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EC number: 905-964-4 | CAS number: -
Justification for grouping of substances and read-across
There are no data available on the acute toxicity of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".
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 human 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 and toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of skin sensitisation
"Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"
134.13 - 218.20 g/mol
RA: CAS 102-76-1
The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin".
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Since no studies are available investigating the sensitisation potential of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin", in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across from the structurally related
A study investigating the skin sensitisation properties of Triacetin (CAS 102-76-1) using the “drop-on-method” is available (Eastman, 1955). The skin of 5 guinea pigs was exposed to Triacetin. Phenylhydrazine was used as a positive control and skin scores were evaluated after 24 and 48 h. Triacetin was evaluated to be a non-sensitizer. Further guinea pig skin sensitisation studies with Triacetin (CAS 102-76-1) were reported as short abstracts from a secondary source (Fiume, 2003). Unichema Chemie B.V. (1994) evaluated the sensitisation potential of Triacetin in acetone, dioxane, and guinea pig fat (7:2:1) using guinea pigs. The animals were initially inducted three times over 5 days and challenged after 1, 2, or 3 weeks. A vehicle and positive control were included in the study. Triacetin was found to be not sensitising. Further summaries describe that Triacetin is not a sensitiser in guinea pigs as well (Unichema International 1996; Unichema Chemie B.V. 1994; Opdyke 1978).
In addition, human data from a clinical maximization test (occlusive human patch test) with undiluted Triacetin (CAS 102-76-1) in 33 human subjects is available (Epstein, 1976). Triacetin was applied under an occlusive patch to the volar aspect of the forearm for 48 h on 5 alternate days. Because a pre-test indicated that Triacetin was not an irritant, the test site was pre-treated for 24 h with 2% sodium lauryl sulfate (SLS) under an occlusive patch prior to application of the initial test patch. After a 10 to 14-day non- treatment period, challenge patches were applied to a previously unexposed site on the right side of the back. Prior to challenge, 2% SLS was applied for 30 min under an occlusive patch to the left side of the back. Additional SLS control patches and petrolatum patches were placed on the left and right sides, respectively, and used as controls. Undiluted Triacetin did not produce an irritant or sensitisation reaction in this study.
Conclusion for skin sensitisation
Several guinea pig studies did not show skin sensitising properties of the structurally related substance Triacetin (CAS 102-76-1). In addition, an occlusive human patch test with Triacetin (CAS 102-76-1) showed no sensitising potential. Thus, no skin sensitisation potential of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin" is identified.
Based on read-across from the source substance Triacetin following an analogue and weight of evidence approach, the available data on skin sensitising properties of "Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"
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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