3-amino-5-hydroxynaphthalene-2,7-disulphonic acid

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 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

Test material information

Constituent 1

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)

Results

Results 1

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

Results 2

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.