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EC number: 284-634-5 | CAS number: 84961-45-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ceratonia siliqua. Leguminosae.
- 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:
- 01 December 2017 - 15 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- September 2009
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- - Physical appearance: Dark brown to black liquid
- Storage of test material: At room temperature
Constituent 1
- Specific details on test material used for the study:
- pH: 5.0
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: males: 293 to 341 g; females: 190 to 213 g
- Fasting period before study: no
- Housing:
* on arrival and following assignment to the study: group housing (up to 5 animals of the same sex and exposure group/cage) in polycarbonate cages containing sterilized sawdust as bedding material
* during the study: individually housed and moved to an inhalation area in order to perform the exposure. Upon return to the cages, the bedding material was covered with a sheet to prevent suffocation.
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water: municipal tap-water was freely available to each animal via water bottle, except during exposure when there was no access to water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18-24 (actual: 19-20)
- Humidity (%): 40-70 (actual: 49-55)
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 December 2017 - 15 December 2017
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: Water (elix)
- Mass median aerodynamic diameter (MMAD):
- > 1 - < 4 µm
- Geometric standard deviation (GSD):
- > 1.5 - < 3
- Remark on MMAD/GSD:
- The indicated ranges are target values for MMAD and GSD.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the design of the exposure chamber is based on the directed flow nose only inhalation chamber
- Exposure chamber volume: not indicated
- Method of holding animals in test chamber: polycarbonate restraining tubes connected to the exposure chamber
- Source and rate of air: at least 1 L/min
- Method of conditioning air: not indicated
- System of generating particulates/aerosols: an aerosol was generated by nebulization of the test item (diluted 1:1 with water) with pressurized air. For this, the test item was transferred to a Collison nebulizer by means of a rotating pump (type VL500 digit, VERDER Lab Tec GmbH & Co. KG, Haan, Germany). The primary aerosol was diluted with pressurized air before it entered the exposure chamber. The mean total airflow was 10 L/min.
- Method of particle size determination: The particle size distribution was characterized twice during each exposure period. The samples were drawn with a flow of 2 L/min. from the test atmosphere through a tube mounted in one of the free animal ports of the exposure chamber. The samples were collected with an 8 stage Marple personal cascade impactor. Amounts of test item collected were measured gravimetrically. Subsequently the Mass Median Aerodynamic Diameter (MMAD) and the Geometric Standard Deviation (GSD) were determined based on OECD guidance document No 39.
Graphs of the cumulative mass of test item collected (percentage of total collected) against the cut points of the impactor stages were drawn on log-normal paper. When drawing the graphs more weight was given to the cut points where the cumulative mass sampled was within the range of 5 to 95%. The Mass Median Aerodynamic Diameter (MMAD), i.e. the particle size where 50% of the particle mass was borne by particles smaller than the MMAD and the σ84%, (the particle size where 84% of the particle mass was borne by particles smaller than the σ84% was read from the graph. The geometric standard deviation (gsd) was calculated as σ84% / MMAD.
- Treatment of exhaust air: not indicated
- Temperature and humidity in air chamber: measured at 30 minute intervals after initiation of exposure.
TEST ATMOSPHERE
- Brief description of analytical method used: The nominal concentration was calculated by dividing the amount of test item used by the volume of pressurized air (average air flow times exposure time) entering the exposure chamber used for exposure of the animals. Due to the small volume of the exposure chamber the equilibrium time was negligible. The volume of air was calculated from the average air flow (which was measured by means of thermal mass flow meters and recorded regularly, preferably in 30 minute intervals) and the exposure time.
- Samples taken from breathing zone: yes
VEHICLE: the test item was diluted in Elix water (1:1) with a specific gravity of 1.0.
CLASS METHOD
- Rationale for the selection of the starting concentration: the target concentration (5 mg/L) were based on the cut off concentration values specified in the UN and EC classification guidelines. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- In a stepwise manner: three animals of each sex were exposed to a test item target concentration of 5 mg/L. Based on the results, no more animals were exposed.
- No. of animals per sex per dose:
- Three male and three female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* body weights: on day 1 (pre exposure), 2, 4, 8 and 15.
* mortality: twice daily
* clinical observations during exposure: at least three times
* clinical observations post exposure: at periodic intervals on the day of exposure (at least two times) and once daily thereafter.
- Other examinations performed: macroscopic observations after necropsy - Statistics:
- No statistical analysis performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 other: mg/L (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: During exposure, quick breathing was seen in all animals and shallow respiration was noted for one animal at the first of the three observations (not presented in the table). After exposure, no clinical signs were noted.
- Body weight:
- Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- TEST ATMOSPHERE: see table 1
MMAD were
Any other information on results incl. tables
Table 1 Details on exposure concentrations
Dose (mg/L) |
TWA actual exposure concentration (mg/L) |
Nominal concentration (mg/L) |
Generation efficiency (%) |
MMAD (μm) |
|
1st measurement (gsd) |
2nd measurement + gsd |
||||
5 |
5.2 ± 0.09 |
22.3 |
47* |
3.3 (2.1) |
3.5 (2.0) |
* the ratio of actual and nominal concentration was 23.5% (generation efficiency) but as the test item was diluted in a 1:1 ratio, the generation efficiency of the test item was estimated at 47%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The inhalation 4h-LC50 of Carob Bean Extract in Wistar rats was established to exceed 5 mg/L. Based on this result, the substance is not classified for acute inhalation toxicity according to GHS and Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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