Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
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 rerviewed journal and authoritative database

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
WHO Food Additives
Author:
Joint FAO/WHO Expert Committee on Food Additives
Year:
1980
Bibliographic source:
Joint FAO/WHO Expert Committee on Food Additives, 2004
Reference Type:
other: Authoritative data base
Title:
HSDB (Hazardous Substances Data Bank)
Author:
U.S National Library of Medicine
Year:
2011
Bibliographic source:
HSDB (Hazardous Substances Data Bank), U.S National Library of Medicine ; 2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin sensitization potential of the test chemical on 200 human subjects
GLP compliance:
not specified
Type of study:
other: Draize-Shelanski repeated insult 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:
- Name of test material (as cited in study report): disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
(ALLURA RED AC)
- 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:
water
Concentration / amount:
Not specified
Day(s)/duration:
10 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Not specified
Day(s)/duration:
24 hrs
Adequacy of challenge:
not specified
No. of animals per dose:
200 human subjects
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Exposure period: 24 hrs
- Test groups: 200 human subject
- Control group: no data
- Site: volvar forearms
- Duration: 10 days
- Concentrations: no data

B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Day(s) of challenge: 24 hrs
- Exposure period: 24 hrs
- Test groups: 200 human subjects
- Control group: no data
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): 24 hrs

OTHER: challenge treatment was given 14 days after induction
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
No positive skin allergic skings were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.
Hence, the test chemical was considered to be not sensitizing to skin .
Executive summary:

Draize- Shelanski Repeat Insult Patch Test was performed on 200 human subjects to determine the degree of dermal sensitization caused by the test chemical.

The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.

Hence, the test chemical was considered to be not sensitizing to skin .