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Diss Factsheets
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EC number: 946-570-2 | 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:
- weight of evidence
- Study period:
- 08 January-12 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 420 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on 10 July 2012/ signed on 30 November 2012)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Pine, Pinus pinaster, ext.
- EC Number:
- 290-166-2
- EC Name:
- Pine, Pinus pinaster, ext.
- Cas Number:
- 90082-75-0
- IUPAC Name:
- Essential oil of Pinus pinaster (Pinaceae) obtained from twigs and branches by steam distillation
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Pinus Pinaster oil
- Physical state: Extremely pale yellow liquid
- Analytical purity: Conforms to standard
- Purity test date: 12 December 2013
- Lot/batch No.: 1012/1
- Manufacturing date of the lot/batch: 10 October 2012
- Expiration date of the lot/batch: 10 October 2014
- Storage condition of test material: Stored at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 147-156 g (main study)
- Fasting period before study: Animals were fasted overnight before treatment and food was given approximately 3-4 h after dosing.
- Housing: Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL (for 300 mg/kg bw)
- Justification for choice of vehicle: Arachis oil BP was used because the test item was not dissolved/suspended in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw for 300 mg/kg bw dose; 2.31 mL/kg bw for 2000 mg/kg bw dose (specific gravity – 0.869)
DOSAGE PREPARATION (if unusual): Test item at 2000 mg/kg bw dose was used as concentrate. For 300 mg/kg bw dose, test item was freshly prepared as solution in arachis oil BP. The test item was formulated within 2 h of dosing and assumed that the formulation was stable for this duration.. - Doses:
- - Sighting study: 300 and 2000 mg/kg bw
- Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- - Sighting study: 1 female/dose (300 and 2000 mg/kg bw)
- Main study: 4 females (2000 mg/kg bw) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Each animal was checked for morbidity and mortality twice daily for 14 days. Clinical observations were made 0.5, 1, 2 and 4 h after dosing and then daily for 14 days.
Body weight: Body weight of each animal was recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes; on completion of the observation period, animals were killed by cervical dislocation and macroscopic examination was performed. - Statistics:
- None
Results and discussion
- Preliminary study:
- - No mortality and systemic toxicity were observed in the initial animal treated at 300 and 2000 mg/kg bw dose
- Animal showed expected gains in body weight over the observation period
- No abnormality was noted at necropsy
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- - No mortality was observed
- Clinical signs:
- - Hunched posture and increased salivation were observed in the additional four animals treated at 2000 mg/kg bw and one of these animals showed noisy respiration.
- Body weight:
- - All animals showed expected gains in body weight over the observation period
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.
- Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, a group of five female Wistar (RccHan™:WIST) rats were given a single oral dose of the test item Pinus Pinaster oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the main test, a sighting test was also conducted on 1 female rat/dose at 300 and 2000 mg/kg bw and animals were observed for 14 days. As no mortality occurred, the test item was administered to four additional animals at the dose level of 2000 mg/kg bw (main test).
No mortality was observed. No sign of systemic toxicity was observed in the initial animal treated at 300 and 2000 mg/kg bw dose level (sighting study). Signs of systemic toxicity observed in animals of the main study treated at a dose level of 2000 mg/kg bw were hunched posture, increased salivation and noisy respiration. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. In this study, the oral LD50 of Pinus Pinaster oil was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for Pinus Pinaster oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.
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