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EC number: 700-652-2 | CAS number: 1259300-69-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 13th, 2011 to January 11th, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4-{[3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoyl]oxy}butyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate
- EC Number:
- 700-652-2
- Cas Number:
- 1259300-69-0
- Molecular formula:
- C20H34O8
- IUPAC Name:
- 4-{[3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoyl]oxy}butyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate
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: almost 2 months old.
- Weight at study initiation: pretest body weight range was 211 - 239 g. The weight variation of the animals used did not exceed ±20% of the mean weight of the previously dosed animals.
- Fasting period before study: 16-20 hours prior to dosing.
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times per week.
- Diet: fresh PMI Rat Chow (Diet #5012) was freely available.
- Water: ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h light/dark cycle.
- Other: animal room was clean and vermin free.
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.
Dosing: initially, a single female Sprague Dawley rat was dosed orally at a dose level of 5000 mg/kg bw. Since the animal survived, two additional females were dosed at 5000 mg/kg bw. - Doses:
- 5000 mg/kg bw.
- No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: animals were observed at 15 minutes, 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Post Mortem: all animals were humanely sacrificed using CO2 following study termination and examined for gross pathology.
- Analysis of Data: an estimate of the LD50 was made based on the mortality occurring during the study.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- all three female rats survived the single 5000 mg/kg oral dose.
- Clinical signs:
- other: Wetness/soling of the anogenital area, piloerection, ataxia, splayed hind limbs, sensitivity to touch and few feces were observed.
- Gross pathology:
- The gross necropsy of all animals revealed no observable abnormalities.
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 (rat) > 5000 mg/kg bw
- Executive summary:
The acute toxicity effects of the substance and the determination of the test substance in rat was assessed according to EPA OPPTS 870.1100 and OECD Guideline 425 in compliance with GLP.
Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, two additional animals were dosed at 5000 mg/kg bw. Animals were observed at 15 minutes, 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were humanely sacrificed using CO2 following study termination and examined for gross pathology. No mortality was observed under the test conditions.
Under the conditions of the study, the LD50 of the test substance was > 5000 mg/kg bw.
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