Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 255-288-2 | CAS number: 41272-40-6
- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP study, aged study Read across from a similar substance which has the same main component and with a different counter ion that doesn't influence the characteristics related to the specific end-point
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological studies on malachite green: A triphenylmethane dye
- Author:
- Clemmensen S., Jensen C., Jensen N., Meyer O., Olsen P., Wurtzen G.
- Year:
- 1 984
- Bibliographic source:
- Arch Toxico l1984) 56: 43-45
Materials and methods
- Principles of method if other than guideline:
- For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Malachite Green Oxalate
- IUPAC Name:
- Malachite Green Oxalate
- Details on test material:
- - Name of test material: Malachite Green Oxalate
- Source: Dansk Orredforder A/S, Brande, Danmark
- Structure: (C23H25N)2 (COO)2 X 2 (COOH)2
- Analytical purity: > 90% detected by TLC
Constituent 1
Test animals
- Species:
- other: rat and guinea pig
- Strain:
- other: Wistar and Ssc
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
RATS
- Strain: Wistar rats, Mol: WIST (SPF)
- Weight at study initiation: 170-250 g
- Source: from Molllegard Breeding Centre (L1. Skensved, Denmark)
GUINEA PIG
- Strain: Ssc, AL
- Source: Statens Serumininstitut, (Copenhagen, Denmark)
- Weight at study initiation: 300 g
All were given food and water freely except 16 h before gavage.
For rats
- Temperature: kept at 22 ± 1°C
- Humidity: 60 ± 10%
- Light: from 21.00 to 09.00 with air changes eight times/h.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied: Aqueous solution
- Concentration: MGH at 20% - Duration of exposure:
- 14 days
- No. of animals per sex per dose:
- Groups of five animals of either sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage (Acrylastic, Beiersdorf AG, FRG)
Observation period: 1, 2, 3, and 5 h after dosing and each day for 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
No signs of systemic toxicity were observed after occlusive dermal application of 2000 mg/kg. As a 20% suspension of Malachite Green did not produce visible erythema or oedema on either rats or guinea pigs; authors hadn't deemed it meaningful doing a rabbit skin irritation study. Similarly, within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Acute Dermal Toxicity: no signs of systemic toxicity were observed after occlusive dermal application of 2000 mg/kg
- Executive summary:
Rats ang guinea pig were tested for dermal acute toxicity. For skin application a site of 35 cm^2 was clipped 3 h before administration and the site covered by four-ply gauze and an elastic bandage.
No signs of systemic toxicity were observed after occlusive dermal application of 2000 mg/kg. As a 20% suspension of Malachite Green did not produce visible erythema or oedema on either rats or guinea pigs; authors hadn't deemed it meaningful doing a rabbit skin irritation study. Similarly, within the conditions of the guinea pig maximisation test no effects could be seen on controls or treated animals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
