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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-553-6 | CAS number: 2461-15-6
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Sub-chronic toxicity study (90-day) in rats and pre-natal test did not show adverse effects on reproductive organs or tissues, so it is not necessary to perform two-generation reproductive toxicity study.
A prenatal developmental toxicity test (similar to OECD test guideline 414) has been conducted on the surrogate substance oxirane, 2-((C12-14-alkyloxy)methyl)derivs (WIL Research Laboratories, Inc., 1997). This test was designed to provide information on the possible effects of test substance on reproduction and/or development by dermal application in the rats at concentrations of 0, 10, 50, 100 and 200 mg/kg bw/day).
All maternal animals survived to the scheduled necropsy on gestation day 20. The only treatment-related clinical sign observed was vocalization at the time of dosing in the 50, 100 and 200 mg/kg bw/day groups between gestation days 7 and 15.
Dermal irritation at the application site was observed in the 50, 100 and 200 mg/kg bw/day groups. Erythema, edema and desquamation occurred in all animals in these groups (with the exception of no edema for one 50 mg/kg bw/day group animal). The severity and/or time of onset for these findings were dose-related. More severe signs of dermal irritation were noted only at dose levels of 100 and 200 mg/kg bw/day. These included fissuring, eschar formation and atonia in two to five 100 mg/kg bw/day group animals and in all 200 mg/kg bw/day group animals. The severity of erythema and edema and the frequency of fissuring, eschar formation and atonia tended to decrease during the post-treatment period. No test article-related dermal irritation was noted at the application site in the 1 and 10 mg/kg bw/day groups. Findings at the application site were limited to scabbing in two and six animals in the 100 and 200 mg/kg bw/day groups, respectively, and thickening in two of these high dose group animals.
Parameters evaluated included post implantation loss, mean fetal body weight, viable litter size, fetal sex ratios and the mean numbers of corpora, lutea and implantation sites. One control group fetus had macroglossia. No other external malformations and no external developmental variations were observed in fetuses in this study.
In conclusion, localized dermal irritation was observed in a dose-related manner at dose levels of 50, 100 and 200 mg/kg bw/day. No systemic maternal toxicity or developmental toxicity was apparent at any dose level. Based on the results of this study, the no-effect level for dermal irritation was considered to be 10 mg/kg bw/day and the no-observed adverse effect level for maternal toxicity and developmental toxicity was considered to be 200 mg/kg bw/day.
As justified, this information can be read-across to 2-ethylhexyl glycidyl ether, considering the similarities and similar properties of the two substances.
Justification for selection of Effect on fertility via oral route:
Since the most likely route of exposure is considered to be via dermal route (oral is not a realistic workplace scenario and vapour pressure of the substance is low), the test via oral exposure can be waived and the results form a study by dermal exposure are acceptable.
Effects on developmental toxicity
Description of key information
The only treatment-related clinical sign observed was vocalization at the time of dosing in the 50, 100 and 200 mg/kg bw/day groups. No external fetal malformations were observed in the treated groups, and no external developmental variations were noted in fetuses in this study. Hence, no developmental toxicity was seen with the surrogate substance to 2-ethylhexyl glycidyl ether.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
A potential maternal toxicity and developmental toxicity of test substance was investigated by dermal route of exposure. The test article in acetone was administered as a single daily application to six groups of eight bred Crl:CD@(SD)BR rats, from gestation days 6 through 15. The test article was applied to the clipped intact dorsal skin (10% area) of each rat. The application sites were not occluded. Dosage levels were 1, 10, 50, 100 and 200 mg/kg bw/day administered at a dose volume of 1 mL/kg. A concurrent control group, composed of eight bred females, received the vehicle, acetone, on a comparable regimen at 1 mL/kg.
On day 20 of gestation, all females were euthanized and scheduled laparohysterectomies were performed. The uteri and ovaries were examined and the numbers of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Mean gravid uterine weights and net body weight changes were calculated for each group. Fetuses were weighed, sexed and examined for external malformations and developmental variations.
All maternal animals survived to the scheduled necropsy on gestation day 20; no test article-related internal findings were observed. The only treatment-related clinical sign observed was vocalization at the time of dosing in the 50, 100 and 200 mg/kg bw/day groups. Body weight gain and food consumption in the treated groups were unaffected by test article administration. Intrauterine growth and survival were also unaffected at all dose levels. No external fetal malformations were observed in the treated groups, and no external developmental variations were noted in fetuses in this study.
Hence, no developmental toxicity was observed by dermal application of oxirane, 2-((C12-14-alkyloxy)methyl)derivs (EC 271-846-8, C12-14GE) and as justified this information can be used for read-across to the target substance [[(2-ethylhexyl)oxy]methyl]oxirane.
Justification for classification or non-classification
Based on the available data, the substance [[(2-ethylhexyl)oxy]methyl]oxirane does not require classification for reproductive toxicity according to CLP (Regulation EC No.1272/2008).
Additional information
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.