Registration Dossier
Registration Dossier
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EC number: 947-401-5 | CAS number: -
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-reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Basic Violet dyes
- Author:
- Catherine Diamante et.al
- Year:
- 2 009
- Bibliographic source:
- International Journal of Toxicology, 2009
- Reference Type:
- publication
- Title:
- Contact-Group Sensitization to Triphenylmethane Dyes
- Author:
- Novák M et.al
- Year:
- 1 969
- Bibliographic source:
- Arch Dermatol, 1969
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Patch tests were performed to evaluate the degree of allergic reactions caused by the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
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:
- C25H30ClN3
- IUPAC Name:
- N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride- Common Name: Basic Violet 3- Molecular formula :C25H30N3.Cl- Molecular weight :407.986g/mol- Substance type:Organic - Physical state:Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 2% in water
- Day(s)/duration:
- 20-24 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 2% in water
- Day(s)/duration:
- 20-14 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 11 volunteers
- Details on study design:
- Other: The patch tests were put on for 20 to 24 hours and they were evaluated for six to seven days. Since the skin is colored by the tested dye, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:Itching = ±Isolated papules = +Edema, confluent papules, infiltration= + +Vesicular reaction = + + +
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Positive control substance(s):
- not specified
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2% in water
- No. with + reactions:
- 8
- Total no. in group:
- 11
- Clinical observations:
- itching +; isolated papules +; edema, confluent papules, and infiltration ++; or vesicular reaction+++ was observed
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Patch test responses
Volunteer number | Reactions to the Test chemical |
1 | + |
2 | +++ |
3 | + |
4 | + |
5 | + |
6 | ++ |
7 | - |
8 | + |
9 | - |
10 | - |
11 | ++ |
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitizing
- Conclusions:
- Positive reactions to the test chemical were observed in 8 of the 11 volunteers tested.Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.The test material was considered to be a skin sensitizer.
- Executive summary:
Patch tests were performed to evaluate the degree of allergic reactions caused by the test material
The patch tests were put on for 20 - 24 hours on the skin of 11 volunteers. They were evaluated for six to seven days. Since the skin got colored by the test chemical, it was not possible to evaluate the erythematous reaction. For this reason evaluation was recorded as follows:
Itching = ±
Isolated papules = +
Edema, confluent papules, infiltration= + +
Vesicular reaction = + + +
Positive reactions to the test chemical were observed in 8 of the 11 volunteers tested.
Edema, confluent papules, infiltration were observed in 2 of 11 volunteers; vesicular reaction was noted in 1 volunteer.
The test material was considered to be a skin sensitizer.
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