Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication meeting basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1963

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Clinical case report on a 29 years old patient with allergic contact eczema due to triacetin.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age: 29
- Other: The woman was occupationally exposed to triacetin during work in the production of filter cigarettes. In her anamnese it was noted that she previously had suffered from eczema on both hands during her previous work (tailoring of linen and silk blouses).
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional, occupational
Exposure assessment:
not specified

Results and discussion

Clinical signs:
20 other test persons with anamnesis of skin eczema were tested with different concentrations of triacetin and other cigarette filter material. None of the tested persons showed skin reactions on triacetin. Further analyses with the 29 years old woman showed that her allergic reaction was due to the acetic acid ester part of triacetin.

Any other information on results incl. tables

In an epicutan test performed with different concentrations of triacetin none of 20 subjects with anamnesis of skin eczema showed skin reactions. Only the woman, who had suffered from skin eczema on both hands also before occupational exposure to triacetin showed positive allergic reactions on triacetin.

The sensitisation potential of triacetin must be considered very low, as many smokers are in contact with triacetin during cigarette smoke, as triacetin is used as a stabilizer during cigarette filter production.

Applicant's summary and conclusion

Conclusions:
The sensitising potential of triacetin in humans was considered as negligible.