Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]

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 testing to FD&C and D&C dyes

Author:

Guin JD.

Year:

2003

Bibliographic source:

Contact Dermatitis 2003: 49: 217–218

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

The sensitization potential of D&C Red 28 was determined by performing patch test on humans.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

No data available

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid

EC Number:

242-355-6

EC Name:

3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid

Cas Number:

18472-87-2

Molecular formula:

C20H4Br4Cl4O5.2Na

IUPAC Name:

2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one

Test material form:

solid

Details on test material:

-Name of test material (as cited in study report): D&C Red 28 also known as Phloxine B
-Molecular formula: C20H4Br4Cl4O5.2Na
-Molecular weight : 829.6388g/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&C Red 28 also known as Phloxine B
-Molecular formula: C20H4Br4Cl4O5.2Na
-Molecular weight : 829.6388g/mol
-Substance type: Organic
-Physical state: Solid

In vivo test system

Test animals

Species:

human

Strain:

other: not applicable

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2% in petrolatum

Challenge

No.:

#1

Route:

other: no data

Vehicle:

petrolatum

Concentration / amount:

2% in petrolatum

No. of animals per dose:

9 patients

Details on study design:

OTHER: 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

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

2%

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

non sensitising

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: non sensitising.

Any other information on results incl. tables

Table 1:  Patch test results

 

Chemical	No of patients tested	?+	+	++
D&C Red 28 (1% in pet.)	9	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Conclusions:

The sensitization potential of D&C Red 28 (18472-87-20) was considered to be a non- sensitizing in humans

Executive summary:

The sensitization potential of D&C Red 28 was determined by performing patch tests on humans. 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 9 patients were tested with the dye.No reactions were reported by all the patients.Hence D&C Red 28 can be considered as a non- sensitizer in humans.