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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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: toxicokinetic assessment based on all available information
- Adequacy of study:
- key study
- Study period:
- February-March 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: expert assessment of toxicokinetic properties based on all available information
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The toxicokinetic assessment of the test item was performed based on all available information, including structural and physico-chemical properties of the substance and the results of available toxicological studies.
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: not applicable, no animal study performed
- Type:
- absorption
- Results:
- The derived absorption values are 100% for oral and respiratory absorption and 50% for dermal absoprtion.
- Type:
- distribution
- Results:
- Distribution through the body is expected; some degree of accumulation in adipose tissue cannot be excluded.
- Type:
- metabolism
- Results:
- Glucuronidation at the terminal hydroxyl groups is possible.
- Type:
- excretion
- Results:
- Glucuronidated metabolites may be eliminated with urine; biliary and fecal excretion is also possible.
- Details on absorption:
- Based on signs of systemic toxicity in the available 28-day study with developmental/reproductive toxicity screening, the substance is absorbed by oral route. The default 100% oral absorption is assumed for risk assessment purposes.
The test item is not volatile (vapour pressure < 0.0015 Pa), and based on the aggregation state of the substance (highly viscous liquid) it is not likely that the substance can reach the nasopharyngeal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour. However, the default value of 100% is assumed for respiratory absorption for risk assessment puprposes. If a liquid reaches the tracheobronchial region, it generally would readily diffuse/dissolve into the mucus lining of the respiratory tract. For highly apolar constituents of the test item absorption may be limited due to their low water solubility and high Log Pow; however, more water-soluble constituents may be readily absorbed. Furthermore, as the substance is a surface active compound, its absorption may be enhanced due to micellar solubilisation.
the test item is a liquid which can potentially be taken up across the skin. According to the criteria given in the REACH Guidance, a default value of 100% dermal absorption should be used unless MW >500 and log Pow <-1 or >4, in which case a value of 10% skin absorption should be chosen.1 While the weighted-average molecular weight of the main identified constituents of the test item is above 500 g/mol (i.e. 624 g/mol), the log Pow of its constituents varies significantly (from < 0.3 to 7.2). It thus needs to be considered that at least part of the test item may be capable of penetrating the skin. Furthermore, the substance is surface-active, which can enhance the potential dermal uptake. However, the main fraction of the substance is constituted by substances with high molecular weight (72% of the total mass percentage constituted by substances with molecular weight in a range of 394-952 g/mol, 21% by substances with molecular weight > 1000 g/mol). Based on this, the main fraction of the compound may be too big to penetrate the skin. Therefore as a worst-case the value of 50% is assumed for dermal absorption - Details on distribution in tissues:
- Based on observed effects in the available 28-day toxicity study, upon uptake via gastrointestinal tract the substance is transported to liver where it is probably (partially) metabolized. Based on developmental effects observed in the same study, at least a part of the substance and/or its metabolites can also be distributed to other organs and tissues by systemic circulation. Based on high molecular weight and high log Pow of some components, some degree of accumulation in adipose tissue cannot be excluded.
- Details on excretion:
- Biliary and fecal excretion of some constituents may be expected to occur based on the molecular weight and high log Pow of the substance. Based on the the available toxicity results, it is also feasible to assume that at least some degree of metabolism of the substance will occur in the liver, and that the water-soluble metabolites, e.g. glucuronides and carboxylates, will be eliminated via urine.
- Metabolites identified:
- no
- Details on metabolites:
- No details on metabolites are available. Based on data from analogous substance BADGE the hydrolysis of the phenyl ether moiety will not occur. It is possible that the substance may be glucuronidated at least to some extent at the terminal hydroxyl moieties, or that one of the diol groups can be oxidized to yield the α-hydroxycarboxylic acid and, after decarboxylation, carboxylic acid.
- Conclusions:
- Based on the results of the toxicokinetic assessment, absorption values of 100%, 100% and 50% are derived for oral, respiratory and dermal absorption of the substance, respectively. Upon uptake via gastrointestinal tract the substance is probably distributed to the liver, where it can be partially oxidized to yield the α-hydroxycarboxylic acid and, after decarboxylation, carboxylic acid, or glucuronidated at the terminal hydroxyl groups. High molecular weight constituents are probably undergoing faecal and biliary excretion, while water-soluble metabolites can be excreted in urine. Based on adverse effects in the 28-day study, the substance and/or its water-soluble metabolites can be distributed through the body by systemic circulation. Some degree of accumulation in adipose tissue cannot be excluded for highly apolar constituents.
