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EC number: 218-441-4 | CAS number: 2152-64-9
Skin sensitisation
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 reviwed 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:
- 2 007
- Bibliographic source:
- Journal of Cosmetic Science, 58, no. 3 (2007): 209-214
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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:
- not specified
Test material
- Reference substance name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- EC Number:
- 208-953-6
- EC Name:
- [4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride
- Cas Number:
- 548-62-9
- Molecular formula:
- C25H30N3.Cl
- IUPAC Name:
- (4-(4,4'-Bis(dimethylamino)benzhydrylidene)cyclohexa-2,5-dien-1-ylidene)dimethylammonium, chloride
- 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
Constituent 1
- 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 chemical
- 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 chemical
- 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).
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