Registration Dossier
Registration Dossier
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EC number: 203-051-9 | CAS number: 102-76-1
Sensitisation data (human)
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:
- 1 976
- Reference Type:
- secondary source
- Title:
- Final report on the safety assessment of triacetin.
- Author:
- Fiume, M.Z.
- Year:
- 2 003
- 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 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
- Details on test material:
- - Name of test material (as cited in study report): Triacetin
Constituent 1
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.
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