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EC number: 618-460-1 | CAS number: 9010-89-3
- 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
Description of key information
Key value for chemical safety assessment
Additional information
No repeated dose toxicity data are available for Hexanedioic acid, polymer with 2,2'-oxybis[ethanol]. As extensively discussed in
section 7.1 of the IUCLID, read across to the hydrolysis products adipic acid and diethylene glycol was conducted in accordance
with section 1.5 of REACH Annex XI.
Diethylene glycol (DEG) was tested in a 225-day oral feeding study (Gaunt et al., 1975). Male and female rats were given concentrations of 0.85, 0.17, 0.4 and 2.0% (= 64, 128, 300, and 1500 mg/kg bw/day). The elevated levels of oxalic acid in urine in this study were considered to be a biomarker and do not indicate toxicity. Mild defects of renal function at 0.4% DEG were considered to define the NOAEL as 128 mg/kg bw/day.
Another oral repeated-dose study (BASF 1988, acc. to OECD guideline 407) is available for DEG (http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d913d37-b787-0c08-e044-00144f67d249/DISS-9d913d37-b787-0c08-e044-00144f67d249_DISS-9d913d37-b787-0c08-e044-00144f67d249.html). At the highest dose (40 000 mg/kg diet), a significant concentration and amount of oxalic acid was found in the urea of both sexes, and oxalic acid stones in males after 28 days. However, these effects were reversible within 30 days, as demonstrated by means of arecovery group. The NOAEL was 10 000 mg/kg diet corresponding to 936 mg/kg bw/day.
A number of oral repeated dose studies are available for adipic acid (ADS) (http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ebef55e-5c54-185f-e044-00144f67d031/DISS-9ebef55e-5c54-185f-e044-00144f67d031_DISS-9ebef55e-5c54-185f-e044-00144f67d031.html).
The most reliable one was considered to be a chronic feed study (Horn et al., 1957), which was, however, not conducted according
to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body
weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. Evaluation of further oral repeated dose data, including human data, gave no evidence of classifiable specific target organ toxicity.
DEG accounts for the main molar fraction of Polyesterol 90212 (see below) and, of the polyesterol’s hydrolysis products DEG and ADS, showed the more critical NOAEL upon chronic oral feeding. Therefore, the DEG NOAEL of 128 mg/kg bw/day was used to estimate a NOAEL for Polyesterol 90212.
Polyesterol 90212 is composed of the following constituents(see chapter 1.2 of the IUCLID):
32 %: 2,2'-Oxybis(ethanol) (DEG);
35 %: HO((CH2CH2-O-CH2CH2-O-C(=O)-(CH2)4-C(=O)-O)n)-CH2CH2-O-CH2CH2-OH; n = 1;
32 %: HO((CH2CH2-O-CH2CH2-O-C(=O)-(CH2)4-C(=O)-O)n)-CH2CH2-O-CH2CH2-OH; n = 2;
Taking into account the characterization above, DEG in total constitutes 74.6% of the polyesterol. Conversion of the NOAEL identified for DEG (128 mg/kg based on renal effects; Gaunt et al., 1975) results in a NOAEL of 172 mg/kg for Polyesterol 90212[=(100*128)/74.6].Justification for classification or non-classification
Based on the information available for its hydrolysis products, diethylene glycol and adipic acid, classification of the test substance according to Regulation (EC) No. 1272/2008 and Directive 65/548/EEC is not warranted.
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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