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EC number: 701-246-8 | 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: 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:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Nu-Film-17
- IUPAC Name:
- Nu-Film-17
- Reference substance name:
- Oligomerisation products of beta-pinene
- EC Number:
- 701-246-8
- Molecular formula:
- Variable (dimer = C20-H34)
- IUPAC Name:
- Oligomerisation products of beta-pinene
- Details on test material:
- Pinene oligomers content 91.1% w/v
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley, strain Crl: CD(SD) IGS-BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: Young adults
- Weight at study initiation: 200 - 300 g
- Housing: Animals housed individually in steel cages with a bedding of wood shavings
- Diet: Rat-Mouse Ganave (supplied by Distribuidora Horacio Izaguirre) ad libitum
- Water: tap water (dechlorinated by passage though activated charcoal) ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod: 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- A 2.7L 'only nasal' chamber was used as the inhalation chamber. A Respirex professional ultrasonic nebulizer was used to generate the liquid aerosol which was connected to the inhalation chamber by plastic tubing to generate 12 air changes per hour. The air from the chamber is extracted and fed through a treatment system containing carbon tetrachloride solution. The inhalation chamber was maintained under negative pressure throughout the exposure period using a vacuum pump (ECAM Aspirex) and an air flux meter to regulate the air litres/minute.
A group of 10 rats (5 male and 5 female) were exposed to an aerosol concentration of the test substance over a period of 4 hours. After exposure, residual test substance was removed from the facial area of each animal and were returned to their corresponding cages with food and water provided ad libitum. The aerosol particle size was determined though drop measurement, obtained from emulsifying the cloud generated in the inhalation chamber, in vaseline. The nominal concentration of the test substance was determined by dividing the total amount of the nebulized test substance (mg) by the total amount of air flowing through the chamber (litres).
The median aerodynamic diameter of the particles was determined to be 4.1 um and the standard deviation 1.60 um. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by IR analysis
- Duration of exposure:
- 4 h
- Concentrations:
- A nominal concentration of 4.64 mg/l was used (maximum achievable concentration, due to the physical-chemical properties of the test substance).
- No. of animals per sex per dose:
- 10 animals in total (5 male, 5 female)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations were conducted (these included any change to the skin and/or fur, eyes, mucous, respiratory, circulatory and autonomous and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed towards observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleepiness and coma). Animals were weighed prior to exposure to test substance and then at weekly intervals and at time of death or at test termination.
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.43 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.64 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortalities were observed in this study.
- Clinical signs:
- other: No signs of toxicity were observed in this study
- Body weight:
- No significant changes to body weight were observed
- Gross pathology:
- No abnormalities were observed
Any other information on results incl. tables
Table 1. Measured concentrations of test substance (determined by IR analysis)
Sample | Time (min) | Concentration (mg/l) |
1 | 20 | 4.12 |
2 | 60 | 4.52 |
3 | 120 | 4.4 |
4 | 180 | 4.56 |
5 | 240 | 4.55 |
Median analytical concentration: 4.43 mg/l
Standard deviation: 0.18 mg/l
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of this study, the inhalation LC50 in rats was determined to be >4.43 mg/l (measured concentration).
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