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Diss Factsheets
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EC number: 201-555-3 | CAS number: 84-72-0
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 October 2008 - 22. December 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Ethoxycarbonylmethyl ethyl phthalate
- EC Number:
- 201-555-3
- EC Name:
- Ethoxycarbonylmethyl ethyl phthalate
- Cas Number:
- 84-72-0
- Molecular formula:
- C14H16O6
- IUPAC Name:
- ethoxycarbonylmethyl ethyl phthalate
- Test material form:
- liquid
- Remarks:
- clear, colourless, slightly viscous liquid
- Details on test material:
- Batch number: N-00103
Test material received: 01 September 2008
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- supplied by Harlan UK Limited, Bicester, Oxon, UK
- females were nulliparous and non-pregnant
- acclimatisation period of at least five days
- unique number, indelible ink-marking on the tail
- Age at start of the study: eight to twelve weeks of age
- bodyweight variation did not exceed ± 20% of the initial/mean boddyweight
- overnight fast before dosing and fast approx. three to four hours after dosing
- food and water ad libitum
HOUSING
- in groups up to four
- suspended solid-floor polypropylene cages furnished with woodflakes
- Temperature: 19-25°C
- Humidity: 30-70%
- Air exchange: at least fifteen changes per hour
- Light/Dark: 12/12 h
Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose of integrity of the study.
FOOD
- 2014 Teklad Global Rodent diet
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Gavage: metal cannula attached to a graduated syringe
Volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Sighting test: one female
Main test: four females - Control animals:
- no
- Details on study design:
- - Animals were dosed once only by gavage.
- Clinical observations were made 1/2, 1, 2 and 4 hours after dosing and once daily for fourteen days
- Morbidity and mortality checks twice daily
- Individual body weights recorded on day 0 (the day of dosing) and on days 7 and 14
- At the end of the observation period the animals were killed by cervical dislocation
- gross necropsy of all animals: external examination, opening of the abdominal and thoracic cavities
Results and discussion
- Preliminary study:
- - mortality: no deaths
- Clinical observation: no signs of systemic toxiicty
- Bodyweight: expected gains in bw over observation period
- Necropsy: no abnormalities were noted
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: Clinical observation: no signs of systemic toxiicty
- Gross pathology:
- no abnormalities were noted
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following OECD Guideline 420.
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
No animals died. No signs of systemic toxicity were observed. All animals showed expected gains in bodyweight. No abnormalties were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
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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.
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