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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 safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON TEST CHEMICAL
Author:
Scientific Committee on Consumer Safety
Year:
2007
Bibliographic source:
Scientific Committee on Consumer Safety (SCCS)-SCCP/1102/07

Materials and methods

Test guideline
Qualifier:
according to
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
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

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 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

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.