Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 271-517-9 | CAS number: 68583-52-8
- 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
There is no repeated dose toxicity information available for the test substance. The structurally related material, ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-ethylhexanoate)(CAS No. 94 -28 -2) was adiminstered by gavage to male and female Wistar rats for at least 28 days at dose levels in the diet 1500, 5000 and 15000 ppm. These treatments revealed parental toxicity at 15000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 5000 ppm was derived. When corrected for mean test article intakethe NOAEL of 5000 ppm corresponds to 314-576 mg/kg body weight/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The subject material is a member of a US HPV Glycol Esters category.
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see Remark:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 314 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Based on a weight of evidence analysis, the quality of the database is considered sufficient.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance is a member of a category of aliphatic esters submitted by The American Chemistry Council's (ACC) Aliphatic Esters Panel (Panel) under the High Production Volume (HPV) Chemical Challenge Program (ACC, 2003). Information from a Screening Information Data Set (SIDS) developed in that program serves as supplementary or weight-of-evidence in the current dossier. Category ester compounds with similar structures and functionalities were of low toxicity following repeated oral dosing. The structurally related material, heptanoic acid, oxybis(2,1-ethanediyloxy-2,1-ethanediyl) ester (CAS 70729 -68 -9) was adiminstered by gavage to male and female Wistar rats for 28 days at a limit dose of 1000 mg/kg bw. This was followed by a 14 -day recovery period. There were no adverse, treatment related effects identified. The NOAEL was assigned as 1000 mg/kg bw/day. The test material 2,2'-ethylenedioxydiethyl bis(2 -ethylhexanoate) (CAS 94 -28 -0) showed no adverse effects with respect to food consumption, weight gain, behavior, hematology, clinical serum chemistry, liver or kidney weight, or gross or microscopic appearance of organs following dietary exposure for 12 days to 0.1% or 1.0% (approx. 80 or 800 mg/kg bw/day. The test material heptanoic acid, ester with 2,2,4 -trimethyl-1,3 -pentanediol (CAS 71839 -38 -8) was tested in rats in an OECD 407 guideline study. The no-observed-adverse-effect-level was assigned as 180 mg/kg bw.day based on the formation of the male-rat specific hyaline droplet formation. Doses of CAS 71839 -38 -8 up to 1000 mg/kg bw/day were otherwise well tolerated in animals with no mortality or clinical signs of toxiciyt. After 28 days of repeated dose exposure to up to 1000 mg/kg/day, there was no indication that the test material adversely affected the reproductive organs in male and female rats. No histopathological or gross abnormalities were reported for testes, epididymides and ovaries
Justification for classification or non-classification
Based on the results of repeated-dose oral toxicity testing in rats of structurally similar substances, the test substance would not be classified for repeated-dose toxicity according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.