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EC number: 235-468-7 | CAS number: 12237-62-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 42535:3.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- 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 publication .
Data source
Reference
- Reference Type:
- publication
- Title:
- An animal model assessment of allergic contact dermatitis of test chemicals
- Author:
- DINARDO et.al
- Year:
- 2 007
- Bibliographic source:
- JOURNAL OF COSMETIC SCIENCE,2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: modified Buehler and Klecak method
- Principles of method if other than guideline:
- Modified Buehler and Klecak method was performed to evaluate the dermal sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Currently no LLNA study was available for assessment
Test material
- Reference substance name:
- 8004-87-3
- EC Number:
- 616-846-4
- Cas Number:
- 8004-87-3
- Molecular formula:
- C24H28ClN3
- IUPAC Name:
- 8004-87-3
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): C.I. Basic Violet 1
- Molecular formula: C24H28ClN3
- Molecular: 393.95 g/mol
- Substance type: Organic
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino guinea pigs
- 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%
- Day(s)/duration:
- 24 and 48 hours exposure for 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 10.0%, 5.0%, and 2.5%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 animals
- Details on study design:
- Details on study design
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period:48 hour
- Test groups: 10
- Control group: no data
- Site: the left flanks of ten albino guinea pigs were shavedand the test material applied three times weekly( Monday,Wednesday,Friday)for three consecutiv weeeks. Each animal received 0.1 ml of the dye test material 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 hour
- Test groups: 10
- Control group: No data available.
- Site: right flank of each guinea pig was shaved and test material applied on it.
- Concentrations: 10.0%, 5.0%, and 2.5%
- Evaluation (hr after challenge): 24 hour and 48 hours post-application
Other – 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. - Challenge controls:
- No data available.
- Positive control substance(s):
- yes
- Remarks:
- DNCB (2,4-dinitrochlorobenze)
Results and discussion
- Positive control results:
- The positive control 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:
- other: Challenge
- 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:
- No sensitization reaction observed.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: challenge
- 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:
- No skin sensitization reaction observed.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Allergic contact dermatitis of dyes
Induction concentration in propylene glycol |
Challenge concentration in propylene glycol* |
||
10% |
5% |
2.5% |
|
10% |
Negative |
Negative |
negative |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- No erythema/edema was observed after application of test material.The test result was observed to be negative for the test substance. Therefore, the test chemical was considered to be not sensitizing to the skin of guinea pigs.
- Executive summary:
A modified Buehler and Klecak method for open epicutaneous testing[OET] was performed to assess the sensitization potential of the test chemical.The test chemical was tested at an induction concentration of 10% and challenge concentrations of 10.0%, 5.0%, and 2 .5% in propylene glycol.During the induction phase, the left flanks of ten 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 concentrations in propylene glycol(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions. All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale.A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases. No erythema/edema was observed after application of test material.The test result was observed to be negative for the test substance. Therefore, the test chemical was considered to be not sensitizing to the skin of guinea pigs.
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