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EC number: 404-800-4 | CAS number: 118832-72-7 IRGANOX L 118
- 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)
Description of key information
Key value for chemical safety assessment
Additional information
Assessment of the Toxicokinetic Behavior
The test substance is a yellowish viscous liquid with a density of 979.3 kg/m³ at 20°C, a boiling point of 396°C at 1013 hPa and a molecular weight of 492 g/mol. The test article has a vapor pressure of 0.000036 Pa at 20°C and is characterized by very low water solubility (< 0.08 mg/l at 20°C) and good solubility in fat (>100 g/100 g of fat). The log Pow was determined to be 11.6. No studies are available investigating the toxicokinetic properties of the test substance. The toxicokinetic behavior is therefore assessed based on physic-chemical properties and on available toxicity studies.
Absorption
The molecular weight of the test substance is below 500 g/mol and therefore absorption is favored. The lipophilic character and the high log Pow do not suggest absorption by passive diffusion, however highly lipophilic compounds can be taken up by micellular solubilization, particularly those that are poorly soluble in water, which is the case for test substance. It is therefore concluded that the test substance might be absorbed in the gastro-intestinal tract after oral administration and distributed to target organs by the systemic blood circulation thereafter. This is confirmed by the appearance of toxicity up to lethal effects after oral exposure. In subacute toxicity studies in rodents, liver was identified as target organ. The liver effects (increased organ weight, centrilobular enlargement of hepatocytes and induction of cytochrome P450 and lauric acid 11- and 12-hydroxylase activity) characterized the test article as a phenobarbitone-like inducer and peroxisome proliferator. This is supported by ultrastructural investigations demonstrating an increase in number and size of peroxisomes and a moderate proliferation of smooth endoplasmic reticulum membranes. The effects in the liver are considered to be an adaptive response of the test article acting as an inducer of hepatic drug metabolizing enzymes.
Absorption via skin is expected to be very low, since molecular weight and its high log Pow impede skin permeability. This is supported by the absence of systemic toxicity in the acute dermal study. Inhalative exposure to the test substance is of no relevance due to its low vapor pressure.
Metabolism
Metabolism of the test article by the action of esterases and carboxy esterases in the intestinal cells, plasma and hepatocytes will probably affect the ester moiety and lead to the formation of the free acid and 1-tridecanol. The latter is expected to undergo ω-oxidation in the microsomes and consequently to be degraded via acetyl-CoA and the Krebs cycle. A significantly minor amount of ester cleavage is already possible under acidic conditions of the stomach. However, acidic ester hydrolysis is assumed to occur rather slowly. Contrarily, esterases act quickly and efficiently. In consequence, the amount of free acid and long-chain alcohol generated in the stomach significantly depends on the rate of gastro-intestinal passage. Metabolism at the phenolic hydroxyl-group is unlikely to occur based on steric hindrance by the tertiary butyl groups in ortho position.
Excretion
As the symptoms in the subacute toxicity studies were mostly reversible within the recovery period of two weeks, the test substance is assumed to be eliminated efficiently. This is supported by the results of ADE studies in rats and miniature pigs with the structure-related, C14-radiolabeled S-(3,5-di-tert-butyl-4-hydroxybenzyl)-thioglycolic-acid-2-ethyl-hexylester. A C14-radiolabel at the phenolic moiety facilitates the recovery of the parent compounds as well as of the toxicological most critical moiety of the substance - the free acid - after metabolic ester cleavage. It can be assumed that the long-chain alcohol 1-tridecanol is of low toxicological concern. An effective metabolic degradation and renal elimination associated with a neglectable accumulating potential is likely. C14-labeled S-(3,5-di-tert-butyl-4-hydroxybenzyl)-thioglycolic-acid-2-ethyl-hexylester is rapidly absorbed via the gastrointestinal tract, reaching maximum blood concentrations at 2-4 hours post administration. Radioactivity, reflecting the parental compound and its metabolically formed free acid, decreased markedly in blood within 48 hours after administration. Fecal excretion was identified as the main route of elimination. Within a 168 hours period, C14-labeled S-(3,5-di-tert-butyl-4-hydroxybenzyl)-thioglycolic-acid-2-ethyl-hexylester was eliminated entirely.
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