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 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:
j. Cosmet, Sci 58, 209-214 (May/June2 007)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization test was performed for test chemical Basic Violet 3 in guinea pig by modified Buehler and Klecak method.
GLP compliance:
not specified
Type of study:
other: not specified
Justification for non-LLNA method:
No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):Gentian violet
- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Molecular formula : C25H30N3.Cl
Molecular weight : 407.986 g/mol
- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
Name of test material (as cited in study report): Basic violet 3
- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Molecular formula : C25H30N3.Cl
Molecular weight : 407.986 g/mol
- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid

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, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10.0%, 5.0%, and 2.5%
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:9 times
- Exposure period:
- Test groups: 10
- Control group: yes
- Site: left flank(1.8-cm circular area)
- Frequency of applications: Three times weekly( Monday, Wednesday Friday) for three consecutive weeks
- Duration: 3 weeks
- Concentrations: 0.1ml of 10% solution in PG

B. CHALLENGE EXPOSURE
- No. of exposures:3 different concentration
- Day(s) of challenge: After 2 weeks
- Exposure period: No data available
- Test groups: 10
- Control group: yes
- Site: right flank
- Concentrations: 0.1ml of 10% , 5%, 2.5% in PG
- Evaluation (hr after challenge): 24hr and 48 hr

Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
0.5% 2,4-dinitrochlorobenzene (DNCB) in ethanol

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

Positive control results:
The positive DNCB control at the 0.5% induction/challenge concentration elicited positive response is all animals tested.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1ml of 10% , 5%, 2.5% in PG
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin sensitization reaction was not observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1ml of 10% , 5%, 2.5% in PG
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin sensitization reaction was not observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
The Basic Violet 3 (548-62-9) was considered to be not sensitizing in guinea pig.
Executive summary:

The skin sensitization study of Basic Violet 3 (548-62-9) was performed by Buehler test and the Klecak method for open epicutaneous testing (OET) in 10 guinea pigs.In induction phase, induction given using0.1ml of 10% solution in polyethylene glycol (PG) on left flank (1.8-cm circular area) by topical application for three times weekly ( Monday, Wednesday Friday) for three consecutive weeks. 0.5% 2,4-dinitrochlorobenzene (DNCB) in ethanol used as positive control.

 In challenge phase, After 2 weeks rest period, challenge application given in dose concentration0.1ml of10% , 5%, 2.5% in PG on right flank.Evaluation done 24hr and 48 hr after challenge application. No indication of skin sensitization was observed.Hence it is considered that Basic Violet 3(548-62-9)was not skin sensitizing in guinea pig by Buehler test andthe Klecak method for open epicutaneous testing (OET).