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EC number: 203-051-9
CAS number: 102-76-1
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:
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
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.
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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