Registration Dossier
Registration Dossier
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EC number: 904-139-6 | CAS number: -
Skin sensitisation
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:
- 2 001
- 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:
- 2 011
- 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
- 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
Constituent 1
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.
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