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Diss Factsheets
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EC number: 948-260-2 | 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:
- Aug- Oct 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt Baden-Württemberg
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
- EC Number:
- 701-295-5
- Molecular formula:
- C12 H18 O
- IUPAC Name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
Constituent 1
- Specific details on test material used for the study:
- Test material is the main constituent of the registered substance.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: [yes/no] : yes
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight) 173-182 g
- Fasting period before study: At least 16 h before administration
- Housing: Single housing in fully air-conditioned rooms
- Acclimatization: At least 5 d
- Feeding: R/M maintenance, low phytoestrogen; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany), ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per h): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- for 300 mg/kg bw treatment
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 g/100 mL
- Justification: Solution in corn oil Ph.Eur.
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw for doses of 300 mg/kg bw; 2.26 mL/kg bw for doses of 2000 mg/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor - Doses:
- 300 mg/kg bw; 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 female rats/ dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations of clinical signs: Several times on the day of administration and at least once a week
- Frequency of weighing: Day 0, 7d, 14d
- Necropsy of survivors performed: yes - Statistics:
- Calculations were performed using Microsoft Excel 2010 and checked with a calculator
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- no mortality occured
- Mortality:
- no mortality occured
- Clinical signs:
- other: Clinical signs in the second 2000 mg/kg test group: impaired general state and piloerection from hour 1 until hour 4 after administration, while dyspnea and cowering position were noted in these animals at hour 2. No clinical signs were observed after ex
- Gross pathology:
- There were no macroscopic pathological findings
Any other information on results incl. tables
Tab. 2: Mortality
Mortality |
|
||
Dose (mg/kg bw): |
2000 |
2000 |
300 |
Sex: |
female |
female |
female |
Administration: |
1 |
2 |
1 |
No. of animals: |
3 |
3 |
3 |
Mortality (animals): |
No mortality |
No mortality |
No mortality |
Tab. 3: Maximum incidence of clinical signs
Maximum incidence of systemic clinical signs |
|||
Dose (mg/kg bw): |
2000 |
||
Sex: |
female |
||
Administration: |
1 |
||
No. of animals: |
3 |
||
Animal No.: |
R300 |
R301 |
R302 |
Abnormalities: |
- |
- |
- |
|
|
|
|
Dose (mg/kg bw): |
2000 |
||
Sex: |
female |
||
Administration: |
2 |
||
No. of animals: |
3 |
||
Animal No.: |
R312 |
R313 |
R314 |
Abnormalities: |
|
|
|
Impaired general state: |
h1-h4 |
h1-h4 |
h1-h4 |
Piloerection: |
h1-h4 |
h1-h4 |
h1-h4 |
Dyspnea: |
h2 |
h2 |
h2 |
Cowering position: |
h2 |
h2 |
h2 |
|
|
|
|
Dose (mg/kg bw): |
300 |
||
Sex: |
female |
||
Administration: |
1 |
||
No. of animals: |
3 |
||
Animal No.: |
R281 |
R282 |
R283 |
Abnormalities: |
- |
- |
- |
* h - hour
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in female rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the test item (undiluted or preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females).
All animals gained weight in a normal range throughout the study period.
There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (9 females).
Clinical signs (impaired general state and piloerection, dyspnea and cowering position) were observed in the second 2000 mg/kg test group.
The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.
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