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Diss Factsheets
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EC number: 263-171-2 | CAS number: 61791-39-7
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8.1).
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, May 2008)
- GLP compliance:
- no
- Remarks:
- (Not relevant for assessment)
- Conclusions:
- The available information suggests that absorption of the test substance from the gastrointestinal tract may take place, primarily as a consequence of the high log octanol/ water coefficient of the test item. Some absorption may also take place via the skin. Once absorbed, the substance would result in accumulation in the adipose tissues. Biliary excretion may well be significant route for the substance. There is no evidence to suggest that the test substance may be metabolised, however no studies have been conducted to identify metabolites.
- Executive summary:
The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physicochemical properties of the substance. Once absorbed, the substance could accumulate in the adipose tissues. Biliary excretion is considered to be the significant route for the substance.
Reference
TOXICOKINETIC BEHAVIOUR
The substance is composed, as listed in the Section 1.2 of IUCLID. It is an amber coloured viscous liquid and the molecular weight is 86.35-109.78 g/mol. The low vapour pressure value (5.1 x 10-4 Pa at 25°C) and predicted negative explosive and oxidising properties shows that the substance is non volatile therefore inhalation is not a significant route of exposure. The substance has a high log octanol/water partition coefficient value (Log10 Pow 5.4) and low water solubility 2.0 E-155 – 1.7 E-4). The available acute oral and dermal studies as well as the repeated dose reproductive screening study showed evidence for potential absorption; however it did not show any evidence of metabolism or excretion.
The test item was non-mutagenic in bacteria, non-clastogenic in mammalian cells in vitro and non-mutagenic in mammalian (CHO) cells in vitro in either the absence or presence of an auxiliary metabolising system.
Absorption
Results of the acute oral study and repeated dose reproductive screening study in rats showed evidence to support the potential gastric absorption of the test item. This is supported by the lipophilic nature of the substance (log10 Pow of 5.4). This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. The small molecular size of the substance may allow absorption through passive diffusion.
Absorption may also take place via the skin, the lipophilicity of the test item may allow penetration of the dermal membrane and absorption may also take place via the skin due to small molecular size. The substance is considered to be corrosive and there is evidence of dermal irritation however it is not considered to be a skin sensitizer. Therefore damage to the skin surface may allow for increased penetration of the substance through the skin.
The low vapour pressure value (maximum 5.1 x E-04 Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.
Distribution
Once absorbed, the substance may potentially accumulate in the adipose tissue due to the high log octanol/water partition coefficient value (Log10 Pow 5.4).
Metabolism
The results of the reproductive screening study and teratogenicity study did not show evidence to indicate any test item influenced hepatic metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system.
Excretion
There is no evidence to indicate the route of excretion but poor water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. Any test item that is not absorbed will be excreted in the faeces.
Description of key information
Theoretical assessment based on the available information from toxicity studies and physico-chemical characteristics.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
Additional information
The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physicochemical properties of the substance.
Once absorbed, the substance could accumulate in the adipose tissues. Biliary excretion is considered to be the significant route for the substance. There is no evidence to suggest that the test substance may be metabolised, however no studies have been conducted to identify metabolites..
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.