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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-560-6 | CAS number: 108-20-3
- 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
Carcinogenicity
Administrative data
Description of key information
While a GLP, oral gavage, rat carcinogenicity study similar in design to OECD test guideline 451 is available (Belpoggi 2002), due to flaws in the study methodology and data interpretation for this study, the utility of this study for providing information on the carcinogenicity of diisopropyl ether is unclear. As negative results were reported in all genotoxicity studies and the repeated dose study does not indicate that the test substance induces hyperplasia or pre-neoplastic lesions, and in accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex X, the carcinogenicity study (required in section 8.9.1.) does not need to be conducted.
Key value for chemical safety assessment
Justification for classification or non-classification
While REACH does not require a carcinogenicity study as negative results were reported in all genotoxicity studies and the repeated dose study does not indicate that the test substance induces hyperplasia or pre-neoplastic lesions, Belpoggi et al. (2002) published a study indicating DIPE is a potential carcinogen. Based on expert opinion, the Belpoggi et al. study is considered to be of limited usefulness for the purpose of identifying a potential carcinogenic effect of diisopropyl ether as it provides no convincing evidence for such an effect. As a result, the data is inconclusive for classification according to Regulation (EC) No 1272/2008, Annex I section 3.6.
Additional information
The carcinogenicity of diisopropyl ether (DIPE) was evaluated in a lifetime carcinogenicity study in rats (Belpoggi 2002). This GLP study was similar in design to OECD test guideline 451. DIPE was administered by oral gavage at 0 (olive oil vehicle), 250, or 1000 mg/kg bw/day to Sprague-Dawley rats for 78 weeks, 4 days a week (100 rats/sex/group). Animals remained untreated until spontaneous death and were then assessed for complete gross necropsy and microscopic examinations. There were no differences in mortality, body weight, food consumption, behaviour, or treatment-related non-oncological pathological changes between treatment and control groups. The study authors concluded that there was an increase in various neoplastic lesions in DIPE-treated animals. This included an increase in total malignant tumors in males and females, increased incidence of ear duct carcinomas in males and females, the onset of interstitial cell adenomas of the testis, and slight increase in malignant sarcomas of the uterus and vagina. Based on these findings, the study authors did not identify a NOAEL.
A review of the data in the publication indicates that many of the conclusions made by the authors are not consistent with the data presented in the report. A comparison of incidence values for many of these findings to those reported for controls in other studies at the same facility indicates that the incidence of tumors reported in the DIPE-treated animals were in many cases consistent with those observed in control animals in other studies. Additionally, the reliability of the ear duct findings is in question as Cruzan (2009) conducted an independent review of slides from the same facility for another study and did not agree with the classification of lesions as ear duct carcinomas. Therefore, this study is considered to be of limited usefulness for the purpose of identifying a potential carcinogenic effect of DIPE due to flaws in study methodology, data analysis, and interpretation.
Reference
Cruzan G (2009). Assessment of the cancer potential of methanol. Crit Rev Toxicol 39(4):347-363.
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.