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EC number: 248-655-3 | CAS number: 27776-21-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- EC Number:
- 248-655-3
- EC Name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- Cas Number:
- 27776-21-2
- Molecular formula:
- C12H22N6.2ClH
- IUPAC Name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- Test material form:
- solid: flakes
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Standard laboratory conditions. Air-conditioned with 10 - 15 air changes per hour, continuously monitored environmental conditions (temp. range: 22 ± 3 °C;
relative humidity range: 30 - 70 %). On some isolated occasions, the relative humidity in the animal room exceeded the upper limit of 70 %. This is considered to
have no impact on the scientific validity of the study. The light cycle was set to 12-hour fluorescent light / 12-hour dark cycle with at least eight hours music during the light period.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- > 1.89 - < 2.18 µm
- Geometric standard deviation (GSD):
- > 1.5 - < 3
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air
- Based on:
- other: gravimetrically determined mean aerosol concentration
- Exp. duration:
- 4 h
- Mortality:
- All animals exposed to 2.0 mg/L air survived the scheduled observation period. One female exposed to 5.1 mg/L air was found dead on test day 5. All other animals exposed to 5.1 mg/L air survived the scheduled observation period
- Clinical signs:
- other: Clinical signs were limited to the day of exposure. All animals of both groups showed slightly ruffled fur after exposure. Two males and four females exposed to 5.1 mg/L air additionally showed salivation during the second half of exposure. The animal whi
- Body weight:
- Between test days 1 and 2, reduced body weight gain or slight body weight loss was noted in all males exposed to 2.0 or 5.1 mg/L air. This continued in one male exposed to 5.1 mg/L air until test day 8. Thereafter, normal body weight development was noted in all males.
Between test days 1 and 4, reduced body weight gain or slight body weight loss was noted in all females exposed to 2.0 or 5.1 mg/L air. This continued in to females exposed to 2.0 mg/L air until test day 8 and in another two females exposed to 2.0 mg/L air until test day 15. - Other findings:
- Macroscopic Findings
No test item-related macroscopic findings were present at necropsy. All findings observed were within the range of spontaneous background lesions which may occasionally be recorded in rats of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the findings of this study, the LC50 for 4-hour exposure of Azo Initiator VA044 was greater than 5.1 mg/L air (gravimetrically determined mean aerosol concentration). Based on mortality and body weight data, females are considered to be more susceptible to the toxicity of the test item.
- Executive summary:
Treatment of RccHanTM:WIST(SPF) rats with Azo Initiator VA044 at gravimetrically determined mean concnentrations of 2.0 mg/L air and 5.1 mg/L air for 4 hours did not result in any deaths at 2.0 mg/L air. One female died on test day 5 after exposure to 5.1 mg/L air. Clinical signs of toxicity were limited to the day of exposure and no test item-related macroscopic findings were observed. Between test days 1 and 2, reduced body weight gain or slight body weight loss was noted in all males exposed to 2.0 or 5.1 mg/L air. This continued in one male exposed to 5.1 mg/L air until test day 8. Thereafter, normal body weight development was noted in all males. Between test days 1 and 4, reduced body weight gain or slight body weight loss was noted in all females exposed to 2.0 or 5.1 mg/L air. This continued in to females exposed to 2.0 mg/L air until test day 8 and in another two females exposed to 2.0 mg/L air until test day 15. Although body weight loss or stagnation of body weight gain is not unusual in inhalation studies due to the restraining of the animals in the tubes during nose-only exposure, the effect in females exposed to 2.0 mg/L air and in both sexes exposed to 5.1 mg/L air is considered to be test itemrelated due to the magnitude and duration of body weight loss observed. Based on the findings of this study, the LC50 for 4-hour exposure of Azo Initiator VA044 was greater than 5.1 mg/L air (gravimetrically determined mean aerosol concentration). Based on mortality and body weight data, females are considered to be more susceptible to the toxicity of the test item.
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