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Toxicological information

Sensitisation data (human)

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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:
1998
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:
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
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

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.