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EC number: 202-114-8 | CAS number: 91-99-6
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Toxicokinetic assessment of the substance based on the available data
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- Not applicable
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: since this is a theoretical assessment, the Klimisch value cannot be 1.
- Objective of study:
- other: Toxicokinetic assessment of the substance based on the available data
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on information requirements and chemical safety assessment. Chapter R.7c: Endpoint specific guidance. European Chemical Agency, Version 6.0
- Version / remarks:
- November 2016
- Deviations:
- no
- GLP compliance:
- no
- Type:
- absorption
- Results:
- The absorption factors for risk assessment purposes are derived to be 50% (oral), 100% (inhalation) and 100% (dermal).
- Conclusions:
- A toxicokinetic assessment was performed based on the available data of Ethanol, 2,2’-[(3-methylphenyl)imino]bis-. Based on the physical/chemical properties and the toxicity data of the substance, the following absorption factors are derived for risk assessment purposes: 50% (oral), 100% (inhalation) and 100% (dermal). The bioaccumulation potential is expected to be low.
Reference
Toxicokinetic assessment
After exposure, a substance can enter the body via the gastrointestinal tract, the lungs, and the skin. Since different parameters are relevant for absorption via the different routes of exposure, the uptake via these three routes will be addressed individually.
After oral administration, in general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract. Although the water solubility of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is moderate with 9.33 g/L at 20°C, the substance will dissolve to some extent into the gastrointestinal fluids and become available for uptake. Based on its molecular weight (approx. 195), uptake via passive diffusion (passage of small water-soluble molecules through aqueous pores or carriage across membranes with the bulk passage of water) is possible. Ethanol, 2,2’-[(3-methylphenyl)imino]bis- has a moderate partition coefficient (log Pow = 1.9), which implies that this substance will dissolve in lipids and can thus cross epithelia by passive diffusion. The substance has two ionisable groups, the hydroxyl groups. No information is available on its dissociation constant, so at this point it cannot be determined if the substance is present in an ionized form along the gastro-intestinal tract. Presence in ionized form could potentially hamper uptake. For risk assessment purposes oral absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is set at 50%, based on its water solubility, its low molecular weight and its moderate log Pow and presence of ionisable groups. The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor.
Once absorbed, distribution of the substance throughout the body is expected to some extent based on its limited water solubility and moderate molecular weight. Absorbed Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is expected to be excreted via urine. Based on its moderate partition coefficient (log Pow = 1.9), it is unlikely that Ethanol, 2,2’-[(3-methylphenyl)imino]bis- will accumulate significantly in adipose tissue.
Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is expected to have a very low vapour pressure (calculated as 2.23E-04 Pa at 25°C), which indicates that exposure via air can be considered to be very limited. This is further supported by the fact that Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is a paste (at room temperature), so no potentially inhalable particles of the substance are present that need to be considered. If however, theoretically, particles reach the tracheobronchial region, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is likely to dissolve in the mucus lining of the respiratory tract and to get absorbed. Although its ability to dissolve in water is limited, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- can dissolve in lipids and is therefore able to cross biological membranes. Furthermore, the substance has irritating properties, therefore interference with the epithelium lining of the respiratory tract can be expected. Such interference is expected to significantly enhance uptake of a substance, therefore it is concluded that for risk assessment purposes as worst case the inhalation absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- should be set at 100%.
As Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is a solid, uptake through the skin is unlikely to occur unless it is dissolved in a body fluid (sweat). The water solubility of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is moderate, and considered sufficient to partition from the stratum corneum into the epidermis. Its ability to dissolve in lipids will furthermore favour easy crossing of epidermal barriers. Its moderate molecular size is expected to facilitate uptake through dermal epithelium. According to the criteria given in the REACH Guidance, 10% dermal absorption will be considered in case MW >500 and log Pow <-1 or >4, otherwise 100% dermal absorption should be used. As the physical/chemical properties of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- do not meet the criteria for limited dermal absorption (MW 195.26; log Pow = 1.9), for risk assessment purposes dermal absorption should be set at 100%. This is supported by the fact that the substance has skin irritating properties, thus the substance is expected to interfere with dermal epithelia. After the skin surface is damaged, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- will be absorbed easily due to its low molecular weight and moderate water solubility. Based on the above data, for risk assessment purposes the dermal absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is set at 100%.
