3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peerreviewed 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 mentioned below

Principles of method if other than guideline:

The sensitization potential of D&C yellow 8 was determined by performing patch test on humans.

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 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

EC Number:

208-253-0

EC Name:

Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

Cas Number:

518-47-8

Molecular formula:

C20H12O5.2Na

IUPAC Name:

disodium 3-oxo-3H-spiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate

Test material form:

solid

Details on test material:

Name of test material (as cited in study report): D&C yellow 8
Molecular formula : C20H10O5.2Na
Molecular weight : 376.274 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&C yellow 8
Molecular formula (if other than submission substance): C20H10O5.2Na
Molecular weight (if other than submission substance): 376.274g/moi
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:

other: Finn Chambers

Vehicle:

other: Petrolatum

Concentration / amount:

8.1 %

Day(s)/duration:

2-3 days

Challenge

Route:

other: Finn Chambers

Vehicle:

petrolatum

Concentration / amount:

8.1%

Day(s)/duration:

4-7 days

No. of animals per dose:

16 patients

Details on study design:

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.

Challenge controls:

No data available

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

other: Non-sensitiser

Hours after challenge:

168

Group:

test chemical

Dose level:

8.1%

No. with + reactions:

1

Total no. in group:

16

Clinical observations:

not sensitising

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

 Patch test results

 

Chemical	No of patients tested	?+	+	++
D&C yellow 8 (1% in pet.)	16	0	0	1

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans.16 patients were tested with the dye. Only 1 positive reactions was reported by a patient.D&C yellow 8 can be considered as a non- sensitizer in humans

Executive summary:

The sensitization potential of D&C yellow 8 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 16 patients were tested with the dye.Only 1 positive reactions was reported by a patient.

 D&C yellow 8 can be considered as a non- sensitizer in humans.Therefore D&C yellow 8 can be considered as a non- sensitizer in humans.