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EC number: 662-772-0 | CAS number: 25601-41-6
- 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:
- 2011-10-06 to 2011-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- methyl dec-9-enoate
- EC Number:
- 662-772-0
- Cas Number:
- 25601-41-6
- Molecular formula:
- C11H20O2
- IUPAC Name:
- methyl dec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): 9-decenoic acid, methyl ester (9DAME)
- Physical state: Clear colourless liquid
- Purity: 99%
- Lot/batch No.: 184-109
- Date received: 2011-04-01
- Storage condition of test material: Room temperature in the dark under nitrogen
Constituent 1
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, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 164 ± 20 %
- Fasting period before study: Overnight immediately prior to dosing and 3-4 hours after dosing
- Housing: Groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to 2014C Teklad Global Rodent Diet supplied by Harlan Laboratories UK Ltd, Oxon, UK
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 ºC
- Humidity: 30 to 70 %
- Air changes: At least 15
- Photoperiod: 12 hours light (06:00 to 18:00) and 12 hours dark controlled by a time switch
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- 300 mg/kg dose level
- Details on oral exposure:
- EXPERIMENTAL PREPARATION
- Specific gravity of the test material was determined and used to calculate the appropriate dose volume.
- The test material was formulated within two hours of being applied to the test system and it was assumed that the substance was stable for that period of time.
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation and that decision was noted in the GLP compliance statement. - Doses:
- - Initial investigation: single dose of 300 mg/kg as a dose volume of 10 mL (30 mg/mL).
- Second investigation: single dose of 2000 mg/kg (2.26 mL/kg; specific gravity 0.885).
- Third investigation: single dose of 2000 mg/kg (2.26 mL/kg; specific gravity 0.885). - No. of animals per sex per dose:
- - Initial investigation: one
- Second investigation: one
- Third investigation: four - Control animals:
- no
- Details on study design:
- ANIMALS AND ANIMAL HUSBANDRY
- Animals were randomly allocated to cages on receipt.
- The females were nulliparous and non-pregnant.
- Animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
- 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 or integrity of the study.
- Animals were provided with environmental enrichment items that were considered not to contain any contaminant at a level that could affect the purpose or integrity of the study.
PROCEDURE
- In the absence of data on test material toxicity, 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.
- In the absence of mortality at a dose level of 2000 mg/kg, a further group of animals was treated. - Statistics:
- - Data evaluations included the relationship, if any, between the animals' exposure to test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
- Motality data was used to obtain an estimate of the acute oral median lethal dose (LD50) of the test material.
Results and discussion
- Preliminary study:
- - No toxicity was observed at a dose level of 300mg/kg
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at a dose level of 300 mg/kg or 2000 mg/kg
- Clinical signs:
- other: - No signs of clinical toxicity were noted during the observation period following treatment at 300 mg/kg or 2000 mg/kg
- Gross pathology:
- No abnormalities were noted at necropsy following dosing at 300 mg/kg and 2000 mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- (EU CLP)
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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