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Diss Factsheets
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EC number: 274-040-4 | CAS number: 69563-51-5
- 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:
- calculation (if not (Q)SAR)
- Adequacy of study:
- supporting study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Calculation/prediction method
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The absorption, distribution, metabolism and excretion of FAT 36034/H TE have been predicted in the absence of toxicokinetic studies.
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 12-45 - Radiolabelling:
- no
- Conclusions:
- The studies conducted for FAT 36034/H provided no evidence to indicate absorption, distribution or clearance of the test substance, however; based on supporting toxicological information performed for a similar chemical structured test substance the most likely route of excretion of FAT 36034/H following oral exposure is indicated to be via the gastro intestinal tract in the faeces.
- Executive summary:
The absorption, distribution, metabolism and excretion of FAT 36034/H have been predicted in the absence of toxicokinetic studies. For FAT 36034/H no absorption was indicated via a single oral gavage administration or from topical application to intact skin nor ocular routes of exposure, hence dermal absorption is expected to be low. However, the available data confirmed the test item can cause skin sensitisation therefore low levels of dermal absorption may occur through damaged skin. Repeated dose oral toxicity data derived from a similar chemical substance produced by the study sponsor indicated absorption of the test substance and or metabolites will take place in the gastro-intestinal track following oral gavage administration. No uptake via inhalation is anticipated on the basis that the inhalable particle size fraction was determined to be 15.0% at <100 μm indicating almost all inhaled particles will be cleared in the oral/nasal region and subsequently swallowed with the mucus. FAT 36034/H and/or its predicted metabolites have the potential for systemic distribution. Repeated dose oral toxicity data derived from a similar chemical substance produced by the study sponsor indicated FAT 36034/H and/or its predicted metabolites could potentially be distributed throughout the body, as indicated from the effects seen from the “read-across” product in which treatment related effects were identified in the spleen and bone marrow. The studies conducted for FAT 36034/H provided no evidence to indicate absorption, distribution or clearance of the test substance, however; based on supporting toxicological information performed for a similar chemical structured test substance the most likely route of excretion of FAT 36034/H following oral exposure is indicated to be via the gastro intestinal tract in the faeces.
Reference
Absorption
Neither the physico-chemical properties nor the available toxicological information provide any indication of a route of absorption. The low water solubility will not enhance absorption across the gut wall by normal diffusion therefore; there is less likelihood of significant absorption. However, a combined repeated dose oral toxicity study with reproduction/developmental toxicity screening performed for a similar chemical structured test substance produced by the study sponsor indicated test item and or metabolite bioavailability and that in all probability the gastro-intestinal tract provides the primary route of absorption; subsequently entering the circulatory systemviathe blood. The test item was shown to be a skin sensitizer therefore damage to the skin barrier may permit increased test item penetration. However, the lack of evidence of any form of irritation from the topical dermal and ocular irritation studies together with absence of any convincing evidence of systemic toxicity from the single dose oral toxicity (LD50 >2000 mg/kg) substantiate that from the data available for studies conducted with FAT 36034/H TE that this test substance has minimal toxic potential whether absorbed through the dermis or gastro-intestinal routes. Furthermore, low water solubility would not enhance absorption across the gut wall by normal diffusion therefore; there is less likelihood of significant absorption. A low octanol/water partition coefficient also suggest passage across biological membranes would be limited.
Distribution
There is minimal information available relating to the distribution of FAT 36034/H TE; however, neither the physico-chemical properties nor the available toxicological information provide any clear indication of a mechanism for distribution.
Metabolism
The test item was found to be mutagenic in bacteria albeit no information was provided to indicate whether this was in the absence or presence of metabolic activation; nevertheless, rat S9 fraction does not necessarily reflect human metabolism. Furthermore, there was no evidence to suggest that the test substance may be metabolised, although no studies have yet been conducted to identify metabolites.
Excretion
Poor water-soluble products are not favourable for urinary excretion and therefore excretion of unabsorbed test material is most likely to be via the faeces.
Description of key information
The absorption, distribution, metabolism and excretion of FAT 36034/H have been predicted in the absence of toxicokinetic studies. FAT 36034/H no absorption was indicated via a single oral gavage administration or from topical application to intact skin nor ocular routes of exposure, hence dermal absorption is expected to be low. However, the available data confirmed the test item can cause skin sensitisation therefore low levels of dermal absorption may occur through damaged skin. Repeated dose oral toxicity data derived from a similar chemical substance produced by the study sponsor indicated absorption of the test substance and or metabolites will take place in the gastro-intestinal track following oral gavage administration. FAT 36034/H no uptake via inhalation is anticipated on the basis that the inhalable particle size fraction was determined to be 15.0 % at <100 μm indicating almost all inhaled particles will be cleared in the oral/nasal region and subsequently swallowed with the mucus. FAT 36034/H and/or its predicted metabolites have the potential for systemic distribution. Repeated dose oral toxicity data derived from a similar chemical substance produced by the study sponsor indicated FAT 36034/H TE and/or its predicted metabolites could potentially be distributed throughout the body, as indicated from the effects seen from the “read-across” product in which treatment related effects were identified in the spleen and bone marrow. The studies conducted for FAT 36034/H provided no evidence to indicate absorption, distribution or clearance of the test substance, however; based on supporting toxicological information performed for a similar chemical structured test substance the most likely route of excretion of FAT 36034/H following oral exposure is indicated to be via the gastro intestinal tract in the faeces.
Key value for chemical safety assessment
Additional information
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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