Registration Dossier

Administrative data

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.

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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
no data

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.