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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
Scientific opinion on the safety and efficacy of E133 as a feed additive for cats and dogs
Author:
EFSA
Year:
2013
Bibliographic source:
EFSA Journal, 2013

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 207 human volunteers
GLP compliance:
not specified
Type of study:
other: Human maximization 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):Brilliant Blue FCF aluminum lake- IUPAC Name: Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt- Molecular formula:C37H36N2O9S3.xAl- Molecular weight:775.8764 g/mol- Substance type:Organic- Physical state:Solid

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
207 human volunteers were used

Study design: in vivo (non-LLNA)

Induction
Route:
other: Not specified
Vehicle:
water
Concentration / amount:
5 % aqueous solution
Day(s)/duration:
3 week
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Not specified
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
207 human volunteers
Details on study design:
RANGE FINDING TESTS: MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 9 - Exposure period: Not specified - Test groups: 207 human volunteers - Control group: Not specified - Site: Not specified - Frequency of applications: three times per week for three weeks - Duration: 3 weeks - Concentrations: 5% aqueous solution B. CHALLENGE EXPOSURE - No. of exposures: Not specified - Day(s) of challenge: Not specified - Exposure period: Not specified - Test groups: 207 human volunteers - Control group: Not specified - Site: Not specified - Concentrations: 5% aqueous solution - Evaluation (hr after challenge): Not specified OTHER: challenge treatment was followed after 12 days of induction treatment
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
5% aqueous solution
No. with + reactions:
0
Total no. in group:
207
Clinical observations:
No skin irritation or reaction was observed
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin irritation or reaction was observed

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
No local reactions (irritation or sensitisation) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical.Thus it was considered that test substance was not sensitizing to human skin.
Executive summary:

A skin sensitization study was performed to evaluate the skin sensitization potential of the test chemical on 207 human volunteers.

5% aqueous solution pf the test chemical was applied during induction and challenge process. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days. No local reactions of sensitisation was seen in 207 human volunteers

Thus it was considered that test substance was non sensitization to human skin.