Registration Dossier
Registration Dossier
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: 807-159-2 | CAS number: 69701-99-1
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun 2017 - 25 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 807-159-2
- Cas Number:
- 69701-99-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch: 09892701
- Purity: 99.9%
- Physical state/ Appearance: clear colourless liquid
- Expiry Date: 06 March 2018
- Storage Conditions: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Fasting period before study:
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum, with the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Water: ad libitum, with the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Acclimation period: at leat 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30- 70
- Air changes (per hr): at least 15
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- For the purpose of the study the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in arachis oil BP. For the purpose of the 2000 mg/kg dose level the test item was used as supplied
- Details on oral exposure:
- In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was treated at 2000 mg/kg.
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of 4 animals was treated at 2000 mg/kg.
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 1 in the 300 mg/kg dose
5 n the 2000 mg/kg dose - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days.
- Frequency of individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes . This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
- Preliminary study:
- A sighting test has been conducted at dose levels of 300 mg/kg and 2000 mg/kg.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were ataxia, hunched posture and lethargy. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg.
- Gross pathology:
- Abnormalities noted at necropsy of one animal treated at a dose level of 2000 mg/kg were ulcerated gastric mucosa, stomach adhered to the wall of the abdomen and thickened non-glandular epithelium of the stomach. No abnormalities were noted at necropsy
of the remaining animals that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD5o) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. There were no deaths.
Clinical Observations. Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were ataxia, hunched posture and lethargy. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg.
Body Weight. Animals showed expected gains in body weight except for one animal treated at a dose level of 2000 mg/kg which showed body weight loss during the first week with expected gain in body weight during the second week.
Necropsy. Abnormalities noted at necropsy of one animal treated at a dose level of
2000 mg/kg were ulcerated gastric mucosa, stomach adhered to the wall of the abdomen and thickened non-glandular epithelium of the stomach. No abnormalities were noted at necropsy of the remaining animals that were killed at the end of the study.
Conclusion
The acute oral median lethal dose (LDso) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Category 5).
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.
