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EC number: 452-570-9 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 15, 1994 - February 3, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale
- Weight at study initiation: 228-239 g (males), 220-235 g (females)
- Housing: individually (in suspended stainless steel caging with mesh floors)
- Diet: Purina Rodent Chow
- Water: Tap water (ad libitum except during exposure)
- Acclimation period: 23 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 23.9
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 2.2 µm
- Geometric standard deviation (GSD):
- 1.93
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Rectangular whole body perspex chamber with prechamber operated under slight negative pressure
- Exposure chamber volume: 150 L
- Source and rate of air: Approximately 20 liters per minute (Lpm) was supplied from a compressed gas cylinder (Airco #3001) of dry, breathing-grade air to the spray atomization nozzle. Compressed airflow was measured with a Dwyer Rotameter Model #VFB (0-40 Lpm). Approximately 20.6 Lpm of filtered conditioned room air was supplied as diluent air. Room airflow was measured with an Omega Mass Flow Meter, Model #FMA 5613. Chamber airflow was monitored throughout the exposure period and recorded periodically. Total airflow ranged from 40.3 to 40.7 with a mean of 40.6 Lpm,
- System of generating aerosols: The test atmosphere was generated using a 1/4 inch JCO atomizer, FC4 fluid cap and 1502 air cap (Spraying Systems Inc.). Compressed air was supplied at 25 psi. The test substance was metered to the atomization nozzle through Size 14 Master Flex Tygon tubing, using a Master Flex Pump Model 7520-35.
- Method of particle size determination: An eight-stage Andersen cascade impactor was used. Samples were withdrawn from the breathing zone of the animals on two occasions. The filter paper collection stages were weighed before and after sampling to determine the mass collected at each stage. The aerodynamic mass median diameter and geometric standard deviation were determined graphically using two cycle logarithmic probit axes.
- Temperature, humidity, pressure in air chamber: 21.7-23.3°C, 40-45%, 25 psi
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn on eight occasions from the breathing zone of the animals. Samples were collected using 25 mm glass fiber filters (GF/B Whatman) in filter holders attached by % inch tygon tubing to a General Electric vacuum pump Model 5KH10GGR28. Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. The collections were carried out for 3 minutes at airflows of 4 Lpm. Sample airflows were measured using an Omega Flow Meter Model #FMA 5610.
- Samples taken from breathing zone: yes
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.12 mg/L (gravimetric chamber concentration)
10.93 mg/L (nominal concentration) - No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 50 days
- Frequency of observations and weighing: Individual weights of the animals were recorded just prior to test substance exposure (initial) and again on days 7, 14, 21, 28, 35, 42 and 49 or after death. Cage-Side observations were made at least every 30 minutes during exposure, upon chamber removal and at least once daily thereafter for 50 days.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology (lung tissue)
Results and discussion
- Preliminary study:
- Prior to initiation of the full inhalation study, pre-test trials were conducted to establish generation procedures for achieving as closely as possible the desired (2.0 mg/L) or highest possible chamber concentration and desired particle size distribution (mass median aerodynamic diameter less than or equal to 4/ µm). The exposure procedures and atomization equipment used were based on results of pre-test trial number 2 which provided a gravimetric concentration of 2.0 mg/L and a mass median aerodynamic diameter of 2.1 µm.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.12 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One male animal died on test day 11.
- Clinical signs:
- other: In chamber animal observation included ocular and nasal discharge, facial staining, irregular respiration, dyspnea, gasping, hunched posture and hypoactivity. Upon chamber removal, similar clinical signs persisted in all animals. Within several days o
- Body weight:
- Transient body weight loss was noted during the study.
- Gross pathology:
- Gross necropsy of the decedent revealed discoloration of the lungs, gastro intestinal tract and liver, gaseous distention of the gastrointestinal tract, edema of the lungs and retraction of the testes into the abdominal cavity. Gross necropsy findings at terminal sacrifice were generally unremarkable. Apart from red lung discoloration which is consistent with euthanasia by CO2 inhalation, all tissues and organs appeared normal.
- Other findings:
- - Histopathology: Histological evaluation of the lung tissue of the survivors revealed pulmonary congestion: the presence of alveolar macrophages; the accumulation of mucous in the bronchi and bronchioles; and chronic interstitial inflammation. Although the congestion may have been due to the euthanasia procedure, it along with interstitial inflammation may have resulted from exposure to a very mild irritant.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of testing, the single exposure Acute Inhalation Toxicity LC50 of the test substance is greater than 2.12 mg/L.
- Executive summary:
An Acute Inhalation Toxicity test according OECD Guideline 403 was conducted with rats to determine the potential of the test item to produce toxicity via the inhalation route.
After establishing the desired generation procedures during pre-test trials, ten healthy rats were exposed to the test atmosphere for 4 hours. Chamber concentration and particle size distribution of the test substance were determined periodically during the exposure period. The animals were observed for signs of gross toxicity and mortality at least once daily for 50 days. Bodyweights were recorded just prior to exposure and again or days 71 4, 21, 28, 35, 42 and 49 or after death. Gross necropsies were performed on all animals. The lungs of all survivors were removed at terminal sacrifice, preserved in formalin and evaluated histopatholggically.
One male died on day 11 of the study. All other animals survived exposure to the test atmosphere. The gravimetric chamber concentration was 2.12 mg/L. Based on graphic analysis of the particle size distribution as measured with an Anderson Cascade Impactor, the mass median aerodynamic diameter was estimated to be 2.2 µm.
In chamber animal observations included ocular and nasal discharge, facial staining, irregular respiration, dyspnea, gasping, hunched posture and hypoactivity. Upon chamber removal, similar clinical signs persisted in all animals. Within several days of exposure animals also developed piloerection, rales, emaciation, ano-genital staining and an unthrifty appearance. Prior to death, the decedent exhibited reduced food consumption, reduced fecal volume and abdominal distention. Transient signs of abnormal respiration were noted in several rats for an extended period of time. In order to assess the reversal of symptoms, the observation period was extended to 50 days. Although clinical signs persisted and transient bodyweight loss was noted during the study, all surviving rats gained weight over the entire 50 day observation period. Gross necropsy of the decedent revealed discoloration of the lungs, gastro-intestinal tract and liver, gaseous distention of the gastro-intestinal tract, edema of the lungs and retraction of the testes into the abdominal cavity. Gross necropsy findings at terminal sacrifice were generally unremarkable. Apart from red lung discoloration which is consistent with euthanasia by CO2 inhalation, all tissues and organs appeared normal. In order to further investigate the abnormal respiratory findings noted during the observation period, the lungs of all surviving animals were removed at gross necropsy and preserved in neutral buffeted formalin. Histological evaluation of the lung tissue revealed pulmonary congestion: the presence of alveolar macrophages; the accumulation of mucous in the bronchi and bronchioles; and chronic interstitial inflammation. Although the congestion may have been due to the euthanasia procedure, it along with interstitial inflammation may have resulted from exposure to a very mild irritant.
Based on the results of testing, the single exposure Acute Inhalation Toxicity LC50 of the test substance is greater than 2.12 mg/L.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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