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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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Nov - 19 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Environmental Research, Republic of Korea
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of (7E)-undec-7-enal and (8E)-undec-8-enal and (9E)-undec-9-enal and (9Z)-undec-9-enal and undec-10-enal
- Molecular formula:
- C11H20O
- IUPAC Name:
- Reaction mass of (7E)-undec-7-enal and (8E)-undec-8-enal and (9E)-undec-9-enal and (9Z)-undec-9-enal and undec-10-enal
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- (Crl:CD(SD)), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8 weeks
- Weight at study initiation: 180.3 - 203.7 g
- Fasting period: overnight, approximately 16 h prior to dosing up to 4 h post dosing
- Housing: individually in stainless wire mesh cage, 260W×350D×210H (mm)
- Diet: Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), ad libitum
- Water: tap water filtered and irratiated by ultraviolet light, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 24.5
- Humidity (%): 45.7 - 66.8
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.37 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to low expected toxicity of the test substance, 2,000 mg/kg bw was selected as the starting dose (limit test) for this study based on the information supplied by the sponsor. - Doses:
- step 1 and 2: 2000 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: All animals were observed for mortality, general condition and clinical signs such as tremor, convulsions, salivation, diarrhea, lethargy and vocalisation (type, severity, time of onset and recovery) at 30 min after dosing and at 1, 2, 4 and 6 h after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14). The body weight was recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy (Day 14)
- Necropsy of survivors performed: yes - Statistics:
- Body weights and body weight gain: Calculation of group mean values and standard deviations.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths of animals at the dose of 2000 mg/kg bw throughout the study.
- Clinical signs:
- other: Mucous stool was observed in two animals of step 2 at 6 h after dosing and in all animals on Day 1 at 2000 mg/kg bw and disappeared on Day 2. This clinical sign was considered to be a test substance-related effect.
- Gross pathology:
- No visible findings were observed at gross pathology in any animal dosed with 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this acute oral toxicity study in rats an LD50 value of > 2000 mg/kg bw was found.
- Executive summary:
The purpose of this study was to assess the potential toxicity test item following a single oral dose administration to female Sprague-Dawley rats. Two dose groups of three females received:
Steps 1−2: A dose of 2,000 mg/kg bw was administered and no mortality was observed (Step 1). A second dose of 2,000 mg/kg bw was administered. Again, no mortality was observed (Step 2). The study was finished at that point.
There were no deaths of animals at 2,000 mg/kg bw. Mucous stool was observed in animals on the day of dosing and Day 1 at the dose of 2,000 mg/kg bw. This change disappeared on Day 2.
No test substance-related effects were observed in body weight data or necropsy findings in any of the animals dosed with 2,000 mg/kg bw.
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance was not classified according to the CLP regulation and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg bw.
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