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Toxicological information

Skin sensitisation

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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.