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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 from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Opinion of the Scientific Committee on Consumer Products on Acid Red 33 (C22)
Author:
European Commission
Year:
2007
Bibliographic source:
Opinion of the Scientific Committee on Consumer Products on Acid Red 33 (C22), 2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of D and C red 33 by Guinea pig maximization test was performed on guinea pig
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No data available

Test material

Constituent 1
Chemical structure
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-(phenyldiazenyl)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Molecular formula : C16H13N3O7S2.2Na
- Molecular weight : 467.3889 g/mol
- Substance type: Organic
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report):D and C Red 33
- Molecular formula : C16H13N3O7S2.2Na
- Molecular weight : 467.3889 g/mol
- Substance type: Organic
- Physical state: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: SPF
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: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
25% dilution in 1% CMC
No. of animals per dose:
Total:15
Test group:10
Control group:5
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period:18hr
- Test groups:10
- Control group:5
- Site: nuchal region of left flank
- Frequency of applications: one week after intradermal induction
- Duration:18hr
- 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 available
- Exposure period: No data available
- Test groups:10
- Control group:5
- Site: nuchal region of left flank
- Concentrations: 25% dilution in 1% CMC
- Evaluation (hr after challenge):24 and 48hr

OTHER: pre-treatment of the test areas with 10%sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item before epidermal induction
Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% dilution in 1% CMC
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Skin sensitization not observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% dilution in 1% CMC
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Skin sensitization not observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
Skin sensitization study of D and C red 33 (3567-66-6) by Guinea pig maximization test was performed on guinea pig was considered to be not skin sensitizing.
Executive summary:

In Guinea pig maximization test of D and C red 33 (3567-66-6) was performed in 15 female SPF guinea pig(10 test group and 5 in control group) also 2-mercaptobenzothiazole used as positive control. In induction phase, intradermal induction given as5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline to nuchal region of left flank, then after one week epidermal induction of 25% dilution in 1% CMC given in same region for 18hr, before that pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item given. 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. In challenge phase, test material 25% dilution in 1% CMC was applied epidermally on left flank and evaluated after 24hr and 48hr.No indication of skin sensitization was noted. Hence it is considered that D and C red 33 (3567-66-6) was not skin sensitizing in guinea pig by Guinea pig maximization test.