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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated as reliable by several authoritative bodies, such as JECFA, EFSA, CSTEE, U.S. Environmental Protection Agency, Cosmetic Ingredient Review Panel, etc.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
sensitisation data (humans)
Type of information:
other: secondary source
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated as reliable by several authoritative bodies, such as JECFA, EFSA, CSTEE, U.S. Environmental Protection Agency, Cosmetic Ingredient Review Panel, etc.
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
no guideline available
Principles of method if other than guideline:
Human patch testing standard methods
GLP compliance:
no
Type of population:
general
Ethical approval:
other: assume that approval has been obtained
Subjects:
45 volunteers, 10 males, 35 females
Route of administration:
dermal
Details on study design:
41 volunteers were treated with 33.3 % triethyl citrate in petrolatum, 0.4 ml applied to a Webril patch affixed to an elastic bandage. It was applied 9 times for 24 hours each. Challenge patches were applied to the test site and an untested site.
Results of examinations:
No sensitisation occurred in 45 volunteers.
Conclusions:
Triethyl citrate (33.33% in petrolatum) was not sensitising or irritating in a HRIPT test in 45 human volunteers.

Data source

Reference
Reference Type:
secondary source
Title:
On the safety assessment of citric acid, inorganic citrate salts and alkyl citrate esters as used in cometics
Author:
Expert Panel, Cosmetic Ingredient Review
Year:
2012
Bibliographic source:
Cosmetic Ingredient Review, 1101 17th St. NW., Suite 412, Washington, DC 20036-4702
Report date:
2012

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human patch testing standard methods
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Trihexyl O-acetylcitrate
Cas Number:
24817-92-3
Molecular formula:
C26 H46 O8
IUPAC Name:
Trihexyl O-acetylcitrate
Test material form:
liquid

Method

Type of population:
general
Ethical approval:
other: assume that approval has been obtained
Subjects:
45 volunteers, 10 males, 35 females
Route of administration:
dermal
Details on study design:
41 volunteers were treated with 33.3 % triethyl citrate in petrolatum, 0.4 ml applied to a Webril patch affixed to an elastic bandage. It was applied 9 times for 24 hours each. Challenge patches were applied to the test site and an untested site.

Results and discussion

Results of examinations:
No sensitisation occurred in 45 volunteers.

Applicant's summary and conclusion

Conclusions:
Triethyl citrate (33.33% in petrolatum) was not sensitising or irritating in a HRIPT test in 45 human volunteers. The target substance, ATHC, is expected to show the same response.