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Diss Factsheets
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EC number: 247-891-4 | CAS number: 26658-19-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 2010-04-12 to 2010-04-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sorbitan laurate
- EC Number:
- 215-663-3
- EC Name:
- Sorbitan laurate
- Cas Number:
- 1338-39-2
- IUPAC Name:
- 1,4-anhydro-6-O-dodecanoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan Laurate
- Physical state: yellow turbid viscous liquid
- Analytical purity: >80%
- Lot/batch No.: 0000357933
- Expiration date of the lot/batch: 27 October 2011
- Storage condition of test material: stable at RT in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young adult animals were selected (approximately 12 weeks old)
- Weight at study initiation: Animals used within the study were of approximately the same age and body weight variation did not exceed +/- 20% of the sex mean
- Housing: Group housing of five animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) except during exposure to the test substance
- Water (e.g. ad libitum): Free access to tap water except during exposure to the test substance
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 19.8 – 21.5)
- Humidity (%): 40-70 (actual range: 34 - 53)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983)
- Exposure chamber volume: nose only
- Method of holding animals in test chamber: The chamber consisted of three animal sections with eight animal ports each (appendix 1, figure 1). Each animal port had its own atmosphere inlet and exhaust outlet. The animals were placed in restraining tubes and connected to the animal ports.
- Source and rate of air: at each animal port the theoretical air flow was at least 1 L/min
- System of generating particulates/aerosols: stainless steel nebulizer (type 156.000.16.16, Lechler, Metzinger, Germany)
- Method of particle size determination: The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were determined twice.
Temperature, humidity, pressure in air chamber: The actual temperature of the atmosphere was between 20.9 and 21.2°C and relative humidity was between 30.1 and 32.9%.
TEST ATMOSPHERE
- Brief description of analytical method used: Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber. Samples were drawn through a glass fiber filter (type APFC04700, Millipore, Billerica, MA, USA). The collected amount of the non-volatile test substance in the air sample was measured gravimetrically.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
The MMAD was 4.6 and 4.7 µm, respectively and the gsd was 2.0 and 2.1, respectively
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The target concentration was based on the EC and UN classification guidelines.
Agglomeration of aerosol particles at this high concentration might have resulted in the MMAD values to fall outside the recommended range of 1 - 4 µm. The MMAD determined (4.6 and 4.7µm) just exceeded this range. Since the gsd (2.0 and 2.1) determined during the actual exposure indicated that the aerosol was polydisperse and since approximately 40% of the particles were smaller than 4 µm,it can be assumed that sufficient deposition in the lower respiratory tract occurred during the exposure. Further testing at a lower concentration was considered but for animal welfare reasons not conducted. The exposure to the limit concentration of 5 mg/L with a slightly larger MMAD was considered of greater value than an exposure to a lower level with a MMAD closer to or in the recommended range. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The actual concentration was determined nine times during the exposure period. Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber.
- Duration of exposure:
- 4 h
- Concentrations:
- 5 mg/L
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Three times during exposure for mortality, behavioural signs of distress and effects on respiration, days 1 (pre-treatment), 2, 4, 8 and 15 for body weight changes
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were sacrificed at the end of the observation period by an intraperitoneal injection with Euthasol ® (AST Farma BV, Oudewater, The Netherlands) and subsequently exsanguinated. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded. Particular attention was given to any changes in the respiratory tract.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 000 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: During exposure, slow breathing was observed among several animals at approximately 3 hours after start of exposure. After exposure, clinical signs recorded among all animals between Days 1 and 5 included lethargy, ventro-lateral recumbency, hunched postu
- Body weight:
- Overall body weight gain in males and females were within the range expected for rats of this strain and age used in this type of study.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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