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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Epidemiological data

Currently viewing:

Administrative data

Endpoint:
epidemiological data
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated as reliable by authoritative bodies, including the 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:
epidemiological data
Type of information:
other: secondary source
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Evaluated as reliable by authoritative bodies, including the JECFA, EFSA, CSTEE, U.S. Environmental Protection Agency, Cosmetic Ingredient Review Panel, etc.
Study type:
other: volunteer panel
Endpoint addressed:
skin irritation / corrosion
Qualifier:
no guideline available
Principles of method if other than guideline:
Human patch testing of volunteers, maximization protocol
GLP compliance:
not specified
Type of population:
general
Ethical approval:
not specified
Details on study design:
Twenty-two volunteers were treated with 20% triethyl citrate in petrolatum in a maximization protocol. The test involved an induction phase of 5 consecutive 48-hr covered patch tests, sometimes separated by 24-hr periods of treatment with a mild irritant, followed 10-14 days later by a final 48-hr closed patch test with the same concentration.
Exposure assessment:
measured
Results:
No dermal irritation observed.
Conclusions:
Triethyl citrate (20% in petrolatum) was not irritating in repeated closed patch testing. The substance is non-irritating in humans.

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

Study type:
other: volunteer panel
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human patch testing of volunteers, maximization protocol
GLP compliance:
not specified

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:
not specified
Details on study design:
Twenty-two volunteers were treated with 20% triethyl citrate in petrolatum in a maximization protocol. The test involved an induction phase of 5 consecutive 48-hr covered patch tests, sometimes separated by 24-hr periods of treatment with a mild irritant, followed 10-14 days later by a final 48-hr closed patch test with the same concentration.
Exposure assessment:
measured

Results and discussion

Results:
No dermal irritation observed.

Applicant's summary and conclusion

Conclusions:
Triethyl citrate (20% in petrolatum) was not irritating in repeated closed patch testing. The substance is non-irritating in humans and the target substance is expected to show the same response.