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Diss Factsheets
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EC number: 241-922-5 | CAS number: 18015-76-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- 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
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Details about test substance composition, test method and procedures are missing. Read across from a similar substance which has the same main component and with a different counter ion that does not influence the characteristics related to the specific end-point.
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact-group sensitization to triphenylmethane dyes.
- Author:
- Bielicky T., Novak M
- Year:
- 1 969
- Bibliographic source:
- Arch Derm - vol 100, Nov 1969
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- survey
- Principles of method if other than guideline:
- The possibility of cross-sensitization of some triphenylmethane dyes was evaluated by patch test. Malachite Green at 2 % in water was administrated to 11 patients. The patch tests were put on for 20 to 24 hours and were evaluated for six to seven days.
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Malachite Green
- IUPAC Name:
- Malachite Green
Constituent 1
Method
- Type of population:
- general
- Subjects:
- 11 patients: test was executed on 9 patients, in two cases was not done
- Route of administration:
- dermal
- Details on study design:
- Patients with clinical signs of contact sensitivity to therapeutically used TPM dyes were patch tested.
TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Concentrations: Malachite Green at 2 % in water.
- Exposure period: from 20 to 24 hours
- Observation period: for 6 to 7 days
EXAMINATIONS
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 + + +
Results and discussion
- Results of examinations:
- The simultaneous positive reactions after crystal violet (contained in gentian violet), Brilliant Green, and Malachite Green in the majority of sensitive patients indicate the possibility of cross-sensitization. Malachite Green was not therapeutically used in our patients and this supports the opinion that there was no isolated sensitization to the individual dyes. It is not easy to decide which of the two remaining dyes was the primary sensitizer. If we support the contention that the reaction to the primary sensitizer is stronger, then for patients 8, 10, and 11 the brilliant green was the primary sensitizer and in patient 3 the crystal violet.
Applicant's summary and conclusion
- Conclusions:
- Patch test of Malachite Green resulted in same case positive and in others negative: 6 positive cases on 9 patients tested.
- Executive summary:
In 11 patients with eczema localized mainly on the legs, 11 cases of sensitization were observed to brilliant green. In these cases, a simultaneous sensitivity to gentian violet (crystal violet) was found in eight and to Malachite Green in six patients. Patch tests with various triphenylmethane (TPM) dyes have shown the possibility of cross-sensitization between crystal violet (contained in gentian violet), brilliant green, and Malachite Green. The probable determinant groups of sensitization are -N(CH3)2 or -N(C2H5)2in the para position of the benzene ring structure.
Malachite Green was not therapeutically used in patients and this supports the opinion that there was no isolated sensitization to the individual dyes. It is not easy to decide which of the two remaining dyes was the primary sensitizer. If it is supported that the reaction to the primary sensitizer is stronger, for patients 8, 10, and 11 the brilliant green was the primary sensitizer and in patient 3 the crystal violet.
Conclusion
Patch test of Malachite Green resulted in same case positive and in others negative: 6 positive cases on 9 patients tested.
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