Isooctadecanoic acid, monoester with glycerol

Endpoint summary

Additional information

Data investigating the aquatic toxicity of Glycerol monoisostearate (CAS 66085-00-5) are not available.
In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted to fulfil the standard information requirements. 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). According to Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be considered to be similar if their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Data on the aquatic toxicity of the target substance and the source substances are displayed in the table below.

 

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
66085-00-5	RA CAS 67701-33-1	Waiving	RA CAS 97358-80-0 RA: CAS 91052-28-7	Waiving/RA 91052-28-7	RA CAS 122-32-7 RA CAS 91052-28-7	RA from CAS 122-32-7
122-32-7	WoE: Experimental result: LC50(48 h) >1000 mg/L + RA: CAS 91052-28-7	Waiving based on CSA	RA: CAS 91052-28-7	RA: CAS 91052-28-7	Experimental result: IC50 (72 h) >5 mg/L	Experimental result: NOEC(18 h) ≥0.8 mg/L
67701-33-1	Experimental result: LC50(96 h) >10000 mg/L	Waiving based on CSA	RA: CAS 91052-28-7	RA: CAS 91052-28-7	RA: CAS 91052-28-7	RA: CAS 122-32-7
97358-80-0	RA: CAS 8001-78-3	Waiving based on CSA	Experimental result: EL50 (48 h) >100 mg/L	RA: CAS 91052-28-7	RA: CAS 91052-28-7	RA: CAS 122-32-7
91052-28-7	WoE: Experimental result: LC50(48 h) >10000 mg/L + RA: CAS 122-32-7	Waiving based on CSA	Experimental result: EL50 (48 h) >100 mg/L	Experimental result: NOELR(21d) >10 mg/L	Experimental result: ErL50 (72 h) >320 mg/L NOELR (72 h) = 32 mg/L	RA: CAS 122-32-7
91744-28-4	RA: CAS 91052-49-2	Waiving	RA: CAS 91052-49-2	Expert statement	RA: CAS 91052-49-2	Experimental result: NOEC ≥ 41.1 mg/L (toxicity control biodegradation test)

 

The target and the source substances are esters of a tri-functional alcohol (glycerol) with one or more carboxylic (fatty) acid(s) chain(s). The alcohol moiety (glycerol) is common to all analogue substances. The fatty acid moiety comprises carbon chain lengths from C12-C18 (even-numbered) and includes mainly linear saturated alkyl chains, but also unsaturated and branched chains bound to the alcohol, resulting in mono-, di-, and tri-esters. The target substance and the source substances are characterised by a low water solubility, low vapour pressure and high log Koc. Thus, the substances are expected to have a similar environmental fate and ecotoxicity profile.
The available short-term and long-term studies indicate that the source substances are not acutely or chronically toxic to aquatic organisms up to the limit of water solubility of the source substances.

The acute toxicity tests on fish conducted with 1,2,3-propanetriyl trioleate (CAS 122-32-7), Glycerides, C14-18 mono- and di- (CAS 67701-33-1) and Glycerides,C14-18 and C16-18 unsatd, mono-, di- and tri- (CAS 91052-28-7) determined no toxicity of these substances up to the limit of their water solubility (LC50 values > 10000 mg/L). The available short-term toxicity test on aquatic invertebrates conducted with Glycerides,C14-18 and C16-18 unsatd, mono-, di- and tri- (CAS 91052-28-7) and isooctadecanoic acid, mono- and diesters with glycerol (CAS 97358-80-0) reported no immobilization up to the limit of water solubility or the highest attainable concentration in test solution (EL50 values > 100 mg/L). Studies on the toxicity to algae are available, for 1,2,3-propanetriyl trioleate (CAS 122-32-7) and C14-18 and C16-18 unsatd., mono-, di- and tri- (CAS 91052-28-7). The study on 1,2,3-propanetriyl trioleate (CAS 122-32-7) reported no toxicity up to the limit of water solubility (IC50(72 h) > 5 mg/L). The study conducted with CAS 91052-28-7, resulted in effects at concentrations above 32 mg/L, leading to an ErL50 > 320 mg/L and a NOEC of 32 mg/L, both well above the water solubility of the substance (WS < 0.05 mg/L). The stock solutions were reported to be clear and colourless but once again, due to the fact that the effects are observed above the water solubility value for this substance, physical effects cannot be excluded.

On study investigating the long-term toxicity of C14-18 and C16-18 unsatd., mono-, di- and tri- (CAS 91052-28-7) to Daphnia magna is available. No effects on reproduction or survival were determined and thus a NOELR (21d) >10 mg/L was reported.

The available studies on toxicity to aquatic microorganisms conducted with the source substance 1,2,3-propanetriyl trioleate (CAS 122-32-7) determined no detrimental effects.

Based on the result from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Glycerol monoisostearate (CAS 66085-00-5) is not acutely or chronically toxic to freshwater organisms up to the limit of the water solubility (WS < 0.05 mg/L).