- Executive summary:
Toxicokinetic assessment for the test item was performed based on the analysis of all available information, i.e. structural and physico-chemical properties and the results of available toxicological studies. Based on signs of systemic toxicity in the available 28-day study with developmental/reproductive toxicity screening, the substance is absorbed by oral route. The default 100% oral absorption is assumed for risk assessment purposes. The substance is not volatile (vapour pressure < 1.5 × 10 -3 Pa), and based on the aggregation state of the substance (highly viscous liquid) it is not likely that the substance can reach the nasopharyngeal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour. However, the default value of 100% is assumed for respiratory absorption for risk assessment puprposes. As the major fraction of the substance consists of the substances with high molecular weight (21% with MW > 1000 g/mol, 72% with MW in the range of 392 -952 g/mol) and high log Pow (range from < 0.3-7.2), 50% dermal absorption is considered as a worst-case value. Based on observed effects in the available 28-day toxicity study, upon uptake via gastrointestinal tract the substance is transported to liver where it is probably (partially) metabolized. As the bis-diol structures have been shown to be stable molecules, the hydrolysis of the phenyl ether moiety will not occur. It is possible that the substance may be glucuronidated at least to some extent at the terminal hydroxyl moieties, or that one of the diol groups can be oxidized to yield the α-hydroxycarboxylic acid and, after decarboxylation, carboxylic acid. Based on developmental effects observed in the same study, water-soluble constituents and/or metabolites can be distributed to other organs and tissues by systemic circulation. Based on high molecular weight and high log Pow of some components, some degree of accumulation in adipose tissue cannot be excluded. Biliary and fecal excretion of some constituents may be expected to occur based on the molecular weight and high log Pow of the substance, while water-soluble metabolites, e.g. glucuronides and carboxylates, will be eliminated via urine.
Reference
Description of key information
Based on the results of the toxicokinetic assessment, absorption values of 100%, 100% and 50% are derived for oral, respiratory and dermal absorption of Uradil DD80, respectively. Upon uptake via gastrointestinal tract the substance is is transported to liver where it is probably (partially) metabolized to yield the α-hydroxycarboxylic acid and, after decarboxylation, carboxylic acid, or glucuronidated at the terminal hydroxyl groups. High molecular weight constituents are probably undergoing faecal and biliary excretion, while water-soluble metabolites can be excreted in urine. Based on adverse effects in the 28-day study, the substance and/or its water-soluble metabolites can be distributed through the body by systemic circulation. Some degree of accumulation in adipose tissue cannot be excluded for highly apolar constituents.
Key value for chemical safety assessment
- Bioaccumulation potential:
- high bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
Toxicokinetic assessment for Uradil DD80 was performed based on the analysis of all available information, i.e. structural and physico-chemical properties and the results of available toxicological studies. Based on signs of systemic toxicity in the available 28-day study with developmental/reproductive toxicity screening, the substance is absorbed by oral route. The default 100% oral absorption is assumed for risk assessment purposes. Uradil DD80 is not volatile (vapour pressure < 1.5 × 10-3Pa), and based on the aggregation state of the substance (highly viscous liquid) it is not likely that the substance can reach the nasopharyngeal region or subsequently the tracheo/bronchial/pulmonary region via inhalation of vapour. However, the default value of 100% is assumed for respiratory absorption for risk assessment purposes. As the major fraction of the substance consists of the substances with high molecular weight (21% with MW > 1000 g/mol, 72% with MW in the range of 392 -952 g/mol) and high log Pow (range from < 0.3-7.2), 50% dermal absorption is considered as a worst-case value. Based on observed effects in the available 28-day toxicity study, upon uptake via gastrointestinal tract the substance is transported to liver where it is probably (partially) metabolized. As the bis-diol structures have been shown to be stable molecules, the hydrolysis of the phenyl ether moiety will not occur. It is possible that the substance may be glucuronidated at least to some extent at the terminal hydroxyl moieties, or that one of the diol groups can be oxidized to yield the α-hydroxycarboxylic acid and, after decarboxylation, carboxylic acid. Based on developmental effects observed in the same study, water-soluble constituents and/or metabolites can be distributed to other organs and tissues by systemic circulation. Based on high molecular weight and high log Pow of some components, some degree of accumulation in adipose tissue cannot be excluded. Biliary and fecal excretion of some constituents may be expected to occur based on the molecular weight and high log Pow of the substance, while water-soluble metabolites, e.g. glucuronides and carboxylates, will be eliminated via urine.
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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