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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
human patch test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from review article

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final Report on the Safety Assessment of Acetyl Triethyl Citrate, Acetyl Tributyl Citrate, Acetyl Trihexyl Citrate, and Acetyl Trioctyl Citrate
Author:
Cosmetic Ingredient Review
Year:
2002
Bibliographic source:
International Journal of Toxicology, 21(Suppl. 2):1–17
Reference Type:
other: secondary citation
Title:
Repeated insult patch test on Citroflex 2 liquid, Citroflex A-2 liquid, and Citroflex A-4 liquid.
Author:
Hill Top Research, Inc.
Year:
1978
Bibliographic source:
Unpublished data submitted by CTFA, December 4, 1998. (3 pages.)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
ATEC was evaluated in 59 human subject panelists (males and females) in the repeated insult patch test of Draize. The test substance was found not to induce dermal irritation or contact sensitization. For this test, each of the 59 panelists received a test patch (20x20 cm) moistened with 0.4 mL of ATEC to the upper arms 3 times a week for 3 weeks. Patches were secured in place for 24 hours before removal. Duplicate challenges were made 2 weeks after the final serial applications, 1 set of patches to original sites and 1 set to adjacent sites. Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Existing study

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethyl O-acetylcitrate
EC Number:
201-066-5
EC Name:
Triethyl O-acetylcitrate
Cas Number:
77-89-4
Molecular formula:
C14H22O8
IUPAC Name:
triethyl 2-acetoxypropane-1,2,3-tricarboxylate

In vivo test system

Test animals

Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
59 human subject panelists (males and females)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications
Dose level:
0.4 mL
No. with + reactions:
0
Total no. in group:
59
Clinical observations:
no data
Remarks on result:
other: Reading other:
Remarks:
Patch sites were scored prior to patch applications and scored at 48 and 96 hours after applications. Dose level: 0.4 mL. No with. + reactions: 0.0. Total no. in groups: 59.0. Clinical observations: no data.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
ATEC is not considered to have a sensitising potential.
Executive summary:

ATEC was evaluated in 59 human subject panelists (males and females) in a repeated insult patch test of Draize. The test substance was found not to induce dermal irritation or contact sensitization.