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Reaction mass of Disodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](hydroxy)chromate(2-) and Trisodium [3-{[4-chloro-2-(hydroxy-kO)-5-methoxyphenyl]diazenyl-kN2}-4-(hydroxy-kO)naphthalene-2,7-disulfonato(4-)](dihydroxy)chromate(3-)
EC number: 953-115-1 | CAS number: -
- 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 oral median lethal dose (LD50) of test item is 7638 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: 50 Tif. RAI rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet: NAFAG, Gossau SG, rat food) ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- polyethylene glycol (PEG 400)
- Doses:
- 3170, 4640, 6000, 7750 and 10000 mg/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- The LD50 was calculated by probit analysis method (Goulden A. Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 7 638 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 6 637 - < 8 790
- Mortality:
- No mortality was found at 3170 mg/kg dose. One animal each was died at 4640 and 6000 mg/kg dose. 6 animal at 7750 mg/kg and 8 animals at 10000 mg/kg dose.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days
- Gross pathology:
- No substance related gross organ changes were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.
- Executive summary:
An acute oral toxicity study with FAT 20044/A was carried out in rats. The dose level used in the study was 3170, 4640, 6000, 7750 and 10000 mg/kg. 5 rats per sex per dose were administered with test item. There were no mortality was found at 3170 mg/kg dose. However, one animal each was died at 4640 and 6000 mg/kg dose and 6 animal died at 7750 mg/kg and 8 animals at 10000 mg/kg dose. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. There were no substance related gross organ changes were seen. So based on the study results, oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Quality of whole database:
- Comparable to standard acute toxicity study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute Oral Toxicity:
An acute oral toxicity study with FAT 20044/A was carried out in rats. The dose level used in the study was 3170, 4640, 6000, 7750 and 10000 mg/kg. 5 rats per sex per dose were administered with test item. There were no mortality was found at 3170 mg/kg dose. However, one animal each was died at 4640 and 6000 mg/kg dose, respectively, and 6 animal died at 7750 mg/kg and 8 animals at 10000 mg/kg dose. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days. There were no substance related gross organ changes were seen. So based on the study results, oral median lethal dose (LD50) of FAT 20044/A is 7638 mg/kg.
Acute Inhalation Toxicity:
Currently no study to assess acute inhalation toxicity of Acid Blue 156 is available. However, low vapour pressure owing to high melting point (>350 °C), the substance is considered to have low volatility. Synthesis of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is unlikely. The chemical showed low toxicity potential in the available acute oral (LD50>7000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Blue 156 via inhalation route.
Acute Dermal Toxicity:
Currently no study to assess the acute dermal toxicity of Acid Blue 156 is available. However, this substance found to have high molecular weight 600 g/mol, this indicates that partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral (LD50>7000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Acid Blue 156 via dermal route and hence, acute toxicity testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Based on the observed LD50 of >7000 mg/kg bw in the acute oral toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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