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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- 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
- Limit test:
- no
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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
- 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)
Administration / exposure
- 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 - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 days of gestation; orally administration by gavage on days 6 through 18 of gestation
- Frequency of treatment:
- Frequency of treatment
Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg diet
- Dose / conc.:
- 10 mg/kg diet
- Dose / conc.:
- 20 mg/kg diet
- 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 co
uld 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.
Examinations
- Parental animals: Observations and examinations:
- 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 co
uld 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.
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 - Litter observations:
- yes
- Postmortem examinations (parental animals):
- yes
- Postmortem examinations (offspring):
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 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 - Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- < 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- reproductive performance
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- < 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- clinical signs
- other: scheletal malformations
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
At all
three doses there were significant increases in preimplantation losses, primarily due to early resorption of fetuses
and decreases in the number of living fetuses.
Applicant's summary and conclusion
- Conclusions:
- At all
three doses there were significant increases in preimplantation losses, primarily due to early resorption of fetuses
and decreases in the number of living fetuses.
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