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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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Short description of key information:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if a pre-natal developmental toxicity study (Annex IX, 8.7.2) or a two-generation reproductive toxicity study (Annex IX, section 8.7.3) is available.
Effects on developmental toxicity
Description of key information
The outcomes from the rabbit study provide evidence that Malachite Green may cause developmental toxicity and therefore classification is justified, supporting the current classification Repr 2, H361d
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, no guidelines followed, poorly details on test conditions 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
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Malachite Green was administrated to Rabbits by oral gavage. Thalidomide was used as positive control and untreated animals as untreated control.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- ANIMALS TESTED
- Specie: Oryctolagus cuniculus
- Source: commercial laboratory supplier Scott Rabbit Products, Langley, Washington
- Age at study initiation: time-pregnant
- Housing: all animals were housed individually
- Diet: Purina Laboratory Rabbit Chow supplemented by fresh greens
- Water: water ad libitum
CONTROL
- Group: two control group were used: one untreated and one like positive control (treated by Thalidomide, a known teratogen) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- DIET
- Dose: 5, 10, 20 mg/kg
- Solution: Malachite Green was administrated as an aqueous solution.
- Administration: orally by gavage on days 6 through 18 of gestation
- N. initial animals: 20
POSITIVE CONTROL SOLUTION
- Solution: thalidomide was used as a positive control
- Preparation: Thalidomide was prepared as a suspension in corn oil
- Dose: 150 mg/kg - Duration of treatment / exposure:
- 18 days of gestation; orally administration by gavage on days 6 through 18 of gestation
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
5, 10, 20 mg/kg
Basis:
nominal in diet
Malachite Green solution - Remarks:
- Doses / Concentrations:
150 mg/kg
Basis:
nominal in diet
Positive control - No. of animals per sex per dose:
- At dose 5 mg/kg 16 animals; at 10 mg/kg 21; at 20 mg/kg 16.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- PRELIMINARY TEST
Consequently, doses of 2, 50, and 75 mg/kg were selected to determine the maximum dose to be used with rabbits. Three young, nonpregnant adult New Zealand white rabbits were dosed daily for 13 days in each treatment. Data from this limited study indicated that nonpregnant female rabbits could tolerate 13 consecutive daily doses of 50 mg/kg of Malachite Green. Stanford Research Institute experience has been that pregnant rabbits are much more sensitive to drugs than nonpregnant ones so 20 mg/kg was selected as the maximum level to be used in the teratology study. - Maternal examinations:
- GENERAL SIGN OF TOXICITY: Yes, daily
BODY WEIGHT: Yes
- Time schedule for examinations: were recorded gestation days 0, 6, 9, 12, 15 and 18 and one day 29
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Examination: on day 29 the animals were sacrificed and progeny were delivered by caesarean section. During delivery, all resorptions in each doe were recorded.
OTHER:
Young were thoroughly examined at delivery, weighed and incubated for 24 hours. During incubation they were observed hourly for viability during the first 4 hours and again at 24 hours - Fetal examinations:
- - External examinations: Yes
- Skeletal examinations: Yes
- Visceral examination: Yes - Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Treated adult animals were consistently lower in average total body weight than the untreated controls at the end of the study, but there were no overt signs of toxicity. - Remarks on result:
- other: See report below
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Foetal toxicity was evident in the reproductive performance of does treated with Malachite Green (MG). At all three dosage levels of MG, there were significant increases in pre-implantation losses and in the ratio of dead implants to total implants and decrease in the number of living fetuses (P = 0.05). Early resorption accounted for most of the dead implants.
At the time of caesarean section mean body weights of progeny were significantly less in the thalidomide positive control and 5 mg/kg MG groups than in the untreated controls. Weights of foetuses from the 20 mg/kg MG group were also significantly lighter, but the difference was not as extreme.
Significant effects were observed in all three types of anomalies: gross, visceral and skeletal. Groups treated with 5 and 20 mg/kg MG showed significant differences from control animals in skeletal deviations. All treated groups showed significantly more progeny with deviations than were observed in the controls. Although delayed ossification is not an anomaly, this response was observed in varying ratios among all MG treated lots. - Dose descriptor:
- LOAEL
- Effect level:
- > 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Malachite Green produced significant tetratological affects at all levels of treatment at dose as low as 5mg/kg. Abnormalities noted in rabbits were anomalies most frequently involved the skeleton, liver, heart, and kidneys.
- Executive summary:
Malachite Green Oxalate caused significant developmental abnormalities when administered to pregnant New Zealand whiter rabbits Oryctolagus cuniculus. All dose levels affected foetal development of rabbits. At the dosages given, the incidence of anomalies caused by Malachite Green was about half that observed in thalidomide-treated positive controls and two to three times that in untreated controls.
Reference
During treatment with malachite green, the does showed a greatly reduced intake of dry food. This reduced food consumption is believed to have been related to the chemical treatments rather than the result of an incomplete diet.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 5 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
An old study on Malachite Green (MG) conducted in rabbits provides indication of developmental toxicity, evidenced by an increase in the number of resorptions at doses that did not cause significant maternal toxicity (Meyer et al., 1983). MG produced significant tetratological affects at all levels of treatment at dose (5, 10 and 20 mg/kg bw) as low as 5 mg/kg. Abnormalities noted in rabbits were most frequently involved the skeleton, liver, heart, and kidneys.
Although no evidence of developmental toxicity was found in rats in Reynolds reports (1991, 1992), which demonstrated the absence of effects of oral administration (by gavage) of MG to pregnant rats during the period of organogenesis at a dose levels of 2, 10, 50 and 100 mg/kg bw/day on litter and foetal responses, the outcomes from the rabbit study provide evidence that MG may cause developmental toxicity and therefore classification is appropriated, supporting the current classification Repr 2, H361d.
The actual classification of Malachite Green as H361d (Suspected of damaging the unborn child) can be accepted with no further investigation for Malachite Green Acetate.
Toxicity to reproduction: other studies
Additional information
Fertility
No data available. No classification proposed
Developmental toxicity
The developmental toxicity of Malachite Green (MG) has been investigated in two species, rat and rabbit. No evidence of developmental toxicity was evident in rats at dose levels causing maternal toxicity (increased mortality and reduced bodyweight); nevertheless the older study on rabbits provides some indication of possible developmental toxicity, evidenced by an increase in the number of resorptions at doses that did not cause significant maternal toxicity.
Although the inconsistent results found on rats and rabbits, the outcomes of the rabbit study provide evidence that MG may cause developmental toxicity and therefore classification is appropriated, supporting the current harmonized classification Repr. Cat. 2;
H361d
.Justification for classification or non-classification
The findings from the rabbit study provide evidence that malachite green may cause developmental toxicity and therefore classification is justified, supporting the current harmonized classification Repr.2 H361d
The actual classification of Malachite Green as H361d (Suspected of damaging the unborn child) can be accepted with no further investigation for Malachite Green Acetate.
Additional information
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.
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