Triacetin

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

Test material information

Constituent 1

Reference substance name:

Triacetin

EC Number:

203-051-9

EC Name:

Triacetin

Cas Number:

102-76-1

Molecular formula:

C9H14O6

IUPAC Name:

1,3-bis(acetyloxy)propan-2-yl acetate

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.