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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Reference Type:
secondary source
Title:
Final report on the safety assessment of triacetin.
Author:
Fiume, M.Z.
Year:
2003
Bibliographic source:
Int J Toxicol. 2003;22 Suppl 2:1-10.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Clinical maximization test: A maximization test for undiluted Triacetin was performed using 33 subjects.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triacetin

Method

Type of population:
general
Ethical approval:
not specified
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: maximization test

ADMINISTRATION
- Type of application: occlusive
- Concentrations: undiluted

Triacetin was applied under an occlusive patch to the volar aspect of the forearm for 48 h on 5 alternate days. Because a pretest indicated the Triacetin was not an irritant, the test site was pretreated 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 nontreatment 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.

Results and discussion

Results of examinations:
Undiluted Triacetin did not produce an irritant or sensitization reaction.

Applicant's summary and conclusion

Conclusions:
Triacetin was not sensitising in human subjects under the given circumstances.