Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature. Original report not available.

Data source

Referenceopen allclose all

Reference Type:
publication
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.
Reference Type:
other: letter
Title:
Letter dated September 13 from Dr. Anstadt, Eastman Kodak Co., to D. R. Mathieu, Flavor and Extract Manufacturer’s Association, regarding information on the toxicity of Triacetin.
Author:
Anstadt, G.W.
Year:
1976
Bibliographic source:
Data submitted by FDA in response to an FOI request.
Reference Type:
other: summary information
Title:
Summary information on Triacetin. Unpublished data received from CTFA. 32 pages.
Author:
Unichema Chemie B.V.
Year:
1994
Bibliographic source:
Available for review. Director, Cosmetic Ingredient Review, 1101 17th Street, N.W., Suite 310, Washington, DC 20036, USA.
Reference Type:
other company data
Title:
Unnamed
Year:
1996

Materials and methods

Principles of method if other than guideline:
Different methods were used to test the skin sensitization potential in guinea pigs.
GLP compliance:
no
Type of study:
other: drop-on method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): triacetin
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: not specified
Sex:
not specified

Results and discussion

Any other information on results incl. tables

Several animal studies and studies in human subjects were summarised.

The available informations were jugded to be sufficient to classify glycerol triacetate as not skin sensitising.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment