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EC number: 814-965-8 | CAS number: 22094-84-4
- 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:
- 28 February 2018 to 9 April 2018 (Study initiation to Experimental completion)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 5-octylbicyclo[2.2.1]hept-2-ene
- EC Number:
- 814-965-8
- Cas Number:
- 22094-84-4
- Molecular formula:
- C15H18 C15H26
- IUPAC Name:
- 5-octylbicyclo[2.2.1]hept-2-ene
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Materia Inc.
- Lot/batch No.of test material: RP367_ONB-D
- Expiration date of the lot/batch: 9 August, 2018
- Purity test date: 9 August 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (Ambient), protected from light (as a precautionary measure). Kept in original container, as supplied by the Sponsor.
- Stability under test conditions: Assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent/vehicle: The test item is a liquid and was tested undiluted..
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan : WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: Minimum: 148.4g Maximum: 181.0g
- Fasting period before study: Rats were fasted overnight prior to dosing and until three hours post-dose.
- Housing: Polypropylene rat cages covered with a stainless steel grid top were used. Autoclaved clean rice husk was used as bedding material. Wooden chew blocks were provided as enrichment material.
- Diet (e.g. ad libitum): Teklad Certified Global High Fiber Rat/Mice Feed manufactured by Envigo, USA.
- Water (e.g. ad libitum): UV sterilized water filtered through a Reverse Osmosis water filtration system.
- Acclimation period: 6 to 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 56 to 66%
- Air changes (per hr): Minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): The photoperiod was 12 hours artificial light and 12 hours darkness, light hours being 06:00 h – 18:00 h (photoperiod was maintained through an automatic timer)
IN-LIFE DATES: From: To: 7 March 2018 to 9 April 2018 (Experimental start to experimental completion)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: The individual dose volume was adjusted according to body weight, dose level and density but will not normally exceed 10 mL/kg body weight. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe or Hamilton syringe.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no toxicological information was available on the test item, in accordance with OECD 423, Annex 2c a starting dose of 300 mg 5-octyl-2-norbornene/kg bw was selected as the initial test dose. - Doses:
- 300 mg 5-octyl-2-norbornene/kg bw
2000 mg 5-octyl-2-norbornene/kg bw - No. of animals per sex per dose:
- Twelve females (nulliparous and non-pregnant)
Two set of three female rats doses at 300 mg 5-octyl-2-norbornene/kg bw
Two sets of three females rats doses at 2000 mg 5-octyl-2-norbornene/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 5-6 hours post-administration on the day of dosing. Rats were observed twice a day for morbidity and mortality for a period of 14 days following oral dosing. Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes. At the end of the 14 day observation period, all rats were euthanised by carbon dioxide asphyxiation and were subjected to gross pathological examination, consisting of external examination and opening of the abdominal and thoracic cavities.
- Other examinations performed: Clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw
- Clinical signs:
- No clinical signs were observed in any rat treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw.
- Body weight:
- Normal gain in body weight was observed in all rats treated with 300 or 2000 mg 5-octyl-2-norbornene/kg bw.
- Gross pathology:
- Necropsy (Macroscopic Findings)
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal: Visceral examination of terminally sacrificed rats did not reveal any abnormality.
In absence of any pathological lesion in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose levels used in the present study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50 cut-off value) 5-octyl-2-norbornene in Wistar rats was found to be 5000 mg/kg body weight.
Based on the results of this study, the classification for 5-octyl-2-norbornene is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals (GHS 2017) : Category 5 or Unclassified
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