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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 journal

Data source

Reference
Reference Type:
publication
Title:
An animal model assessment of common dye-induced allergic contact dermatitis.
Author:
JOE DINARDO, Raleigh, NC and ZOE DIANA DRAELOS
Year:
2007
Bibliographic source:
Journal of Cosmetic Science, 58, no. 3 (2007): 209-214

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study was performed for test chemical in guinea pigs by using modified Buehler and Klecak method.
GLP compliance:
not specified
Type of study:
other: a modified Buehler and Klecak method
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 : Disperse violet 4
- Molecular formula: C15H12N2O2
- Molecular weight: 252.272 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: c12c(C(c3ccccc3C1=O)=O)c(ccc2NC)N
- InChI: 1S/C15H12N2O2/c1-17-11-7-6-10(16)12-13(11)15(19)9-5-3-2-4-8(9)14(12)18/h2-7,17H,16H2,1H3

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10% (0.1mL)
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
10.0%, 5.0%, and 2.50%
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hour
- Test groups: 10
- Control group: no data
- Site: shaved left flanks of ten albino guinea pigs over a 1.8-cm circular area.
- Frequency of applications: three times weekly (Monday, Wednesday Friday) for three consecutive weeks.
- Duration: 3 weeks
- Concentrations:10%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Two week rest period
- Exposure period: 24 hours
- Test groups: 10
- Control group:
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 10.0%, 5.0%, and 2.50%
- Evaluation (hr after challenge): 24 hour and 48 hours
Positive control substance(s):
yes
Remarks:
0.5% DNCB

Results and discussion

Positive control results:
The positive DNCB (2, 4-dinitrochlorobenze) control at the 0.5% induction /challenge concentration elicited positive response in all animals tested.

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10.0%, 5.0%, and 2.50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No erythema/edema was observed after 24 and 48 hours post-application.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No erythema/edema was observed after 24 and 48 hours post-application

Any other information on results incl. tables

All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale

 0 = no reaction,

 1 = slight reaction,

2 = moderate reaction and

3 = severe reaction.

A positive reaction was defined as an erythema/edema

value during the challenge phase of at least one skin grade higher than during the last induction phase

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test substance was considered to be non -sensitizing in guinea pig by modified Buehler and Klecak method.
Executive summary:

Skin sensitization test for test chemical was conducted in guinea pig usingmodified Buehler and Klecak method for open Epicutaneous testing.

 

For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the test material wasapplied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the material over a 1.8-cm circular area.

 

Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentration (10.0%, 5.0%, and 2.50%of the induction concentration).

 

Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.The test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale (0 = no reaction, 1 -- slight reaction, 2 = moderate reaction, 3 = severe reaction. A positive reaction was defined as an erythema/edema value during the challenge phase of at least one skin grade higher than during the last induction phase.

 

 No erythema/edema was observed after 24 and 48 hours post-application. Hence the test substance was considered as not sensitizing to the guinea pigs skin.