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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary source.

Data source

Reference
Reference Type:
secondary source
Title:
Skin sensitization test
Author:
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP)
Year:
2004
Bibliographic source:
THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP); 2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The skin sensitization study of test substance was conducted on guinea pigs to determine its sensitization potential.
GLP compliance:
not specified
Type of study:
other: No data available.
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt
EC Number:
222-529-8
EC Name:
Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt
Cas Number:
3520-42-1
Molecular formula:
C27H30N2O7S2.Na
IUPAC Name:
sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate; 2-(3-diethylamino-6-diethylazaniumylidene-xanthen-9-yl)-5-sulfo-benzenesulfonate
Constituent 2
Reference substance name:
C.I. Acid Red 52
IUPAC Name:
C.I. Acid Red 52
Test material form:
solid
Details on test material:
- Name of test material: C.I. Acid Red 52- Molecular formula: C27H30N2O7S2.Na- Molecular weight: 580.6551 g/mol- Substance type: Organic- Physical state: SolidPurity: No data available- Impurities (identity and concentrations):No data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
Intradermal Induction:•Freund´s Complete Adjuvant (FCA) and physiological saline (1:1)•Acid Red 52 at 5% in 1 % CMC•5 % dilution of the Acid Red 52 in 1% CMC in a 1:1 mixture with FCA / physiological saline.Epidermal Induction:•50% in 1% CMC solution
Day(s)/duration:
Intradermal Induction: 7 days Epidermal Induction: 48 hour
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
10%
Day(s)/duration:
24 and 48 hour
Adequacy of challenge:
not specified
No. of animals per dose:
10 females: test group, 5 females :control group
Details on study design:
Details on study designRANGE FINDING TESTS:MAIN STUDYA.1. INDUCTION EXPOSURE: Intradermal Induction:- No. of exposures:1- Exposure period:7 days- Test groups:10 females- Control group:5 females- Site:- Frequency of applications:- Duration: 7 days- Concentrations: •Freund´s Complete Adjuvant (FCA) and physiological saline (1:1)•Acid Red 52 at 5% in 1 % CMC•5 % dilution of the Acid Red 52 in 1% CMC in a 1:1 mixture with FCA / physiological salineA.2. INDUCTION EXPOSURE: Epidermal Induction- No. of exposures:1- Exposure period:48 hours- Test groups: 10 females- Control group: 5 females- Site:- Frequency of applications:- Duration: 48 hours- Concentrations: 50% in 1% CMC solutionB. CHALLENGE EXPOSURE- No. of exposures:1- Day(s) of challenge: on day 22- Exposure period:24 hours- Test groups: 10 females- Control group: 5 females- Site: different part of the skin- Concentrations: 10% in 1% CMC solution- Evaluation (hr after challenge): at 24 and 48 hours removal of the dressings
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effect observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No effects were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
After challenge exposure, no skin reactions were observed. Hence, the test chemical was considered to be non sensitizing to the Himalayan spotted albino guinea pigs.
Executive summary:

The dermal sensitization potential of test chemical was assessed in guinea pigs. The study was performed as per OECD 406 Guidelines. 10 female were used for and 5 female Himalayan spotted guinea pigs were used in the test and control groups respectively.

In induction treatment, 10 females in test group, 5 females in control group were used. Animals were induced with intradermal induction of Freund´s Complete Adjuvant (FCA) and physiological saline (1:1), test item at 5% in 1 % CMC and 5 % dilution of the test item in 1% CMC in a 1:1 mixture with FCA / physiological saline on day 1. After 7 days, epidermal induction of sensitization (day 8) was conducted under occlusion with the test item at 50 % in 1 % CMC for 48 hours. The challenge was performed at day 22 by application of the test item at 10 % in 1 % CMC under occlusive patch for 24 h at a different part of the skin. Observations were made at 24 and 48 hours removal of the dressing.

 

After challenge exposure, no skin reactions were observed. Hence, sodium the test chemical was considered to be non-sensitizing to the Himalayan spotted albino guinea pigs.