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Diss Factsheets
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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
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitizing potential of Hexanedioic acid, polymer with 2,2'-oxybis[ethanol] was evaluated in a weight-of-evidence approach,
by means of QSAR (quantitative structure-activity relationship) calculation and read across to the hydrolysis products of the test
substance, adipic acid and diethylene glycol. Read across to the hydrolysis products is considered appropriate in accordance with
section 1.5 of REACH Annex XI.
The skin sensitization potential of the test substance was predicted by means of TIMES-SS, a validated quantitative structure-activity
relationship (QSAR) system. The QSAR program calculated a negative sensitization potential of the test substance.
The substance was within the total domain, structural and parametric domain of the system.Adipic acid was tested for skin sensitization in a non-guideline guinea pig maximization test (Haskell 1974). Groups of 10 guinea
pigs were given series of four sacral intradermal injections, one each week over a three-week period, which consisted of 0.1 ml of
a 1.0 % solution of adipic acid (99.99 %) in water. Following a two-week rest period, the test animals were challenged for sensitisation
by applying, and lightly rubbing in, approximately 0.05 ml of a 50 % and 25 % suspension of the test material in propylene glycol on
the shaved intact shoulder skin. A group of 10 previously unexposed animals received similar applications at the time of challenge to
provide direct comparison of the challenge reactions on the skin of similar age. The compound produced very mild to no skin irritation
to previously unexposed guinea pigs and did not cause sensitisation.
Further sensitization data for adipic acid (see REACH registration dossier 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), including a GPMT with a mixture and several human case studies also indicate that the test substance does not need to be
classified for skin sensitization according to Regulation (EU) 1272/2008 and Directive 65/548/EEC.
The skin sensitization potential of diethylene glycol was assessed in a study conducted according to EU Method B.6
(Skin Sensitization). For intradermal induction a 5% diethylene glycol (DEG) formulation in NaCl and for epidermal induction a
75% DEG formulation in water were used. A 50% DEG formulation in water was applied for challenge. No skin reactions could
be observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of a QSAR investigation, and taking into account in-vivo data from the hydrolysis products of the test substance, Hexanedioic acid, polymer with 2,2'-oxybis[ethanol] does not need to be classified for skin sensitization according to Regulation (EC) 1272/2008 and Directive 65/548/EEC.
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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