Registration Dossier
Registration Dossier
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EC number: 305-632-3 | CAS number: 94891-32-4
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 safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON TEST CHEMICAL
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 007
- Bibliographic source:
- Scientific Committee on Consumer Safety (SCCS)-SCCP/1102/07
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Maximization test of chemical was conducted in female 15 Guinea pig to determine the degree of sensitization caused by the chemical.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 222-656-9
- EC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3567-66-6
- Molecular formula:
- C16H13N3O7S2.2Na
- IUPAC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Common Name: Acid Red 33
- Molecular formula: C16H13N3O7S2.2Na
- Molecular weight : 467.389 g/mol
- Smiles notation : [Na+].[Na+].Nc1cc(S(=O)(=O)[O])cc2cc(S(=O)(=O)[O-])c(N=Nc3ccccc3)c(O)c12
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- female
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1% CMC (carboxymethyl cellulose)
- Concentration / amount:
- intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC - Day(s)/duration:
- 18 hours
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% CMC (carboxymethyl cellulose)
- Concentration / amount:
- 25% dilution in 1% CMC
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 15 female (10 test and 5 control)
- Details on study design:
- Details on study design
RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:1
- Exposure period: No data available
Intradermal induction: 1 week
Epidermal induction:18 hr
- Test groups:10 Guinea pig
- Control group: 5Guinea pig
- Site:nuchal region
- Frequency of applications: 1
- Duration: No data available
- Concentrations:Intradermal induction: 5% dilution of test item in 1% CMC and in an
emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:No data
- Exposure period:No data
- Test groups: 10 Guinea pig
- Control group: 5Guinea pig
- Site: No data
- Concentrations:25% dilution in 1% CMC
-Evaluation (hr after challenge):24 and 48 hr - Challenge controls:
- The animals of the control group were epidermally induced with 1% CMC under occlusion.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non sensitizer in Control Group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- non sensitizer in Control Group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non sensitizer in Test Group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- non sensitizer in Test Group
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- no skin senitization was observed in treated animals.
Any other information on results incl. tables
Skin reactions after the challenge procedure:
|
After 24 hours |
After 48 hours |
||
|
Positive / total |
% positive |
Positive / total |
% positive |
Control Group |
|
|
|
|
test chemical 1% CMC (left flank) |
0 / 5 |
0 |
0 / 5 |
0 |
1% CMC only (right flank) |
0 / 5 |
0 |
0 / 5 |
0 |
Test Group |
|
|
|
|
test chemical , 25% in 1% CMC (left flank) |
0 / 10 |
0 |
0 / 10 |
0 |
1% CMC only (right flank) |
0 / 10 |
0 |
0 / 10 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The study concluded that the test substance D & C Red no. 33 (CAS no: 3567-66-6) was considered as non skin sensitizer.
- Executive summary:
The Maximization test of test chemical was conducted in female 15 (10 test and 5 control) Guinea pig to determine the degree of sensitization caused by the chemical. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction. The test areas are pretreated with 10 sodium-laureth-sulfates (SLS) 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. No known skin sensitization reactions were observed in treated as well as control group. Hence the test chemical was considered to be not sensitizing.
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