Registration Dossier
Registration Dossier
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EC number: 943-149-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
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 target and the source substance 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 Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids.
The target substance is a UVCB substance specified by the reaction product of mainly C16 and C18 linear fatty acids with sucrose, glycerol and propane-1,2-diol.. The source substance Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids (List No. 938-754-6) is an UVCB substance resulting by the reaction of a fatty acid mixture with glycerol and sucrose. A detailed read-across justification is provided in the technical dossier (see IUCLID Section 13).
All available experimental studies on the target and the source substance were 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.Short-term toxicity to fish
In a 96-h acute toxicity study according to OECD TG 203, Leuciscus idus were exposed to Sucroglyceride C16-18 at nominal concentrations of 0 (control) 2000, 3000 and 4000 mg/L under static conditions. The test substance was directly transferred into the dilution water. No analyticyl control was performed. The 96 -h LC50is 3100 mg/l (arithmetical determination), 96 -h LC0is 2000 mg/L, the 96 -h LC100is 4000 mg/L.
Short-term toxicity to daphnia
The toxicity of the read across substance Sucroglyceride C12-18, C18unsatd. was investigated in a study conducted according to OECD Guideline 202 I (Daphnia sp. Acute Immobilisation Test), adopted April 4, 1984. In this test Daphnia magna were exposed to a nominal test substance concentrations of 10; 18; 32; 58; 100; 180 mg/L over a period of 48 h under static conditions. No analytical controls were performed.
The concentration with no effect (NOEC) based on immobilization was determined to be 18 mg/L after 48 h of exposure.The 48 h-EC50 was 28.5 mg/L (C.I. 26.4 to 30.8 mg/L).
Toxicity to algae
In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata, strain NIVA CHL 1 were exposed to the read across substance Sucroglyceride C12-18, C18unsatd. at nominal concentrations of 0 (control), 1.0, 3.2, 10, 32 and 100 mg/L under static conditions in accordance with the OECD guideline 201.
The EC50 for growth rate reduction (ErC50: 0-72 h) was 16 mg/L with a 95% confidence interval ranging from 11 to 24 mg/L.
The EC50 for yield inhibition (EyC50: 0-72 h) was 6.0 mg/L with a 95% confidence interval ranging from 2.6 to 13 mg/L.
The NOEC for growth rate reduction and yield inhibition was 3.2 and 1.0 mg/L, respectively.
Toxicity to microorganisms
In a 30 minutes toxicity study conducted according to DIN 38412 part 27 (Bacteria Respiration test), the cultures of Pseudomonas putida were exposed to Sucroglyceride C16-18 at nominal concentration of 8 and 10 g/Lunder static conditions. No analytical control was performed.
No inhibition of the bacterial respiration with the tested concentration was observed.
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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