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EC number: 943-366-5 | 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)
Description of key information
The constituents of the target substance hydrolyses rapidly when in contact with water or moisture finally to acetic acid and adipic acid.
Absorption: Expected to occur via oral route and via lungs.
Distribution: The hydrolysed substances are expected to distribute throughout the major tissues.
Metabolism: Acetic acid and adipic acid are oxidised to the normally occurring metabolites of lipid and protein metabolic pathways.
Excretion: The substances are partially excreted in the urine or via the lungs.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
No specific studies have been conducted for the target substance. The substance is composed of acetic anhydride (5-10 wt. %), adipic acid,di-anhydride with bis(acetic acid) (50-62 wt. %) and acetic acid (30-35 wt. %). The main and the most hazardous component of this substance is acetic anhydride which has well-known corrosive and irritating effects on the eyes, skin and respiratory tract.
Since acetic anhydride is unstable in water and decomposes immediately (half-life about 4 minutes) in contact with water to acetic acid/acetate, systemic toxicity is unlikely. Thus, the toxicokinetic behaviour of acetic acid/acetate instead of acetic anhydride is focused in CSA. Adipic anhydrides hydrolyse also rapidly when in contact with water to adipic acid and acetic acid. Thus, the toxicokinetic behaviour of adipic acid is discussed below.
Absorption
Acetic anhydride is highly irritating and readily hydrolyses to acetic acid. Therefore, local toxicity at site of contact is observed, but not systemic toxicity.
Acetic acid is absorbed from the gastrointestinal tract and through the lungs. The acetate ion (the anion of acetic acid) is a normally-occurring metabolite in catabolism or in anabolic synthesis, e.g. in the formation of glycogen, cholesterol synthesis, degradation of fatty acids, and acetylation of amines.
Acetic acid is absorbed from the stomach of rats; the percentage absorbed decreases with increasing dose Hertling D.C., et al.(1956). The data shows that acetic acid is totally absorbed (100%) when 20 mg is gavaged, 80% when 50 mg is gavaged, 75% when 80 mg is gavaged and 30 % when 420 mg is gavaged.
In animals and humans it was shown that adipic acid is absorbed after oral administration (Rusoff, II et al., 1960).
Distribution
It is estimated that the level of the acetate ion in humans is about 50–60 µmol/l (3.0–3.6 mg/l) in plasma and 116 µmol/l (7 mg/l) in cerebrospinal fluid. Daily turnover of the acetate ion in humans is estimated to be about 7.5 µmol/kg/min representing some 45 g/day (HSDB, 2016).
At plasma pH (7.4) only about 0.23% of the acetate was unionised and able to permeate across a lipid barrier. Over a 60 min period during which plasma concentrations of acetate were maintained at 22 umol/mL, the maximum concentration in cerebral spinal fluid (CSF) was approximately 20x lower than in plasma (HSDB, 2016).
Metabolism / Excretion
Acetic acid is readily metabolized by most tissues and may give rise to the production of ketone bodies as intermediates. Metabolism of 14(C) acetate in mice results in radioactivity associated with the protein fractions of plasma and most major tissues (Bingham, E. et al., 2001). In rats given radiolabelled acetate in diet, 50 % of the radiolabel was excreted as CO2 (Lundberg, 1988).
Acetate is rapidly eliminated. Elimination half lives were 3.0±0.5, 4.0±0.3, 4.1±0.4 and 5.0±0.5 minutes at doses of 3, 4, 5 and 6 mM/kg, respectively (Freundt, KJ. 1973)
Adipic acid or adipate are partially oxidized in the lipid metabolism pathways and excreted via the kidney or the lungs (OECD; SIDS, 2004).
As acetic acid and adipic acid are metabolized and excreted rapidly, these substances are not expected to have bioaccumulation potential.
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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