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Toxicological information

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:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin sensitization study of disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate was performed by Maximization test in guinea pig.
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): Acid red 33
-IUPAC name: disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- 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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm: GOHI
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Concentration / amount:
intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline

Challenge: 25% dilution in 1% CMC
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Concentration / amount:
Epidermal induction: 25% dilution in 1% CMC
Day(s)/duration:
48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: 1% CMC and in an emulsion of FCA/physiological saline
Concentration / amount:
Challenge: 25% dilution in 1% CMC
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
Total:15 female
Test group:10
control group:5
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
- Frequency of applications: On day 1 and 8
- Duration: 1 week
- Concentrations:for the intradermal induction: 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline.
For epidermal induction :25% in 1% CMC

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24hr
- Test groups: 10
- Control group: 5
- Site: nuchal region
- Concentrations: 25% in 1% CMC
- Evaluation (hr after challenge): 24 and 48 hr

OTHER : The pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item during epidermal induction. 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.
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:
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 group
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 group
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

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

 

 

 

 

D&C Red 33, 25% in 1% CMC (left flank)

0 / 5

0

0 / 5

0

1% CMC only (right flank)

0 / 5

0

0 / 5

0

Test Group

 

 

 

 

D&C Red 33, 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:
No skin sensitization reaction was observed. Hence, disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate(3567 -66 -6) was considered to be not skin sensitizing in guinea pig.
Executive summary:

A maximisation test of Acid red 33 (3567 -66 -6) was performed in 15 (10 test and 5 control) female guinea pigs. The intradermal induction of sensitisation 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 sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulfate (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 skin sensitization reaction was observed. Hence, disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate(3567 -66 -6) was considered to be not skin sensitizing in guinea pig.