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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 from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
WHO Food Additives Series 15
Author:
WHO Food Additives Series 15
Year:
1981
Bibliographic source:
WHO Food Additives Series 15, 1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Human maximization test
Principles of method if other than guideline:
Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical
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: particulate/powder
Details on test material:
-IUPAC name :Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
-Common name-1-(2-methoxy-5-methyl-4-sulfophenyl-1-azo)-6 sulfo-2-hydroxynapthalene, disodium salt ( ALLURA RED AC)
-Molecular formula:C18H16N2O8S2.2Na
-Molecular weight:496.4266 g/mol
- Substance type: Organic
- Physical state: solid
-InChI:1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
Smiles:c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Aqueous solution
Concentration / amount:
No data available
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: aqueous solution
Concentration / amount:
24 hours
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
200 subjects
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period:24 hours
- Test groups: 200 subjects
- Control group: no data
- Site: volvar forearms
- Frequency of applications:
- Duration: 10 alternate days
- Concentrations: no data

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days
- Exposure period: 24 hours
- Test groups: 200 subjects
- Control group:
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): after 24 hours
Challenge controls:
Not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
No data available
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
None of the subjects showed any signs of contact sensitization.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

 Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
Executive summary:

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours.

The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.

Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.