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Diss Factsheets
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EC number: - | 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
Oral (OECD 423), rat (m/f): LD50 (cut-off) > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Acute toxicity
Oral
The acute toxicity of the test substance was determined in a GLP-conform study according to the acute toxic class method (OECD 423), in which two groups of 3 female Wistar rats were exposed to the limit dose of 2000 mg/kg bw of the test substance in sterile water by single gavage application (Holalagoudar, 2012). No mortalities occurred during the study period and clinical signs of toxicity including reduced spontaneous activity, piloerection and half eye-lid closure were only observed in 1 of 6 animals 1 to 4 h after administration of the test substance . Body weight gain was within the normal range of variation for animals of this strain throughout the 14-day study period. Necropsy did not reveal any gross pathological findings in the animals of any step. Based on these experimental results, the LD50 was greater than 2000 mg/kg bw. According to the criteria of OECD guideline 423, the LD50 cut-off is considered to be greater than 5000 mg/kg bw.
Dermal
The acute dermal toxicity of the test substance was investigated in accordance with OECD 402 and in compliance with GLP (Holalagoudar, 2012). The study was performed as a limit test in Wistar rats (5 males and 5 females) at a dose of 2000 mg/kg bw. The test substance was moistened with sterile water and applied to the clipped skin of the test animals for approx. 24 h under semiocclusive conditions. After removal of the test substance, animals were observed for mortality, clinical signs of toxicity and changes in body weight during a 14-day observation period. In addition, the formation of erythema and edema was assessed using the Draize scoring system from Day 2 after application of the test substance up to the end of the study. No treatment-related mortalities occurred, but clinical signs of toxicity including nasal discharge, slightly reduced spontaneous activity and slight piloerection were observed in 2 of 5 males and 3 of 5 females at the beginning of the 14-day observation period. The body weight evolution in all animals was not affected by treatment, except for a slight loss in body weight during the first week of the study in all females. However, this effect was not clearly attributable to treatment, since females showed weight gain during the second week of the study. No specific gross pathological changes were found at macroscopic post-mortem examination of the animals, except for acute injection of blood vessels in the abdominal region due to euthanasia injection. No erythema and edema were observed during the study period. During Days 6 to 8 of the observation period, eschar formation was noted in 1 of 5 males and 1 of 5 females, but was fully reversible until the end of the study. Based on these results, the dermal LD50 value for male and female rats was greater than 2000 mg/kg bw.
Inhalation
This information is not available.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for selection of acute toxicity – inhalation endpoint
Study not required according to Annex VIII of Regulation (EC) No. 1907/2006.
Justification for selection of acute toxicity – dermal endpoint
There is only one study available.
Justification for classification or non-classification
Based on the available data on acute toxicity, the test substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.
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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