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EC number: 244-449-2 | CAS number: 21573-31-9
- 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:
- 2017-08-16 to 2017-09-12
- 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Oct-7-enal
- EC Number:
- 244-449-2
- EC Name:
- Oct-7-enal
- Cas Number:
- 21573-31-9
- Molecular formula:
- C8H14O
- IUPAC Name:
- oct-7-enal
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Chemical name: Oct-7-enal (OEL)
- CAS no.: 21573-31-9
- EC-no.: not assigned
- Source and lot/batch No.of test material: Kuraray / 82725
- Expiration date of the lot/batch: 24 April 2018
- Molecular weight: 126.198 g/mol
- Purity: 95.4%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females: nulliparous and non-pregnant
- Age at study initiation: 8-11 wks
- Weight at study initiation: 161-182g
- Fasting period before study:
- Housing: group housed in IVC cages
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 °C
- Humidity (%): 55 +/-10%
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- no vehicle used, test article dosed as recieved.
MAXIMUM DOSE VOLUME APPLIED: awaiting confirmation
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 550 mg/kg bw, 2000 mg/kg bw
- No. of animals per sex per dose:
- 550 mg/kg bw: 1 animal
2000 mg/kg bw: 3 animals - Control animals:
- no
- Details on study design:
- One animal was dosed first at a dose of 550 mg/kg bw. As the animal survived, the dose for the next animal was increased to 2000 mg/kg bw following the recommendations of the corresponding statistical program (EPA AOT425Statpgm).
Each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision was based on the 48-hour survival pattern of all the animals up to that time. A combination of stopping criteria was used to keep the number of animals low.
The test was stopped following the dose recommendations and criteria given in the OECD statistical program AOT425Statpgm - Statistics:
- OECD statistical program AOT425Statpgm
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived to the scheduled necropsy
- Clinical signs:
- The most relevant clinical findings in the animal treated with the test item at a dose of 550 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid closure and alopecia.
The most relevant clinical findings in the animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and half eyelid closure. - Body weight:
- No effect on body weight was observed
- Gross pathology:
- At necropsy, no macroscopic findings were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study the rat acute oral LD50 was > 2000 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, oct-7-enal has no obligatory labelling requirement for acute oral toxicity and is unclassified.
- Executive summary:
The test article was administered undiluted orally via gavage, initially at 550 mg/kg bw to a single female using the up and down procedure. As the animal survived the dose for the next animal was increased to 2000 mg/kg bw. Each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision was based on the 48-hour survival pattern of all the animals up to that time. A combination of stopping criteria was used to keep the number of animals low. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period. The most relevant clinical findings in the animal treated with the test item at a dose of 550 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid closure and alopecia. The most relevant clinical findings in the animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and half eyelid closure. There were no treatment related effect on body weight and no abnormalities were recorded at necropsy in rats in either group. Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, oct-7-enal has no obligatory labelling requirement for acute oral toxicity and is unclassified.
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