Calcium 4-[(4-chloro-3-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

Patch test was conducted for the given test chemical.

Author:

Guin JD

Year:

2003

Bibliographic source:

Contact Dermatitis

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch test was perfomed on humans to determine the sensitization potential of the test chemical.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

EC Number:

227-497-9

EC Name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Cas Number:

5858-81-1

Molecular formula:

C18H14N2O6S.2Na

IUPAC Name:

disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:

other: humans

Strain:

other: not applicable

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

other: epicutaneous

Vehicle:

water

Concentration / amount:

20%

Day(s)/duration:

7 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

other: epicutaneous

Vehicle:

water

Concentration / amount:

20%

Day(s)/duration:

7 days

Adequacy of challenge:

not specified

No. of animals per dose:

Total = 15 patients

Details on study design:

The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ?+. + and ++ categories.

Challenge controls:

no data available

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

168

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

15

Clinical observations:

None of the treated patients showed allergic contact dermatitis.

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table 1:  Patch test results

 

Concentration tested	No of patients tested	?+	+	++
20% aqueous	15	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.

Executive summary:

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. The dye was applied on15 patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.