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Diss Factsheets
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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
The registered item Acid Violet 43 is not classified as acute oral hazard according to the key study (GLP, OECD Guideline 401 followed, Klimisch 2) and the CLP regulation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Four studies were available for acute oral toxicity assay. Three were performed on rats by oral gavage and the last was performed on dogs which is unrelevant for CLP classification. However one was considered as key study (Klimisch 2, OECD guideline 401, Rondot 1984).
- In this study, the registered substance was administered orally on male and female rats (2 for preliminary study and 5 for the main study per sex) per dose group (gavage) at 1000, 2000 and 5000 mg/kg bw in preliminary study and 0 and 5000 mg/kg bw were used for the main study (limit test). The Acid Violet 43 was in suspension in deionized water. The registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage.
-In the two others study (considered as supporting study due to uncomplete informations, Klimsch 3), rats were administered with test item at 464, 2150, 4640 mg/kg and no mortality occured (Scala, 1962, No GLP, non standard method). The second supporting study (Coquet, 1976, Non GLP compliant, non standard method) showed mortality at 10 000 mg/kg bw to 20 000 mg/kg bw in rats by oral gavage, the LD50 value was defined as 13 000mg/kg bw for this study.
Justification for classification or non-classification
According the results of the key study, the LD50 value was considered as greater than 5000 mg/kg bw. According to CLP regulation, the register substance Acid Violet 43 was not classified for Acute Oral Toxicity.
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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