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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The experiment is scientifically acceptable, nevertheless details about test method and procedures are missing.
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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- EC Number:
- 241-922-5
- EC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Cas Number:
- 18015-76-4
- Molecular formula:
- C23H25N2 x C2HO4
- IUPAC Name:
- 4-{[4-(dimethylamino)phenyl](phenyl)methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium hydrogen oxalate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: CPH
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: from Statens Sevlmlnstimt, (Copenhagen, Denmark).
- Weight at study initiation: 2.7 kg.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 100 µl.
- Application: aqueous solution (76 mg/kg) was deposited in the lower conjunctival sack of the left eye. - Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- Three rabbits + one
- Details on study design:
- Three rabbits were treated with 8 % aqueous solution; a further single rabbit was treated with fine crystals (particle size 60-90 µm).
TOOL USED TO ASSESS SCORE: examinatious carried out with an ophthalmoscope and 1 % sodium fluorescein solution.
Results and discussion
In vivo
Results
- Remarks on result:
- other: results are reported in the other sections
- Irritant / corrosive response data:
- Instillation of 8 % aqueous solution produced marked edema, substantial discharge and slight hyperemia of the conjunctiva which disappeared after 24 h in two out of three rabbits. No effect on cornea or iris was observed and all were fully restituted after 8 days.
The rabbit treated with fine crystals showed a totally opaque cornea and bright red and edemateous conjunctivae which remained for a forthnight.
Any other information on results incl. tables
.
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Dam. 1 (H318), according to the CLP Regulation (EC 1272/2008)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Eye Dam. 1, H318
- Executive summary:
100 µl of Malachite Green Oxalate was deposited in the lower conjunctival sack of the left eye while the fight eye served as a control. Treatment and observations were in accordance with the OECD guidelines (1981), and examlnatious carried out with an ophthalmoscope and 1 % sodium fluorescein solution. Instillation of 8 % aqueous solution produced marked edema, substantial discharge and slight hyperemia of the conjunctiva which disappeared after 24 h in two out of three rabbits. No effect on cornea or iris was observed and all were fully restituted after 8 days.
A single rabbit was treated with fine crystals (particle size 60-90 µm) which produced a totally opaque cornea and bright red and edemateous conjunctivae which remained for a forthnight.
Conclusion
An harmonized classification and labelling (C&L) has already been approved for Malachite Green chloride (EC: 209-322-8) and oxalate (EC: 219-441-7) salts. The classifications have been discussed by Commission of the European Communities and the related information was presented in ECBI/54/02 report, 18th July, 2002 (Health and Safety Executive, UK. 2005). In this context, the current study outcomes have been reviewed and the effects occurring in the rabbit treated with fine crystals were judged as sufficient to support the current classification: Xi; R41 (corresponding to Eye Dam. 1, H318 of the CLP Regulation (EC 1272/2008).
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