Registration Dossier
Registration Dossier
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EC number: 214-686-6 | CAS number: 1185-57-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Final Report On the Safety Assessment of test chemcial.
- Author:
- Cosmetic Ingredient Review Expert Panel members
- Year:
- 2 012
- Bibliographic source:
- Cosmetic Ingredient Review,2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of the test chemical on 702 contact dermatitis patients.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- IUPAC Name:
- Citric acid
- Test material form:
- solid: crystalline
- Details on test material:
- Name of the test chemical: citric acid; 3-hydroxy-3-carboxy-1,5-pentanedioic acid
Molecular Formula:C6H8O7
Molecular Weight: 192.122 g/mol
InChI: 1S/C6H8O7/c7-3(8)1-6(13,5(11)12)2-4(9)10/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
Substance Type: Organic
Physical State: Solid
Purity:60%
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 702 contact dermatitis patients were used
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hrs
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 702 contact dermatitis patients
- Details on study design:
- No data available
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 708
- Clinical observations:
- No skin allergic reactions were observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No positive skin sensitization reactions were observed. Hence, the test chemical was considered to be not sensitizing to human skin.
- Executive summary:
Human maximization test was performed to evaluate the dermal sensitization potential of the test chemical on 702 contact dermatitis patients. The test material was introducted to the subjects by finn chambers applied on the back using Scanpor tape for 48 h.
No positive skin sensitization reactions were observed. Hence, the test chemical was considered to be not sensitizing to human skin.
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