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EC number: 224-618-7 | CAS number: 4430-18-6
- 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
Endpoint summary
Administrative data
Description of key information
According to the key studies results (Klimisch 1, GLP compliant study, OECD Guideline 408 method), the main adverse effect was an increase of Activated Partial Thromboplastine. Hence the No Observed Adverse Effect Level was defined as 200 mg/kg bw/day in rats exposed to the test item Jarocol Violet 43, according CLP classification.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two subchronic ( 90 days) studies were availables for repeated dose toxicity by oral routes on rats. They were considered as Klimisch 1 and key studies (GLP compliant, OECD Guideline 408 method).
-In the first key study (1994, Goldfain, Klimisch 1, GLP) rats received the test item by gavage at 0, 50, 200 or 800 mg active dye/kg/day in 5 ml/kg for 13 weeks. Evaluations and measurements included mortality, daily clinical observations, weekly body weight and food intake, ophthalmoscopy, haematology, blood clinical chemistry and urinalysis. At the end of the dosing period, surviving animals were killed and subjected to macroscopic examination, selected organs were weighed, and organs/tissues were preserved. Microscopic examination was performed for specified tissues/organs from all decedent rats, control and high dose rats killed at the end of the study, as well as for gross anomalies, lungs, liver and kidneys from all animals in each key study.
Acid Violet 43 induced ptyalism at all dose levels and increase in activated partial thromboplastin time at 800 mg/kg/day. Colouration of different tissues and/or organs were also noted at all dose levels and attributed to the staining properties of the test substance. The No Observed Adverse Effect Level of the Acid VIolet 43 was defined as 200 mg/kg/day in rats treated by oral gavage in this study.
-In the second key study (Hamman, Klimisch 1, GLP, 2000) rats received the test item by gavage at 0 (vehicle, 1% aqueous solution of carboxymethylcellulose), 100, 300 or 1000 mg/kg/day at a dosing volume of 10 ml/kg for 13 weeks.Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) of test substance Jarocol Violet 43 was defined as 300 mg of test material/kg/day on repeated toxicity (gavage) on rats for 90 day period of treatment according to the APTT Activated Partial Thromboplastin Time increased activity in the high dose level group.
-Two other studies were available in order to assess the potential dermal dose toxicity of the Acid Violet 43(Klimisch 3, no GLP-compliant, no guideline followed, Shaffer, 1965 and 1966). In one study, guinea pig were exposed to the test item dermally during three weeks and in the second, rabbit were exposed dermally during three months at 0.1% and 1% of the substance in formulation. However, the two methods had some significant deficiencies and did not follow standard method. This studies cannot be used for classification.
Justification for classification or non-classification
According the two key studies results (Klimisch 1, GLP compliant study, OECD Guideline 408 method), the main adverse effect was an increase of Activated Partial Thromboplastine Time in high doses levels (1000 mg/kg/day and 800 mg/kg/day). Hence the No Observed Adverse Effect Level (NOAEL) was defined as 200 mg/kg bw/day in rats exposed to the registered item Jarocol Violet 43. No STOT classification was applied.
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