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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:
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

Constituent 1
Chemical structure
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.