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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:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

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 the test chemical 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
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

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
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:
1 % in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1 % in petrolatum
Adequacy of challenge:
not specified
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:
1st reading
Hours after challenge:
168
Group:
test group
No. with + reactions:
1
Total no. in group:
16
Clinical observations:
one positive reaction was observed of 16 patients tested
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Positive reaction was reported in 1 patient of the 16 tested. Hence, the test chemical can be considered as a non- sensitizer in humans
Executive summary:

The sensitization potential of the test chemical was determined by performing patch tests on humans. The dye was applied in Finn Chambers to the skin of 16 patients. The dermal reactions were 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.

Positive reaction was reported in 1 patient of the 16 tested. Hence, the test chemical can be considered as a non- sensitizer in humans.