Registration Dossier
Registration Dossier
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EC number: 201-070-7 | CAS number: 77-93-0
Epidemiological data
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:
- 2 012
- 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 substance name:
- Triethyl citrate
- EC Number:
- 201-070-7
- EC Name:
- Triethyl citrate
- Cas Number:
- 77-93-0
- Molecular formula:
- C12H20O7
- IUPAC Name:
- triethyl citrate
- Test material form:
- liquid: viscous
- Details on test material:
- no data
Constituent 1
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.
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