Registration Dossier
Registration Dossier
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EC number: 201-070-7 | CAS number: 77-93-0
Sensitisation data (human)
Administrative data
- 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.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Toxicology Profile Triethyl Citrate
- Author:
- BIBRA
- Year:
- 1 998
- Bibliographic source:
- BIBRA Toxicology Advice and Consulting, Citylink Centre, Railway approach, Wallington, Surrey, SM6 0DZ, UK.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Kligman and Epstein, 1975
- Principles of method if other than guideline:
- Human patch testing, with and without irritant
- GLP compliance:
- no
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
- Details on test material:
- No data
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 22 volunteer
- Route of administration:
- dermal
- 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.
Results and discussion
- Results of examinations:
- No sensitisation occurred in 22 volunteers.
Applicant's summary and conclusion
- Conclusions:
- Triethyl citrate (20% in petrolatum) was not sensitising in a maximization protocol of repeated closed patch testing, with challenge 10-14 days later also with a closed patch. The substance is non-sensitising in humans.
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