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EC number: 700-637-0 | CAS number: 902272-78-0
- 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
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- Water solubility
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 15th to December 30th, 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study is 1
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- adopted October 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- EC Number:
- 228-536-2
- EC Name:
- Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate
- Cas Number:
- 6290-17-1
- Molecular formula:
- C9H16O4
- IUPAC Name:
- Ethyl (2,4-dimethyl-1,3-dioxolan-2-yl)acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAGE Labs, Boyertown, PA.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: 2 months
- Weight at study initiation: 180-218 g.
- Fasting period before study: 16-20 h
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet: fresh PMI rat chow.
- Water: ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
The animal room reserved exclusively for rats on acute tests, was temperature-controlled, had a 12 h light-dark cycle, and was kept clean and vermin free.
IN-LIFE DATES: From:23 Nov, 2011 To: 30 Dec, 2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test substance was used as received and the dose was based on the sample weight as calculated from the specific gravity.
Initially a single rat was dosed orally by syringe and dosing needle. Since the animal survived, four additional females were dosed. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: at 15 min, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors.
- Necropsy of survivors performed: yes by using CO2.
- Other examinations performed: Systemic and necropsy observation
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three out of five female rats survived. The deaths occurred between 2 hours postdose and on Day 1.
- Clinical signs:
- other: Pre-death physical signs included wetness of the anogenital area, prostration, ataxia and piloerection. Among the survivors, abnormal physical signs included lethargy, wetness of the nose/mouth area, ataxia, piloerection, wetness of the anogenital area, p
- Gross pathology:
- Necropsy findings revealed wetness of the nose/mouth area, soiling and wetness of the anogenital area, pale areas and redness of the stomach, as well as red and yellow areas on the intestine. There were no necropsy findings in the survivors.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- LD50 > 5000 mg/kg bw.
- Executive summary:
The acute toxicity of the test material after the oral exposure to rats was evaluated in a limit test according to the OECD Guideline 425 and EPA OPPTS 870.1100 and n compliance with GLP.
Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, four additional animals were dosed at 5000 mg/kg bw. The animals were observed for 14 days for mortality, clinical signs, body weights were recorded and the surviving animals were necropsied.
Three out of five female rats survived the single 5000 mg/kg bw oral dose.
LD50 > 5000 mg/kg bw.
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