Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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 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:
other: Patch test
Principles of method if other than guideline:
The sensitization potential of the test chemical was examined to determine the allergic contact dermatitis caused by the chemical via 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 :disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B
- Molecular formula :C18H14N2O6S.2Na
- Molecular weight:432.38 g/mole
- Substance type:Organic

In vivo test system

Test animals

Species:
other: humans
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
20%
Day(s)/duration:
7 days
Adequacy of challenge:
not specified
No. of animals per dose:
15 patients
Details on study design:
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 availble
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
168
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
None of the treated patients showed allergic contact dermatitis.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
None of the treated patients showed allergic contact dermatitis.

Any other information on results incl. tables

Table 1:  Patch test results

 

Chemical

No of patients tested

?+

+

++

D & C Red No. 6 (20% aq.)

15

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No patients showed any signs of sensitization. Thus the chemical can be considered as non sensitizer to human skin.
Executive summary:

Patch tests were performed on human volunteers to determine whether allergic contact dermatitis was caused by the test chemical. 20% dye in water was applied on the skin of 15 patients in Finn Chambers. The skin 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.

None of the treated patients showed any signs of allergic contact dermatitis. Hence, the test chemical can be considered as non sensitizer to human skin.