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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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:

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.