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EC number: 701-203-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
In order to fulfil the standard information requirements a read-across from three structurally related substances was conducted in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. 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.
Ecotoxicological parameters for the aquatic toxicity of the target and the source substances are presented in the following table.
ID |
CAS |
Short-term toxicity to fish |
Long-term toxicity to fish |
Short-term toxicity to aquatic invertebrates |
Long-term toxicity to aquatic invertebrates |
Toxicity to aquatic algae |
Toxicity to microorganisms |
Target substance |
9005-65-6 |
RA CAS 9005-64-5 |
Data waiving |
RA CAS 1338-43-8 |
RA CAS 9005-64-5 |
RA CAS 9005-64-5 |
NOEC (14 d) ≥ 16.84 mg/L |
Source 1 |
9005-64-5 |
LL50 (96 h) > 100 mg/L |
-- |
-- |
NOELR (21 d): 10 mg/L |
ErL50 (72 h): 58.84 mg/L ErL10 (72 h): 19.05 mg/L |
NOEC (14 d) ≥ 100 mg/L |
Source 3 |
1338-43-8 |
-- |
-- |
LL50 (48 h) > 10000 mg/L
|
-- |
-- |
-- |
Source 2 |
9005-65-6 (Tween 80; (polysorbat 80 [sorbitan monooleate ethoxylated (20EO)]) |
-- |
-- |
-- |
-- |
No toxicity to algae was observed (No ECx value derived) |
-- |
In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across,Sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) (CAS 9005-65-6) is considered to be of low toxicity to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae and long-term results on toxicity to aquatic invertebrates. The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same results for sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated). The target as well as the source substances are characterised by the same alcohol component (sorbitan). Sorbitan is mono-esterified with fatty acids of a chain lengths of C12-C14 and C18 unsatd., respectively. This allows for closing data gaps with the selected source substances. No trend in toxicity was observed. There is no convincing evidence that any one of the source substances might lie out of the overall profile of the target substance. No structural alerts leading to aquatic toxicity were identified. A detailed justification for the analogue approach is provided in the technical dossier (see IUCLID Section 13).
Aquatic toxicity
Experimental studies for the target substance sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) (CAS 9005-65-6) are available investigating the toxicity to microorganisms. The endpoints short-term toxicity to fish, short-term toxicity to aquatic invertebrates, toxicity to algae as well as the long-term toxicity to aquatic invertebrates were covered by suitable read-across substances. The target substance is characterized by sorbitan mono-esterified with C18 unsatd. fatty acid (degree of ethoxylation: 3 and 5). The read-across substance sorbitan monolaurate, ethoxylated (CAS 9005-64-5) is specified as a monoester of sorbitan with C12 - C14 fatty acids (degree of ethoxylation: 1 - 6.5). Sorbitan oleate (CAS 1338-43-8) which was also used for read-across is characterized as a monoester of sorbitan with a C18 unsatd. fatty acid (degree of ethoxylation: 0).
The short-term toxicity to fish was investigated in one GLP-Guideline study according to OECD 203. A limit test with a nominal Water Accommodated Fraction (WAF) of 100 mg/L was tested. No mortality was recorded after 96 h resulting in a LL50 (96 h) of > 100 mg/L. The same result was obtained for the short-term toxicity to aquatic invertebrates which was tested according to “PARCOM (1991) Ring Test Protocol: Acute toxicity to marine copepod Acartia tonsa” (GLP) with the marine copepod Acartia tonsa. No mortality was recorded after 48 h resulting in a LL50 > 10000 mg/L.
Since sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated) (CAS 9005-65-6) is characterized by a low water solubility long-term testing with aquatic invertebrates was considered to be more meaningful compared to short-term testing. The available long-term study was conducted according to OECD 211 (GLP) with the water flea Daphnia magna (Schlechtriem, 2012). The test organism was exposed to nominal test concentrations up to 100 mg/L for 21 d (WAF). At 32 mg/L, a significant effect on reproduction was observed. Also the body length of parent animals was affected by the treatment at this concentration, and 60% parental mortality occurred. At 100 mg/L, 100% mortality of the parent animals was observed. Therefore, reproduction could not be evaluated for this concentration. The NOELR (21 d) for reproduction was thus determined to be 10 mg/L.
Toxicity testing with aquatic algae was conducted according to OECD 201 (GLP) with the freshwater algae Pseudokirchneriella subcapitata (Wenzel, 2012). The test organism was exposed to the test substance in a static system for 72 hours, at the nominal test concentrations of 1.0, 3.16, 10.0, 31.6 and 100 mg/L. The test solutions were prepared as water accommodated fractions (WAF). ErL50 (72 h) and ErL10 (72 h) values of 58.84 mg/L and 19.05 mg/L, respectively, were derived.
The degradation process in sewage treatment plants (STP) is not considered to be inhibited based on the result of a toxicity control with activated sludge microorganisms from a commercial STP according to ISO 14593:1999 (GLP). No inhibition of degradation was observed up to a limit concentration of 16.84 mg/L resulting in a NOEC (14 d) ≥ 16.84 mg/L.
In summary, based on experimental data from suitable read-across substances, the target substance is of low toxicity to aquatic organisms.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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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