Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 204-612-0 | CAS number: 123-25-1
- 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
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 90
- Absorption rate - dermal (%):
- 3
Additional information
According to JECFA (JECFA, 2000. Evaluation of certain food additives and contaminants. Fifty-third meeting of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series no. 896., 1–10 June 1999 and JECFA, 2002. Evaluation of certain food additives and contaminants. Fifty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, no. 909. Geneva, 5–14 June 2001), studies on the absorption, metabolism and elimination of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters with additional oxygenated functional groups show that these substances are readily hydrolysed and absorbed and are completely metabolized.
Many of these substances or their metabolites are endogenous in humans. Mono-esters (ethyl acetoacetate, ethyl 4-oxovalerate and aliphatic esters of lactic acid) and di-esters (diethyl succinate and diethyl malonate) are expected to undergo hydrolysis in humans to yield their corresponding alcohol and acid components (i.e. β- or γ-keto or α-hydroxy acids; or diacids), which would be further metabolised and excreted through the common pathways of detoxication of aliphatic alcohols and carboxylic acids.
JECFA stated also that the presence of a second oxygenated functional group has little if any effect on hydrolysis of these esters.
Hydrolysis is catalysed by classes of enzymes recognised as carboxylesterases or esterases (Heymann E, 1980. Carboxylesterases and amidases. In: Jakoby WB (Ed.). Enzymatic basis of detoxication. 2nd Ed. Academic Press,, pp. 291–323), the most important of which are the β-esterases (Heymann, 1980; Anders, 1989).
Acetyl esters are the preferred substrates of C-esterases (Heymann, 1980). Mammalian carboxylesterases represent a multigene family and play an important role in the hydrolytic biotransformation of a vast number of structurally diverse drugs (Satoh and Hosokawa 1998). Carboxylesterase activity also plays a significant role in detoxification processes in fish (Di Giulio, R. T.; Hinton, D. E. (2008): The toxicology of fishes.: CRC Press; Tocher D R, 2003. Metabolism and Functions of Lipids and Fatty Acids in Teleost Fish. In: Reviews in Fisheries Science, Vol.11, No. 2, pp. 107–184) as well as in birds (Beasley V, 1999. Absorption, Distribution, Metabolism, and Elimination: Differences Among Species. In: Veterinary Toxicology). The most probable metabolic reactions of the hydrolysis products are: oxidation of alcohols to aldehydes and acids; conjugations of alcohols and acids to glucuronides and sulphates; β-oxidation of carboxylic acids; ω-oxidation of carboxylic acids.
β-Keto acids and derivatives like acetoacetic acid undergo decarboxylation. Along with α-keto and α-hydroxyacids (lactic acid), they yield breakdown products, which are incorporated into normal biochemical pathways. The γ-keto-acids and related substances (4-oxovaleric acid) may undergo complete or partial β-oxidation to yield metabolites that are eliminated in the urine. Simple aliphatic di-carboxylic acids (succinic acid and fumaric acid) and their precursors (2-oxopropanal) are metabolised in the fatty acid β-oxidation pathway or tricarboxylic acid cycle (EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC), 2009. Scientific Opinion on Flavouring Group Evaluation 10, Revision 1 (FGE.10Rev1). Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical group 9,13 and 30. EFSA Journal, ON-934, 1–114).
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