Registration Dossier
Registration Dossier
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EC number: 209-886-5 | CAS number: 596-49-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- An animal model assessment of common dye-induced allergic contact dermatitis
- Author:
- JOE DINARDO, Raleigh N, C; and ZOE DIANA DRAELOS
- Year:
- 2 007
- Bibliographic source:
- j. Cosmet. Sci.., 58, 209-214 (May/June2007)
Materials and methods
Test guideline
- Qualifier:
- according 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: a modified Buehler and Klecak method
Test material
- Reference substance name:
- Methylrosanilinium chloride
- IUPAC Name:
- Methylrosanilinium chloride
- 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
- IUPAC Name:
- N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Test material form:
- other: solid
- Details on test material:
- - Name of test material : Basic Violet 3
- Molecular formula:C25H30N3Cl
- Molecular weight: 407.986 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChI: 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
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- induction concentration : 10%
challenge concentrations: 10.0%, 5.0%, and 2.5%
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- induction concentration : 10%
challenge concentrations: 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
- 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: no data
- Site: shaved left flanks of ten albino guinea pigs
- Concentrations: 100%,50%, and 25%
- Evaluation (hr after challenge): 24 hour and 48 hours - Challenge controls:
- no data
- 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)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10.0%, 5.0%, and 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not sensitizing
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10.0%, 5.0%, and 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not sensitizing.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10.0%, 5.0%, and 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not sensitizing
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10.0%, 5.0%, and 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: not sensitizing.
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:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance Basic violet 3 (CAS No: 548-62-9) was considered to be non -sensitizing in guinea pig by modified Buehler and Klecak method.
- Executive summary:
Skin sensitization test for Basic violet 3(CAS No: 548-62-9) was conducted inguinea pig using modified Buehler and Klecak method for open Epicutaneous testing.
For the induction phase, the left flanks of 10 albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test 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 (100%,50%, and 25% 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 Basic violet 3(CAS No: 548-62-9) was considered as not sensitizing to the guinea pigs skin.
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