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EC number: 282-013-3 | CAS number: 84082-68-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Myristica fragrans, Myristicaceae.
- 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
- Study period:
- 6 December 1984 - 19 December 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test was conducted according to EPA proposed guidelines for registering pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals: Federal Register (43) 163, August 22, 1978. 163 81.3, and equivalent to OECD Test Guideline 403,1981, under GLP Standards, and QA. Chemical identity of test substance is not reported.
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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Myristica fragrans, ext.
- EC Number:
- 282-013-3
- EC Name:
- Myristica fragrans, ext.
- Cas Number:
- 84082-68-8
- Molecular formula:
- Unspecified (UVCB)
- IUPAC Name:
- Nutmeg Oil (Myristica fragrans, ext.)
- Reference substance name:
- 84-215-01
- IUPAC Name:
- 84-215-01
- Details on test material:
- - Name of test material (as cited in study report): 84-215-01
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: confidential
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: no data
- Weight at study initiation: 190 to 220 (mean)
- Fasting period before study: no data
- Housing: placed in an individual wire mesh holding cage. The cages were made of stainless steel mesh (size 30.5 cm x 19 cm x 20 cm height) and were suspended on a movable rack. The rats remained in a holding room except for the 4-hour exposure.
- Diet: food (Scientific feeds LAD 1) ad libitum
- Water: tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Max. 24°C (SD 0.7) and min. 23°C (SD 0.9)
- Humidity (%): 46% (SD 7.7)
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks:
- 15 l/min.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure chamber made of perspex
- Exposure chamber volume: 0.13m3
- Method of holding animals in test chamber: The whole body exposure chambers used for the exposures were of square section and were fitted with pyramidal tops. Each chamber was divided by wire mesh partitions to provide 10 separate animal compartments. The rats (5 male and 5 female) were placed into separate compartments of the exposure chamber.
- Source and rate of air: concentric jet atomiser - clean air: 10 l/min.; diluent air: 15 l/min.
vapour generator - test substance: 0.26 ml/min.
- System of generating particulates/aerosols: The test vapour was generated using a Pyrex glass with a condenser through which warm water was passed and the delivery system of the test substance (injected into a glass concentric jet atomizer with a syringe pump). As the spray of the test substance passed through the condenser (kept at 48 °C), some of it evaporated and was passed through a glass tube and diluted to the appropriate concentration of 5.0 mg/l.
- Temperature, humidity, pressure in air chamber: The temperature in the exposure chamber was measured with a mercury bulb thermometer and recorded at the start of the exposure and at 30-minute intervals during the exposure. The chamber relative humidity was monitored continuously during exposure using a wet and dry bulb hygrometer and recorded at 30-minute intervals.Temperature (°C): Control group: 23.8 (0.75), Test group: 25.1 (0.46); Relative humidity: Control group: 34% (5.5%), Test group:45% (1.7%).
TEST ATMOSPHERE
- Brief description of analytical method used: Ten air samples were taken from the chamber during each exposure and analysed to determine the concentration of vapour from the test substance in the chamber atmosphere.The test atmosphere was drawn through a glass tube containing OV17 5% + 1% Dexil in order to trap the test vapour which was then thermally desorbed into a gas chromatograph equipped with flame ionisation detector. The areas of the peaks due to the test vapour were then used to calculate the atmospheric concentrations.
- Samples taken from breathing zone: no - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- The mean concentration of vapour from the test substance to which the rats were exposed was 4.85 mg/1 and the variation ((range x 100) / mean) was 23%. Measured concentrations are included in the field "any other information on materials and methods incl. tables".
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed continuously during exposure, at hourly intervals for 4 hours following exposure and at least twice daily during the observation period. In addition to the range of clinical signs normally recorded, behavioural parameters were scored or measured once daily for 3 days before exposure and daily throughout the observation period. Each animal was weighed on the day of dosing (Day 1) and on Days 2, 4, 7, 11 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical and behavioral signs, body weight, rectal temperatures, organ weights (liver, heart, kidneys, adrenals, and lungs), gross necropsy - Statistics:
- Analyses of variance were carried out on the following data: bodyweights, rectal temperatures, organ weights. Students' 't' distribution was used to compare the treatment means.
Results and discussion
- Preliminary study:
- Not relevant
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.9 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- No deaths were seen in any animal of the test article or air only control groups.
- Clinical signs:
- other: The clinical signs seen during exposure were consistent with the response to a mildly irritant aerosol and included salivation, lacrimation and adoption of an abnormal respiratory pattern and body posture. Peripheral vasodilation was also seen in 2/5 male
- Body weight:
- The rate of bodyweight gain for control and test groups was similar.
- Gross pathology:
- All rats were normal with the exception of one treated male rat. This rat had a few petechiae on the lung surface.
- Other findings:
- - Organ weights: No significant test article related effects are noted.
- Other observations: the following changes were considered spontaneous in origin and of no toxicological significance: Bronchiolitis/bronchiolar epithelial erosion/bronchiolar epithelial hyperplasia in 2 control rats (male, female) and 1 treated female rat. Focus of pneumonitis in 1 control female rat and 1 treated male rat.
Any other information on results incl. tables
Not relevant
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this acute inhalation toxicity study the 4-hour LC50 of Nutmeg oil in the rat is determined to be greater than 4.9 mg/1. Based on these results, the test substance does not need to be classified for acute inhalation toxicity according to the EU criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
- Executive summary:
This acute inhalation toxicity study in male and female rats was conducted according to a method equivalent to OECD test guideline 403. Two groups of 10 rats (5/sex/group) were exposed whole-body to either 4.9 mg/1 vapour from test article 84-215-01 (nutmeg oil) or air only for 4 hours as control. Ten air samples are taken and test article concentration is determined by gas chromatography. Animals are observed once per hour for the first 4 hours during exposure and at least twice daily for 14 days, thereafter. No deaths were seen in any animal of the test article or air only control groups. Test article related clinical signs to test article exposure are irritant effects, abnormal respiratory pattern and abnormal body position. A behavioural evaluation yields no significant effects for either group. Slightly lower body temperatures follow the exposure. No significant test article related effects are noted for the following parameters: body weight, organ weights, microscopic and macroscopic pathology. The 4-hour LC50 of Nutmeg oil in the rat is determined to be greater than 4.9 mg/1. Based on these results, the test substance does not need to be classified for acute inhalation toxicity according to the EU criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
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