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EC number: 273-960-3 | CAS number: 69300-15-8
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methyldecanenitrile
- EC Number:
- 273-960-3
- EC Name:
- 2-methyldecanenitrile
- Cas Number:
- 69300-15-8
- Molecular formula:
- C11H21N
- IUPAC Name:
- 2-methyldecanenitrile
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unknown
- IUPAC Name:
- Unknown impurities
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Identification: Frutonile
Description: Liquid
Batch Number: VE00002027 or 9000774502
Expiry Date: 19-Oct-2009
Storage conditions: At room temperature (range 20 +/- 5 °C, provided by Harlan Laboratories Ltd.), light protected.
Safety Precautions: Routine hygenic procedures (gloves, laboratory overall, goggles, fask mask). A full filtered, positive air-supplied respirator will be used during the inhalation process.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanRcc: WIST(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rationale: Recognised by international guidelines as a recommended rodent test system
Breeder: Harlan Laboratories Ltd.
Number of animals per group: 5 males and 5 females
Number of Groups: 1
Age at exposure: Males - 10 weeks, Females - 11 weeks
Body weight range at exposure: Males - 251.2 to 284.4 kg, Females - 217.0 to 223.2 kg (The weight variation did not exceed +/- 9% of the mean weight of the corresponding sex)
Identification: By unique cage numbers and individual unique tail numbers written with an inedlible felt-tip pen.
Acclimatization: Performed under Harlan Laboratories Study B68308 for eight dats under laboratory conditions, after clinical health examination. Only animals without any visible signed of illness were used for the study. A further observation of clinical signs was performed on the day of exposure, before exposure start.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Method: Inhalation by nose-only, flow-past exposure
Frequency of administration: single, 4-hour exposure period
Target aerosol concentration: slightly above 5 mg/L air
Rationale of aerosol concentration: The target concentration of 5 mg/L air (actual concentration of respirable substances) for 4 hours is the recommended concentration (OECD 403. 'Actue Inhalation Toxicity') - Duration of exposure:
- 4 h
- Concentrations:
- Target aerosol concentration: slightly above 5 mg/L air
- No. of animals per sex per dose:
- 5 males and 5 females
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 5.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: gravimetrically determined mean aerosol concentration
- Mortality:
- All animals survived the scheduled observation period
- Clinical signs:
- other: Slight to moderate salivation was observed during the whole course of exposure in all animals. In addition tachypnea, slightly to moderately decreased activity and slightly to moderately ruffled fur was noted in all animals at the end of the exposure peri
- Body weight:
- From test day 1 to test day 4, marginal to slight body weight loss was noted in all males and 4 females. The remaining female showed reduced body weight gain from test day 1 to test day 8. Thereafter, normal bosy weight development was recorded in these animals.
- Gross pathology:
- No macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Treatment of HanRcc: WIST(SPF) rats with Frutonile at a concentration of 5.3 mg/L for 4 hours resulted in no deaths.
Marginal body weight loss or stagnation of the body weight gain is not unusual in inhalation studies due to the restraining of the animals in the tubes during the nose-only exposure procedure. Nevertheless, the extent of the effects on the body weight on this study were considered to be mainly related to treatment with the test item although a contribution of restraining procedure is likely to have add the observed effect.
In conclusion, the LC50 of Frutonile obtained in this study was estimated to be greater than 5.3 mg/L air (gravimetrically determined mean aerosol concentration). There was no indication of relevant sex-related differences in toxicity of the test item.
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