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EC number: 619-946-6 | CAS number: 890707-29-6
- 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:
- supporting study
- Study period:
- 27.04.2009 - 28.08.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan Agricultural Chemicals Regulation Laws 2-1-3 Notification 12 Nousan 8147 and Notification 13 Seisan 1739
- Version / remarks:
- 2000 & 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
Test material
- Reference substance name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Cas Number:
- 890707-29-6
- Molecular formula:
- C10H11N3O
- IUPAC Name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- The test material was milled to a fine particle size specifically for use in the inhalation study
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: Approximately 8-9 weeks old
- Weight at study initiation: 230–322 g for males; 180–234 g for females
- Housing: Animals were housed individually in solid bottom caging with bedding.
- Diet: PMI Nutrition International, LLC Certified Rodent LabDiet (#5002), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): Not recorded
- 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
Chamber atmospheres were generated by suspension of the test substance in air with a Fluid Energy Processing model 00 jetmill. The test substance was metered into the jetmill with a K-Tron model T-20 Twin Screw volumetric feeder. Filtered, high-pressure air, metered into the jetmill, carried the resulting atmosphere through a 2-L glass cyclone and into the 34 L exposure chamber. The atmospheric concentration of the test substance was determined by gravimetric analysis at approximately 30-minute intervals during the exposure period. Samples to determine particle size distribution were taken during the exposure with a Sierra® Series 210 cyclone preseperator/cascade impactor and Sierra® Series 110 constant flow air sampler. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.2 mg/L and 5.6 mg/L of the test substance
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Two groups of 5 male and 5 female rats each were exposed to mean aerosol concentrations of either 2.2 mg/L or 5.6 mg/L of the test substance suspended in air for a single 4-hour period. During exposure, animals were individually restrained in perforated stainless steel cylinders with conical nose pieces. The restrainers were inserted into a polymethylmethacrylate faceplate attached to the exposure chamber so that the nose of each animal extended into the exposure chamber. Animals were observed for mortality and response to alerting stimuli during the exposure and observed for mortality and clinical signs of toxicity immediately after they were removed from the restrainers following exposure. During a 14-day post exposure period, all surviving rats were observed each day for mortality, were weighed test Days 0,1, 2, 3, 4, 7 and 14 and observed for clinical signs of toxicity daily during the recovery period. At the end of the 14-day recovery period, all surviving animals were necropsied and all animals were examined for gross pathological changes.
- Statistics:
- The data did not warrant statistical analysis.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No animals died following the 2.2 mg/L test substance exposure. One day following the 5.6 mg/L test substance exposure one female rat was found dead and 2 days following the 5.6 mg/L exposure one male rat was found dead. All remaining animals from the 5.6 mg/L exposure survived to the 14 day post exposure recovery period.
- Clinical signs:
- lethargy (hypoactivity)
- Remarks:
- Following the 5.6 mg/L exposure, 2 females demonstrated lethargy 2 days post-exposure which resolved by 3 days post-exposure. Following the 2.2 mg/L exposure, 2 females showed hypo-activity on day one post-exposure which resolved by 2 days post-exposure.
- Body weight:
- One day following the exposures, male and female rats demonstrated body weight losses of up to 36.5 g and 26.9 g, respectively. All surviving animals demonstrated body weight gains by 4 days post-exposure.
- Gross pathology:
- No test substance-related gross lesions were observed at necropsy in either exposure group.
Any other information on results incl. tables
Table 2: Concentrations, mortality/animals treated, inhalation LC50
Concentration (mg/L) | Males (a) | Females (a) | Combined (a) |
2.2 | 0/5 | 0/5 | 0/10 |
5.6 | 1/5 | 1/5 | 2/10 |
Inhalation LC50: | >5 mg/L | >5 mg/L | >5 mg/L |
(a) Number of animals died/number of animals in exposure group
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the acute inhalation LC50 for the test substance in rats was >5.6 mg/L for both males and females.
- Executive summary:
The acute inhalation toxicity of the test substance was investigated according to the OECD Guideline 403.
Two groups of 5 male and 5 female Crl:CD(SD) rats were exposed nose-only for a single 4-hour period to the test substance in air. The test substance is a solid/powder at room temperature and aerosol atmospheres were generated by suspending the test substance in air. Airborne concentrations of the test substance were determined by gravimetric analysis. Animals were weighed and observed for clincial signs of toxicity during a 14-day recovery period.
Rats were exposed to mean aerosol concentrations of either 2.2 ± 0.5 or 5.6 ± 1.3 mg/L test substance (mean ± standard deviation). The mean mass median aerodynaic diameters ± geometric standard devation for the 2.2 and 5.6 mg/L exposure atmospheres were 2.1 μm ± 1.9 and 2.6 μm ± 2.0, respectivley.
No mortalities were observed following the 2.2 mg/L exposure while 1 male and 1 female rat died within 2 days following the 5.6 mg/L exposoure.
One day following the exposures, male and female rats demonstrated body weight losses of up to 36.5 g and 26.9 g, respectively. All surviving animals demonstrated body weight gains by 4 days post-exposure.
Immediately following the 5.6 mg/L exposure, all rats demonstrated labored breathing, which persisted for up to 1-2 days for males and females, respectively. Also, 2 of 5 male rats demonstrated a high posture that resolved 2 days following the exposure, while 3 females demonstrated a high posture 2 days post-exposure following the 5.6 mg/L exposure. On test day 2 following the 5.6 mg/L exposure, 2 female rats demonstrated lethargy that was resolved by 3 days post-exposure. One day following the 2.2 mg/L exposure, 2 of 5 females demonstrated hypoactivity, which resolved by 3 days post-exposure.
Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for the test substance in male and female rats was greater than 5.6 mg/L.
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