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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
Endpoint summary
Administrative data
Description of key information
Not skin irritating
Eye Dam. 1, H318
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- not specified
- 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. - 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. - 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. - 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).
Reference
.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION/CORROSION
White Newzeland rabbits were used to test Malachite Green for the skin irritation potential: after application of 500 µl rabbits were observed for 1h, 24h, 48h, 72 hours up to 8 days. Erythema was not identified because the skin resulted to be colourful, while no oedema was found. However, the rabbit skin was dry and atrophied, even after 8 days of observation, thus the substance was evaluated as strong irritating (DyStar Colours Distribution GmbH, 1982). Despite the experiment was performed according to accepted testing guideline, details about the tested substance composition are missing. The effects recorded were not fully evaluable and the recovering has been evaluated after only 8 days instead than 21 days. Furthermore, dryness is not clearly an irritating effect attributable to the test substance. Because of the lacking of relevant information from the assessment point of view, the study has been disregarded.
As mentioned into the IUCLID section 7.2.3, Clemmensen et al. (1984) tested the dermal acute toxicity of Malachite Green (MG) oxalate (purity > 90 %). The limited information available suggests application of a 20 % suspension of Malachite Green oxalate (2000 mg/kg) does not cause skin irritation: it did not produce visible erythema or oedema on either rats or guinea pigs.
In conclusion, a classification of Malachite Green as skin irritating would be not justified.
EYE/IRRITATION
Clemmensen et al. (1984) tested eye irritation by Malachite Green Oxalate. Instillation of 8 % aqueous solution produced market oedema, substantial discharge and slight hyperemia of the conjunctiva, which disappeared after 24 h in two out of three rabbits. Treatment with fine crystals of Malachite Green produced a totally opaque corneas, bright red and oedematous conjunctivae up to four days. 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 Clemmensen et al. study outcomes have been reviewed and the effects occurring in the rabbit treated with fine crystals were judged assufficient to support the current classification: Xi; R41 (corresponding to Eye Dam. 1, H318 of the CLP Regulation (EC 1272/2008).
An epidemiological investigation was performed in 2005: eyewash fluid collected from the patients exposed to the colors was also subjected for analysis. The study was further extended to evaluate the corneal penetration of Malachite Green using goat cornea in perfusion chamber. In was concluded that the usage of Malachite Green cause severe form of ocular manifestations upon its exposure. Trans-corneal penetration studies revealed lack of detectable concentration of Malachite Green in the aqueous humour at the studied concentration showed that it is unlikely to cause intraocular toxicity (Velpandian, 2007).
Furthermore, literature sources reports a case in which 1 % solution of Malachite Green resulted in destructive keratinis with hypopyon (hypopyon is pus in the eye; it is a leukocyte exudate, seen in the anterior chamber, usually accompanied by redness of the conjunctiva) and terminated in bilateral blindness due to corneal opacification. In the same book, Malachite Green is reported to cause injury ranging in severity from conjunctiva oedema, hyperemia, purulent discharge to total opacification of corneal stroma (Grant, 1974)
Despite the DyStar Colours Distribution GmbH (1982) study reports conclusions that are in agreement with the abovementioned information, it cannot be considered for the classification and labelling pourpose. The experiment is scientifically acceptable, nevertheless details about the tested substance composition are missing; because of the lacking of relevant information, the study has been disregarded.
In conclusion, all available information confirm that Malachite Green cause severe irritation.
REFERENCE
Grant, W.M. 1974. Toxicology of the Eye. 2nd ed., pp. 430-433. Charles S. Thomas, Springfield, IL. p.431
Effects on eye irritation: highly irritating
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
Based on the available information, a classification of Malachite Green as skin irritating would be not justified.
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce serious eye damage are classified in Category 1. The available information shows that Malachite Green can cause serious eye damage.
In conclusion, the substance is not classified for the skin irritation. On the contrary, it is classified as Eye. Dam. 1 (H318), according to the CLP Regulation (EC 1272/2008).
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