Triacetin

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation - Animal data:

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 sulphate (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.

Skin sensitisation - Human data:

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 sulphate (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.

In another sensitisation study, 20 human subjects were exposed to a 50% Triacetin dilution using a Duhring-chamber test (Unichema, 1994). Triacetin was applied as a 50% dilution for 24 h. No evidence for a sensitising potential of the test substance was reported.

Only one clinical case report was available on the sensitisation potential of Triacetin (Unna and Schulz, 1963). A 29 years old patient suffered from allergic contact eczema due to occupational exposure to triacetin during work in the production of filter cigarettes. However, in the anamneses it was noted that the patient had already suffered from eczema on both hands during her previous work (tailoring of linen and silk blouses). Subsequently, 20 other test persons with anamnesis of skin eczema were tested with different concentrations of the substance and other cigarette filter material. None of the tested persons showed skin reactions after exposure to the substance.

Triacetin (glycerol triacetate) is allowed as a plasticizer in cigarette filters in most parts of the world. Furthermore, the substance is in many cosmetic formulations, like eyeliner or makeup bases and foods as flavouring agents or adjuvants. However, no human epidemiological data are available which would indicate a sensitising potential of the substance.

Migrated from Short description of key information:
Based on a weight of evidence approach of all available human and animal data, the substance was considered to be not sensitising.

Justification for selection of skin sensitisation endpoint:
Hazard assessment is based on the weight of evidence from all available studies.

Respiratory sensitisation

Endpoint conclusion

Additional information:

Migrated from Short description of key information:
No data available.

Justification for classification or non-classification

The available data on skin sensitising potential of the substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.