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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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

Referenceopen allclose all

Reference Type:
secondary source
Title:
Science Assessment of ATBC and TEC
Author:
Boyle K
Year:
2004
Bibliographic source:
Memorandum from Kathryn Boyle, Inerts team to Dan Rosenblatt, Chief, Minor Use, Inerts and Emergency Response Branch.
Report Date:
2004
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

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Testing predates current accepted testing philosophies.

Test material

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

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Concentration / amount:
Induction: 2.5% in 0.01% Dobs/saline.
Induction-dermal: (occlusive patch application) with 100%.
Challenge (covered patch application) with 50% in absolute ethanol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
Induction: 2.5% in 0.01% Dobs/saline.
Induction-dermal: (occlusive patch application) with 100%.
Challenge (covered patch application) with 50% in absolute ethanol
No. of animals per dose:
9 (one dose group)
Details on study design:
Nine guinea pigs according to the Magnusson-Kligman guinea pig maximization test method. Sensitization was induced by intradermal injections of both test substance and Freunds Adjuvant and the induction process supplemented seven days later by the test substance applied to the shoulder injection sites under occlusion. The animals were challenged by occluded patch 14 days later.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
single dose
No. with + reactions:
9
Total no. in group:
9
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: single dose. No with. + reactions: 9.0. Total no. in groups: 9.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Triethyl citrate is a strong dermal sensitiser in guinea pigs, under the conditions of the Magnusson Kligman Maximization Test.