Registration Dossier
Registration Dossier
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EC number: 947-402-0 | 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:
- 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:
- 2 004
- 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
- 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
- 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
Constituent 1
Constituent 2
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.
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