Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is 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 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

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EC 905-964-4

CAS 102-76-1

Chemical name

"Reaction mixture of glycerol-1,3-di(acetate), glycerol acetate and triacetin"

Triacetin

Molecular weight

134.13 - 218.20 g/mol

218.20 g/mol

Skin sensitisation

RA: CAS 102-76-1

Not sensitising

 

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

analogue substance Triacetin (CAS 102-76-1) was conducted.

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.


Migrated from Short description of key information:
Skin sensitisation: not sensitising (drop-on method)

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

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"

do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.