Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

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
Constituent 2
Reference substance name:
Fluorescein sodium
IUPAC Name:
Fluorescein sodium
Test material form:
other: Solid
Details on test material:
Name of test material (as cited in study report): D&C yellow 8
Molecular formula (if other than submission substance): C20-H10-O5.2Na
Molecular weight (if other than submission substance): 376.274
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Petrolatum
Concentration / amount:
1 % in petrolatum
Challenge
Concentration / amount:
1 % in petrolatum
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.
The reactions of the patients were graded as
?+. + and ++ categories.
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
No. with + reactions:
1
Total no. in group:
16
Clinical observations:
not sensitising
Remarks on result:
other: Reading: other: Non-sensitiser. No with. + reactions: 1.0. Total no. in groups: 16.0. Clinical observations: not sensitising.

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:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.