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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
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
Justification for type of information:
Data is from Cosmetic Ingredient Review.

Data source

Reference
Reference Type:
publication
Title:
Determination of skin sensitization of Citric acid.
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2012
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 access skin sensitization by Human Repeat Insult Patch Test (HRIPT).
GLP compliance:
not specified
Type of study:
not specified

Test material

Constituent 1
Chemical structure
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; 3-hydroxy-3-carboxy-1,5-pentanedioic acid
Test material form:
solid: crystalline
Details on test material:
Name of the test chemical: citric acid; 3-hydroxy-3-carboxy-1,5-pentanedioic acidMolecular Formula:C6H8O7Molecular Weight: 192.122 g/molInChI: 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: OrganicPhysical State: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Citric acid- Molecular formula : C6H8O7- Molecular weight : 192.122 g/mol- Substance type: Organic- Physical state: solid

In vivo test system

Test animals

Species:
other: Human
Strain:
other: not applicable
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
other: Cuticle cream
Concentration / amount:
4%
Day(s)/duration:
21 days
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, occlusive
Concentration / amount:
4%
No. of animals per dose:
56 humans
Details on study design:
MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 3- Exposure period: 3 weeks - Test groups: 56 patient- Frequency of applications: 3x/wk - Duration: 3 weeks- Concentrations: 4%B. CHALLENGE EXPOSURE- Exposure period: challenge patch wasapplied after 2 wks
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
56
Clinical observations:
No sensitization
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: non-sensitizing
Conclusions:
The citric acid (77-92-9) was considered to be non-toxic to human patient and based on that can be considered to be non-sensitizer.
Executive summary:

Skin sensitization test was performed in 56 patients by applying 4% in a cuticle cream by HRIPT methods. Semi occlusive patches were applied 3x/wk for 3 wks in induction exposure and continue after 2 week in challenge exposure.After the experiment, no reaction was obtain hence, the citric acid was considered to non-toxic to human patient and based on that can be considered to be non-sensitizer.