Registration Dossier
Registration Dossier
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EC number: 241-640-2 | CAS number: 17661-50-6
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available investigating the aquatic toxicity oftetradecyl stearate (CAS 17661-50-6). In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
The source substancesdodecyl oleate(CAS 36078-10-1) and(Z)-octadec-9-enyl oleate (CAS 3687-45-4) are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances is used to predict the same endpoints for tetradecyl stearate (CAS 17661-50-6).The target substance is an ester of a linear C16-C18 fatty acid esterified with a linear C14 alcohol. Dodecyl oleate(CAS 36078-10-1)is characterized by a C18 unsaturated fatty acid esterified with a linear C12 alcohol. (Z)-octadec-9-enyl oleate(CAS 3687-45-4)is a mono-constituent substance characterized by a linear C18 unsaturated fatty acid esterified with a linear C18 unsaturated alcohol.A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
All available experimental data on the source substances performed
according to internationally accepted guidelines indicate no evidence of
acute and chronic toxicity to aquatic organisms. Data for all three
trophic levels are available. No toxicity was observed up to the limit
of water solubility in all available experimental studies. The water
solubility of the target substance was determined to be 0.5-1 µg/L at 20
°C, pH 6.
The
short-term toxicity to fish was determined in a standard OECD guideline
study from a suitable read-across substance. No mortality was observed
after 96 h resulting in a LL50 > 100 mg/L (i.e. above the water
solubility limit). The same was recorded for the toxicity to aquatic
algae. No inhibition of growth of aquatic algae was observed in an
experimental study according to OECD 201 up to the limit of water
solubility. Due to the low water solubility, long-term testing to
aquatic invertebrates was considered to be necessary to assess the
aquatic toxicity. The available studies performed with suitable source
substances resulted in a NOELR/NOEC (21 d) ≥ 100 mg/L indicating no
effects on reproduction up to the limit of water solubility. Long-term
toxicity testing to fish was not considered to be necessary since there
was no evidence from the available data that fish are more sensitive
compared to aquatic invertebrates. No toxicity to fish was observed in
the available acute tests. Thus, in order to avoid unnecessary
vertebrate testing, no long-term testing with fish was proposed.
The degradation process in commercial sewage treatment plants is not
suspected to be inhibited by the target substance. One available study
performed with activated sludge from a sewage treatment plant did not
indicate a risk since respiration of activated sludge microorganisms was
not inhibited.
Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that tetradecyl stearate exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substances support the read-across by showing a consistent pattern of results.
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.
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