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Diss Factsheets
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EC number: 221-518-5 | CAS number: 3130-19-6
- 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
Oral Toxicity: Read-across to structurally similar substance, Kern (1999)
The results of this study indicate that the LD50 of the test material was found to be approximately 5000 mg/kg in fasted male and female albino rats when administered once orally via gavage. Based on these results, it was not necessary to classify the test material according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.
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
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral Toxicity: Read-across to structurally similar substance, Kern (1999) (Key Study)
The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 and EPA OPPTS 870.1100, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
In a study conducted by Kern (1999), the acute oral toxicity of the test material was evaluated in a single-dose study in rats. The test material was administered once orally via gavage to groups of five male and five female fasted albino rats at dose levels of 2959 and 5000 mg/kg. The animals were observed at regular intervals for up to 14 days following administration to ascertain any changes in body weight or clinical behaviour. At termination of the study after 14 days, the animals were necropsied and any changes in the major organs was recorded.
3 males and 2 females in the 5000 mg/kg group died within six days of dosing. Mortality was 0/10 and 5/10 for the 2959 and 5000 mg/kg groups, respectively. Clinical findings were noted in both dose groups during the first week of the study with observations including various discoloured areas due to discharges/excretions, hypoactivity and/or impaired muscle coordination. Animals in the higher dose group were noted with decreased defecation, decreased urination, laboured respiration and/or convulsions. All animals appeared normal by day 6 and throughout the remainder of the study. Three animals that died were noted with gastric abnormalities. There were no other internal gross necropsy findings for animals found dead.
The LD50 of the test material was found to be approximately 5000 mg/kg in fasted male and female albino rats when administered once orally via gavage. Since the median lethal dose estimate was much higher than the test guideline limit, it was not necessary to classify the test material according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.
Oral Toxicity: Read-across to structurally similar substance, Bucch (1981) (Supporting Study)
In the study conducted by Buch (1981), the acute oral toxicity of Celloxide 2021 was investigated in groups of fasted male and female rats of the Charles River CD strain at dosages within the range 3500 - 5500 mg/kg. The test material was administered at a variable volume-dosage in maize oil on Day 1. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.
Under the conditions of this study the acute oral median lethal dosage (LD50) was greater than 5000 mg/kg. Based on these results, the test material does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.
Supporting Study
The acute oral toxicity of the test material was investigated by dosing to unfasted male rats with dose levels that differed by a factor of 2.0 in a geometric series
Soon after dosing, the rats became sluggish and were unsteady in gait. Deaths occurred by the morning after dosing. At autopsy gross pathological examination disclosed congestion of the lungs and the abdominal viscera. Burned areas were evident on liver surfaces that lay in apposition to stomachs which still contained part of the dose.
Under the conditions of this study the LD50 of the test material was 4.29 mL/kg bw (95 % confidence limits: 3.07-5.98 mL/kg).
Inhalation Toxicity
In accordance with section 8.5.2 of Column 2 of REACH Annex VIII, testing via the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. For the test material, exposure via the inhalation route is unlikely and it is therefore considered justified to omit this study.
Dermal Toxicity
In accordance with column 2 of section 8.5.3 of REACH, the acute dermal toxicity study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute 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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