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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The members of the category are all alcohol esters of dicarboxylic acids. All category members are manufactured by reacting an alcohol (methanol, butanol or isobutanol) with single dicarboxylic acids, succinic, glutaric or adipic acids or mixtures of these acids. The ester bonds are effectively metabolised by the body releasing the component alcohols and acids. The difference between members involves 3 parameters: 1) the alcohol used to esterify the acids, 2) the length of the acid molecule (4C, 5C or 6C) and 3) the presence of individual esters or mixtures thereof.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
The toxicity profile of the members (ecotoxicity and human health toxicity and the environmental fate) is consistent. All have low acute toxicity potential, are not sensitising, are mildly irritating to eyes and upper respiratory tract (where vapour pressure allows exposure), are not genotoxic or clastogenic (in vivo) and have minimal systemic toxicity. Data are available predominantly for the methyl esters (individual and mixture), dibutyl adipate and diisobutyl esters (mixture). Within the category, read across is used to cover the higher tier human health toxicity studies predominantly.
See attached document with the justification for the category/read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of bis(2-methylpropyl) pentanedioate, bis(2-methylpropyl) hexanedioate, bis(2-methylpropyl) butanedioate
- IUPAC Name:
- Reaction mass of bis(2-methylpropyl) pentanedioate, bis(2-methylpropyl) hexanedioate, bis(2-methylpropyl) butanedioate
- Details on test material:
- - Name of test material (as cited in study report): COASOL
- Physical state: Liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: 22.9 %(w/w) Diisobutyl succinate; 56.4% (w/w) Diisobutyl glutarate; 19.1% (w/w) Diisobutyl adipate
- Purity test date: 07/Aug/2009
- Lot/batch No.: 50046869
- Expiration date of the lot/batch: 05/August/2010
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- COASOL: DBE-IB
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Age at study initiation: 8 - 12 weeks
- Fasting period before study: yes
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30- 70 %
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The 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:
- 5 females. Only females were used as they are typically more sensitive, and are the preferred choice when it is unknown if there is a sex difference in toxicity
- Control animals:
- no
- Details on study design:
- 1 animal dosed first, then in the absence of toxicity at the dose of 2000 mg/kg bw/day 4 additional animals were dosed with 2000 mg/kg bw/day. Clinical observations were made at 0.5, 1, 2, and 4 hours following dosing and then once daily for the remaining 14 days. Individual bodyweights were recorded at day 0 and day 7. At the end of observation period animals were euthenized by cervical dislocation and subject to gross necropsy consisting of external examination and opening of the abdominal and thoracic cavities. Any macroscopic abnormalities were noted.
- Statistics:
- not applicable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths
- Clinical signs:
- other: There were no clinical signs of toxicity
- Gross pathology:
- No abnormalities identified at necropsy
- Other findings:
- none
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- There were no deaths at the limit dose of 2000 mg/kg bw. Therefore this substance does not require classification for acute oral toxicity.
- Executive summary:
An acute oral toxicity study in female rats was conducted according to OECD TG 420 and in accordance with the Principles of Good Laboratory Practice (GLP). One female animal dosed first, then in the absence of toxicity at the dose of 2000 mg/kg bw/day four additional animals were dosed with 2000 mg/kg bw/day. Clinical observations were made at 0.5, 1, 2, and 4 hours following dosing and then once daily for the remaining 14 days. Individual bodyweights were recorded at day 0 and day 7. At the end of observation period animals were euthenized by cervical dislocation and subject to gross necropsy consisting of external examination and opening of the abdominal and thoracic cavities. Any macroscopic abnormalities were noted. There were no deaths and no clinical signs of toxicity, based on which the the substance does not require classification for acute oral toxicity.
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.
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