Description of key information
A toxicokinetic assessment was performed based on the available data of Ethanol, 2,2’-[(3-methylphenyl)imino]bis-. Based on the physical/chemical properties and the toxicity data of the substance, the following absorption factors are derived for risk assessment purposes: 50% (oral), 100% (inhalation) and 100% (dermal). The bioaccumulation potential is expected to be low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 100
- Absorption rate - inhalation (%):
- 100
Additional information
After exposure, a substance can enter the body via the gastrointestinal tract, the lungs, and the skin. Since different parameters are relevant for absorption via the different routes of exposure, the uptake via these three routes will be addressed individually.
After oral administration, in general, a compound needs to be dissolved before it can be taken up from the gastrointestinal tract. Although the water solubility of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is moderate with 9.33 g/L at 20°C, the substance will dissolve to some extent into the gastrointestinal fluids and become available for uptake. Based on its molecular weight (approx. 195), uptake via passive diffusion (passage of small water-soluble molecules through aqueous pores or carriage across membranes with the bulk passage of water) is possible. Ethanol, 2,2’-[(3-methylphenyl)imino]bis- has a moderate partition coefficient (log Pow = 1.9), which implies that this substance will dissolve in lipids and can thus cross epithelia by passive diffusion. The substance has two ionisable groups, the hydroxyl groups. No information is available on its dissociation constant, so at this point it cannot be determined if the substance is present in an ionized form along the gastro-intestinal tract. Presence in ionized form could potentially hamper uptake.For risk assessment purposes oral absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is set at 50%, based on its water solubility, its low molecular weight and its moderate log Pow and presence of ionisable groups. The oral toxicity data do not provide reason to deviate from the proposed oral absorption factor.
Once absorbed, distribution of the substance throughout the body is expected to some extent based on its limited water solubility and moderate molecular weight. Absorbed Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is expected to be excreted via urine. Based on its moderate partition coefficient (log Pow = 1.9), it is unlikely that Ethanol, 2,2’-[(3-methylphenyl)imino]bis- will accumulate significantly in adipose tissue.
Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is expected to have a very low vapour pressure (calculated as 2.23E-04 Pa at 25°C), which indicates that exposure via air can be considered to be very limited. This is further supported by the fact that Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is a paste (at room temperature), so no potentially inhalable particles of the substance are present that need to be considered. If however, theoretically, particles reach the tracheobronchial region, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is likely to dissolve in the mucus lining of the respiratory tract and to get absorbed. Although its ability to dissolve in water is limited, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- can dissolve in lipids and is therefore able to cross biological membranes. Furthermore, the substance has irritating properties, therefore interference with the epithelium lining of the respiratory tract can be expected. Such interference is expected to significantly enhance uptake of a substance, therefore it is concluded that for risk assessment purposes as worst case the inhalation absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- should be set at 100%.
As Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is a solid, uptake through the skin is unlikely to occur unless it is dissolved in a body fluid (sweat). The water solubility of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is moderate, and considered sufficient to partition from the stratum corneum into the epidermis. Its ability to dissolve in lipids will furthermore favour easy crossing of epidermal barriers. Its moderate molecular size is expected to facilitate uptake through dermal epithelium. According to the criteria given in the REACH Guidance, 10% dermal absorption will be considered in case MW >500 and log Pow <-1 or >4, otherwise 100% dermal absorption should be used. As the physical/chemical properties of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- do not meet the criteria for limited dermal absorption (MW 195.26; log Pow = 1.9), for risk assessment purposes dermal absorption should be set at 100%. This is supported by the fact that the substance has skin irritating properties, thus the substance is expected to interfere with dermal epithelia. After the skin surface is damaged, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- will be absorbed easily due to its low molecular weight and moderate water solubility. Based on the above data, for risk assessment purposes the dermal absorption of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is set at 100%.
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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