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EC number: 606-744-8 | CAS number: 213464-77-8
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Deviations: some minor deviations from the study plan were present but considered not to affect the validity of the study results.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test material:
IR5878
Batch number: FCF/T/168-00 (ex 20525/03/9)
Purity: 98.54 ± 0.51 %
Test animals
- Species:
- rat
- Strain:
- other: Male and Female HanIbm: WIST (SPF) rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Species and Strain: Male and Female HanIbm: WIST (SPF) rats
Age: 6 weeks (males); 9 weeks (females)
Body weight: 180.4 ÷ 194.7 g (males); 183.3 ÷ 189.0 g (females)
Housing: 5 animals per Makrolon type-4 cage with wire mesh tops and standard softwood bedding.
Feed: pelleted standard Kliba 3433, rat maintenance diet ad libitum (except during the exposure period, when they were restrained in exposure tubes). Community tap water from Füllinsdorf ad libitum (except during the exposure period, when they were restrained in exposure tubes).
Environmental conditions:
Temperature and humidity measured during the study were 22 ± 3°C and 30 ÷ 70%, respectively.
Light: 12 hours fluorescent light and 12 hours dark (music during the light period).
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Mass median aerodynamic diameter (MMAD):
- ca. 3.02 µm
- Geometric standard deviation (GSD):
- ca. 2.94
- Details on inhalation exposure:
- IR5878 was administered to 5 male and 5 female HanIbm: WIST (SPF) rats by nose-only, flow-past inhalation exposure for a single continuous 4-hour period, followed by an observation period of 14 days.
IR5878 aerosol was generated using a CR 3020 powder generator feeding a micronising Jet-Mill. The aerosol generated was then discharged into the exposure chamber through a 63Ni charge neutraliser with a target Mass Median Aerodynamic Diameter (MMAQD) of 1 to 4 μm. Based on preliminary technical trials which showed that the exposure system blocked after about 1 hour at concentration of about 3 mg/L air, two exposure systems were prepared to generate an aerosol concentration of about 2 mg/L. The second aerosol generator/Jet-Mill replaced the first one after 2 hour and 10 minutes of exposure - remaining the animals in the same tower. The changeover took one minute to complete and this time was added to the end of exposure.
The exposure conditions (range of temperature, humidity and oxygen content) measured during the exposure were acceptable. The mean gravimetric concentration was the highest technically achievable concentration.
The animals were examined for mortality, clinical signs and body weight for 14 days. On day 15 the rats were killed by i.p. overdosage of pentobarbitone and examined macroscopically. - Duration of exposure:
- ca. 4 h
- Concentrations:
- Based on preliminary technical trials which showed that the exposure system blocked after about 1 hour at concentration of about 3 mg/L air, two exposure systems were prepared to generate an aerosol concentration of about 2 mg/L. The second aerosol generator/Jet-Mill replaced the first one after 2 hour and 10 minutes of exposure - remaining the animals in the same tower. The changeover took one minute to complete and this time was added to the end of exposure.
- No. of animals per sex per dose:
- IR5878 was administered to 5 male and 5 female HanIbm: WIST (SPF) rats by nose-only, flow-past inhalation exposure for a single continuous 4-hour period, followed by an observation period of 14 days.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.19 mg/L air
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities were observed in this test.
- Clinical signs:
- other: No clinical signs were observed in both sexes
- Body weight:
- Body weight was unaffected by treatment.
- Gross pathology:
- At gross necroscopy no macroscopic changes were observed in any animal.
Any other information on results incl. tables
In Table 5.2-1 and 5.2-2 are summarised the technical conditions measured during the exposure and the atmosphere analysis.
Table 5.2-1 Exposure conditions measured during the exposure
Temperature (°C) |
Relative humidity (%) |
O2Concentration (Vol. %) |
22.4 ±(n=9) |
6.4 ± 1.96 (n=9) |
20.7 ±(n=9) |
Table 5.2-2 Data on the test atmosphere analysis
Group |
Test atmosphere concentration (mg/L) |
MMAD (µm) and [GSD] |
|
Nominal |
Gravimetric ± SD |
||
1 |
4.641 |
2.190 ± 0.047 (n=5) |
3.02 [2.94] |
MMAD: Mass Median Aerodynamic Diameter
GSD: Geometric Standard Deviation
No mortalities were observed in this test.
No clinical signs were observed in both sexes.
Body weight was unaffected by treatment.
At gross necroscopy no macroscopic changes were observed in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute inhalation LC50 of IR5878 in rats was estimated to be greater than the highest technically achievable aerosol concentration of 2.190 mg/L air (gravimetrically determined mean aerosol concentration).
- Executive summary:
IR5878 was administered to 5 male and 5 female HanIbm: WIST (SPF) rats by nose-only, flow-past inhalation exposure for a single continuous 4-hour period, followed by an observation period of 14 days.
The acute inhalation LC50of IR5878 in rats was estimated to be greater than the highest technically achievable aerosol concentration of 2.190 mg/L air (gravimetrically determined mean aerosol concentration).
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