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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Notice of filing of a pesticide petition to establish a tolerance for a certain pesticide chemical in or on food
Author:
Anon.
Year:
2001
Bibliographic source:
US Federal Register Vol. 66, No. 4, pages 1129-1135
Reference Type:
review article or handbook
Title:
Citric acid and its inorganic salts and alkyl and glycol esters as used in cosmetics - draft safety assessment
Author:
Anon.
Year:
2011
Bibliographic source:
Cosmetic ingredient review

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study undertaken in 1976, before the introduction of the LLNA method.

Test material

Constituent 1
Chemical structure
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 2-hydroxypropane-1,2,3-tricarboxylate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: saline
Concentration / amount:
2.5%
Adequacy of induction:
not specified
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
48 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10 test, 4 control
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - 1 x intradermal, 1 x epicutaneous
- Exposure period: Intradermal injection on Day 0, 48 hour epicutaneous exposure on Day 7
- Test groups: 10 animals
- Control group: 4 animals
- Site: Shoulder region

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours
- Site: Flank
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
not specified
No. with + reactions:
9
Total no. in group:
9
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
not specified
No. with + reactions:
9
Total no. in group:
9
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
not specified
No. with + reactions:
0
Total no. in group:
4
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
not specified
No. with + reactions:
0
Total no. in group:
4
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Executive summary:

A Magnusson and Kligman guinea pig maximisation test indicates triethyl citrate to be a skin sensitiser.