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EC number: 932-235-8
CAS number: -
Alchisor TAL 123 is characterized by three constituents: Hydrocarbons
C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol
and dodecan-1-ol. In a conservative approach the most sensitive PNEC
from across the three constituent/constituent categories has been
identified and used to address each endpoint in question. The PNEC
freshwater is based on the PNEC for dodecan-1-ol and is 0.0028 mg/L,
using an AF of 5. The basis of the PNECmarine is the same study for
dodecan-1 -ol with an AF of 50 (PNEC is 0.00028 mg/L). Due to the
paucity of toxicity data for sediment and soil organisms across the
three constituent categories of Alchisor TAL 123 substances, the
PNECwater was extrapolated for undecan-1 -ol and dodecan-1 -ol to
provide indicative PNECs for sediment and soil compartments based on the
underpinning dossiers. PNEC sediment and soil were derived for Alchisor
TAL 123 using the equilibium partitioning method in EUSES for the
purposes of the CSA. As a similar extrapolation was not appropriate for
the C9 -C14 aliphatics, a PNEC for Alchisor TAL 123 is not formally
proposed. Experimental evidence for birds and mammals indicates that
Alchisor TAL 123 and its constituents are unlikely to present a hazard
to birds and a PNECoral is waived.
In summary, it can be seen that Alchisor TAL 123 is characterized by
three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes,
cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol and where data
exist, receptors in the environmental compartment are likely to be most
sensitive to the dodecan-1 -ol constitutent.
After the initial registration, the registrant sought to refine the
approach to provide a more realistic assessment of the environmental
toxicity of the substance. In light of this reassessment and based on
the component results, The registrant proceeded to conduct aquatic
toxicity studies on the two most sensitive trophic levels (Daphnia and
algae) on the substance Alkenes, C11-12, hydroformylation products, low
boiling, EC No 932-235-8 (tradename: Alchisor TAL 123). Results from
these studies for Alchisor TAL 123 were used to determine its
environmental classification under the 2nd ATP to the CLP Regulation.
Complex UVCB substances such as Alchisor TAL 123 are mixtures of
different components (primarily hydrocarbons) exhibiting a variety of
physico-chemical properties. When released in the environment, the
components in these mixtures will behave differently according to their
specific properties (e.g. water solubility, vapour pressure, logKow).
This behavior will define their environmental fate and toxicity. To
address this issue, CONCAWE (the oil producers’ trade organization)
developed the Water Accommodated Fraction (WAF) methodology in the early
1990s. In this methodology, different loadings of the substance are
added to the test medium and equilibrium between the water and the
hydrocarbons is achieved according to their specific water solubility.
The hydrocarbon concentrations at equilibrium will be characteristic of
the loading of the substance, and therefore toxicity values from WAF
studies are expressed as effect loadings or lethal loadings (EL or LL),
not as concentrations. The WAF methodology is widely accepted for the
testing of complex hydrocarbon substances and other UVCBs, and it has
been incorporated in different guidance documents, including the REACH
• CONCAWE report 92/56 (1992): ecotoxicological testing of petroleum
• OECD Series on Testing and Assessment, no. 27 (2001): Guidance
Document on the Use of the Harmonised System for the Classification of
Chemicals which are Hazardous for the Aquatic Environment. Paragraph 71.
• International Maritime Organization GESAMP EHS 28 Document (1993)
Guidelines for aquatic toxicity testing of mixtures containing compounds
of low water solubility.
• REACH endpoint guidance, chapter 7b: considerations for substances
with many components, Table 7-8-3, page 71. The REACH guidance
specifically states “the acute lethal loading level (typically expressed
as the E(L)L50) is comparable to L(E)C50 values determined for pure
substances tested within their solubility range. It may therefore be
used directly for classification.”
• Globally Harmonized System of Classification and Labelling of
Chemicals (GHS), fourth revised edition (2011): Annex 9 (Guidance on
Hazards to the Aquatic Environment), Difficult to test substances. On
page 484, it is stated that “Many substances covered by the
classification scheme are in fact mixtures, for which measurement of
exposure concentrations is difficult, and in some cases impossible.
Substances such as petroleum distillate fractions, polymers, substances
with significant levels of impurities, etc can pose special problems
since the toxic concentration is difficult to define and impossible to
verify. Typical testing procedures often rely on the formation of a
Water Soluble Fraction (WSF) or Water Accommodated Fraction (WAF) and
data are reported in terms of loading rates. These data may be used in
applying the classification criteria.”
• ECHA Guidance on the Application of the CLP Criteria, version 3.0
(2012): Annex I Aquatic Toxicity, section 4.5 on Complex substances. The
REACH guidance specifically states that “complex substances are
characterized by a range of chemical structures, frequently in a
homologous series, but covering a wide range of water solubilities and
other physicochemical characteristics. On addition to water, equilibrium
will be reached between the dissolved and undissolved fractions which
will be characteristic of the loading of the substance. For this reason,
such complex substances are usually tested as a WSF or WAF, and the
L(E)C50 recorded based on the loading or nominal concentrations.
Analytical support data are not normally available since the dissolved
fraction will itself be a complex mixture of components. The toxicity
parameter is sometimes referred to as LL50, related to the lethal
loading level. This loading level from the WSF or WAF may be used
directly in the classification criteria.”
Since Alchisor TAL 123 is a UVCB substance with low solubility, the
aquatic studies were conducted using WAFs as recommended. The results
were 48 hr Daphnia magna EL50 = 43.3 mg/L, 72 hr Pseudokirchneriella
subcapitata EL50 = 14.6 mg/L and 72 hr Pseudokirchneriella subcapitata
NOELR = 3.75 mg/L. These studies indicated that Alchisor TAL 123 is not
toxic to Daphnia or algae at less than 1 mg/L; and we conclude that it
requires no Aquatic Acute Hazard Category classification.
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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