(P) and potentially very persistent (vP).
The screening criterion for
bioaccumulation is that a substance is potentially B or vB if it has a
log Kow of >4.5. Experimental data on Kow are available for members of
this category. For 68649-11-6 log Kow is measured as >6.5 (Walker and
Mullee, 2006) and >4.82 (Hogg and Bartlett, 1995). For 68649-12-7,
experimental data measures log Kow as >5 (Howard, 1982), >7.6 (Seary,
2000) and >3.87 (Hogg and Bartlett, 1995). For 68037-01-4 an
experimental value of >6.5 (Walker and Mullee, 2006) is given. As the
majority of the experimental log Kow for substances in this category are
greater than 4.5 this indicates that they meet the screening criteria
for bioaccumulation stipulated in the ECHA’s Guidance on Information
Requirements and Chemical Safety Assessment - Part C: PBT Assessment
(2008) and therefore cannot be ruled out as being B or vB.
ECHA’s Guidance on
Information Requirements and Chemical Safety Assessment - Part C: PBT
Assessment (2008) states that the aquatic BCF of a substance is probably
lower than 2000 L/kg if the calculated log Kow is higher than 10. All of
the experimental log Kow values for substances in this category are
unbounded due to limitations of the experimental method, so do not allow
us to conclude if the log Kow is greater than 10. Calculated partition
coefficients have been obtained from EPIWEB 4.0 (USEPA, 2008) and SPARC
(Karickhoff et al, 2009) for dec-1-ene dimer, hydrogenated (CAS
68649-11-6) and dec-1-ene trimer, hydrogenated (CAS 157707-86-3) as
these are the only two members of this category being registered as
substances with predominantly a single carbon number. The calculated log
Kow for 68649-11-6 is 10.09 and 11.71 and for 157707-86-3 is 14.93 and
17.21 (USEPA, 2008 and Karickhoff et al, 2009 respectively). All of the
calculated log Kow values are greater than 10.
There is a clear trend of
increasing log Kow with increasing carbon number in the alkanes and
olefins. 68649-11-6 is the category member with the lowest carbon
number, and therefore will be the category member with the lowest
partition coefficient. This therefore indicates that the calculated log
Kow of all category members would be >10. As QSAR models do not have
experimental data in this Kow range the reliability of modelled Kow
values >10 is not known. However, as the model indicates a log Kow >10
for the category member with the lowest carbon number we can conclude
that members of this category are unlikely to meet the definitive
criteria for B/vB.
A measured BCF is not
currently available for members of this category so data cannot be
compared to the definitive criteria given in REACH Annex XIII. However,
on the basis of the calculated log Kow for two category members this
category is not considered as bioaccumulative (B) or very
The screening criteria for
toxicity are that an acute EC50 or LC50 <0.1mg/l is considered to be T,
and that an EC50 or LC50 <0.01mg/l indicates that the substance is
There is acute aquatic
toxicity data available for a number of substances in this category. The
EL50 and LL50 values measured for these substances are considered to be
suitable for read across to the rest of this category. Acute ecotoxicity
studies are available for invertebrates, algae and fish. Due to the very
low solubility of the category members all of the results are expressed
as Water Accommodated Fractions (WAF). All report the EL or LL50 were
greater than the highest concentration tested. As these studies report
results as WAF they cannot be compared directly with the screening
criteria for toxicity. However, they do indicate that the poly alpha
olefins in this category are not acutely toxic at their limits of
The toxicity of the poly
alpha olefins in this category has been predicted using the PETROTOX
3.01 model. PETROTOX indicates that branched and linear alkanes and
alkenes with a carbon number equal to or greater than C14 will not exert
any toxicity at concentrations up to their limit of solubility. The
components of the substances in this category have carbon numbers equal
to or greater than C20. PETROTOX therefore predicts that toxicity will
not be observed at concentrations up to the limit of solubility.
Therefore, based on the
weight of evidence category members are considered not T for the
purposes of the PBT assessment.
Poly alpha olefins do not
fulfill the toxicity criterion for human health based on the evidence
Toxicity. No developmental or 2-generation reproductive toxicity data
are available for poly alpha olefins. However
two one-generation reproduction toxicity studies from 1 -decene,
homopolymer, hydrogenated and another from a structural analogue, Alkane
4, showed no effect on reproductive or developmental parameters. There
were no relevant human studies identified. Data
on all other toxicological endpoints for PAOs show low toxicological
activity, including an absence of effects on reproductive endpoints.
Repeat dose studies up to 90 days did not identify any adverse effects
on reproductive organs. Collectively,
these data suggest that poly alpha olefins are unlikely to be
reproductive toxins; therefore further testing is not warranted.
screening assessment of the available data for this category indicates
that conclusion (ii) is appropriate for this substance as stipulated
The data show that the properties of the substance do not meet the
specific criteria detailed in Annex XIII or do not allow a direct
comparison with all the criteria in Annex XIII but nevertheless indicate
that the substance would not have these properties and the substance is
not considered a PBT/vPvB.
Therefore the PBT/vPvB
assessment stops at this point.
This section of the report
is not required for non PBT/vPvB substances.
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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