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EC number: 236-291-8 | CAS number: 13282-70-7
- 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:
- From 2015-03-09 To 2015-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
- EC Number:
- 236-291-8
- EC Name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
- Cas Number:
- 13282-70-7
- Molecular formula:
- C23H48N2O.C2H4O2
- IUPAC Name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- CRL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable): n/a
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Rationale for use of males (if applicable):n/a
- Age at study initiation: 7 weeks old.
- Weight at study initiation: Male between 371 and 395 grams; Females 231 and 268 grams at the time of exposure.
- Fasting period before study:n/a
- Housing:housed individually in solid bottom caging with bedding and enrichment.
- Historical data:n/a
- Diet (e.g. ad libitum): PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum.
- Water (e.g. ad libitum):tap water were available ad libitum.
- Acclimation period:6 days prior testing.
- Microbiological status when known: Water samples are analyzed for total bacterial counts, and the presence of coliforms, lead, and other contaminants. Samples from freshly washed cages and cage racks are analyzed to ensure adequate sanitation by the cagewashers.
- Method of randomisation in assigning animals to test and control groups: n/a
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 30-70%
- Air changes (per hr): 28 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.
IN-LIFE DATES: From: 9 March 2015 To: 23 March 2015
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- water
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:Spraying Systems Company® nebulizer
- Exposure chamber volume: 34 L.
- Method of holding animals in test chamber: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.
- Source and rate of air (airflow):
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:
TEST ATMOSPHERE
- Brief description of analytical method and equipment used: The test substance was metered into the nebulizer with a Cole-Palmer Masterflex® console drive pump. High-pressure air, metered into the nebulizer by a Brooks model 5850E mass flow controller, carried the resulting atmosphere into the exposure chamber. Chamber concentrations of test substance were controlled by varying the test substance feed rate to the nebulizer.
The test atmosphere was exhausted through a high-capacity particle filter cartridge prior to discharge into the fume hood.
- Samples taken from breathing zone: yes
- Time needed for equilibrium of exposure concentration before animal exposure:
VEHICLE
- Composition of vehicle (if applicable): test material diluted 10 times by volume within distilled water.
- Concentration of test material in vehicle (if applicable): 5 mg/L
- Justification of choice of vehicle: n/a
- Lot/batch no. (if required): n/a
- Purity: n/a
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:Samples to determine aerosol size distribution (mass median aerodynamic diameter, geometric standard deviation, and percent percent aerosols less than 1, 3, and 10 μm diameter.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMAD (GSD) were 4.1 μm (2.5), 3.0 μm (2.5), and 3.9 μm (2.4) which are regarded as respirable.
- Duration of exposure:
- 4 h
- Concentrations:
- maximum practically-attainable atmospheric concentration of 4.0 ± 0.30 mg/L (diluted)
- No. of animals per sex per dose:
- one group of 5 male and 5 female (nulliparous and non-pregnant)
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Clinical signs including body weight : yes.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- Upon completion of the exposures, CITADS sample results were transferred to the Camile Inhalation Reporting and Analysis System (CIRAS), which collated sample calculations.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 mg/L air
- Based on:
- test mat. (dissolved fraction)
- Remarks:
- diluted
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All animals survived the 4-hour exposure to 4.0 mg/L (diluted) H-31339 but 2 (of 5) male rats and 1 female rat died during the 14-day recovery period. The fractional mortalities were 2/5 for male rats and 1/5 for female rats.
- Clinical signs:
- bodyweight loss
- Body weight:
- - greater than 10% body weight loss: n/a
- lower than 10% body weight loss:maximum lost 13% .
- other body weight observations:
Five (of 5) male rats lost 6.6-13% of their body weights on test day 2. One male was later found dead on the same day and another male was found dead on day 3. One of the 3 surviving males lost 7.7 and 1.7% of his body weight on test day 3 and 4, respectively. Three (of 5) female rats lost 12-13 % of their body weights on test day 2 and one of them was later found dead on the same day. Two of the 4 surviving females lost <7% of their body weights on test day 3 and only 1 female lost 4.1% on test day 4. The weight variation in animals used on an exposure did not exceed ± 20% of the mean weight of each sex.
All other animals gain weights and no abnormalities were detected during the rest of the 14-day recovery period. - Gross pathology:
- Gross findings were present in 3 male and 4 female rats administered 4.0 mg/L of diluted test substance: 2 found dead males, 1 found dead female and the remainder at scheduled sacrifice. Five of these animals (2 males and 3 females) had multifocal to diffuse dark discoloration of the lung, often concentrating in the cranial portion of the lung. One found dead male additionally had expanded lungs and cloudy discoloration of the left eye. The two found dead males had red staining on their faces, and the found dead female had thick, tan discoloration in the trachea. The observations are presumed related to test substance exposure. No other gross findings were observed.
Any other information on results incl. tables
Mortality
Sex | Mean Atmospheric Concentration (mg/L) | Mortality (deaths/exposed) |
Male | 4.0 | 2/5 |
Female | 4.0 | 1/5 |
Summary of Clinical Observations and Mortality in Male Rats
Found dead |
| |
Number of Observations | 2 | |
Number of Animals | 2 | |
Days from – to | 2 3 | |
Scheduled sacrifice |
| |
Number of Observations | 3 | |
Number of Animals | 3 | |
Days from – to | 15 15 | |
Breathing - laboured | ||
Number of Observations | 8 | |
Number of Animals | 3 | |
Days from – to | 1 4 | |
Breathing – lung noise | ||
Number of Observations | 3 | |
Number of Animals | 1 | |
Days from – to | 2 4 | |
Breathing - slow | ||
Number of Observations | 1 | |
Number of Animals | 1 | |
Days from – to | 2 2 | |
Discharge - red | ||
Number of Observations | 10 | |
Number of Animals | 5 | |
Days from – to | 1 4 | |
Gasping | ||
Number of Observations | 6 | |
Number of Animals | 3 | |
Days from – to | 1 4 | |
Discoloured fur - yellow | ||
Number of Observations | 1 | |
Number of Animals | 1 | |
Days from – to | 2 2 |
Summary of Clinical Observations and Mortality in Female Rats
Found dead |
| |
Number of Observations | 1 | |
Number of Animals | 1 | |
Days from – to | 2 2 | |
Scheduled sacrifice |
| |
Number of Observations | 4 | |
Number of Animals | 4 | |
Days from – to | 15 15 | |
Breathing – laboured | ||
Number of Observations | 7 | |
Number of Animals | 3 | |
Days from – to | 1 4 | |
Breathing – lung noise | ||
Number of Observations | 1 | |
Number of Animals | 1 | |
Days from – to | 4 4 | |
Discharge - red | ||
Number of Observations | 9 | |
Number of Animals | 5 | |
Days from – to | 1 4 | |
Gasping | ||
Number of Observations | 7 | |
Number of Animals | 3 | |
Days from – to | 1 4 | |
Discoloured fur – yellow | ||
Number of Observations | 5 | |
Number of Animals | 2 | |
Days from – to | 2 4 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- While an exposure atmosphere of ≥ 5 mg/L could not be obtained due to the waxy property of the test substance, 4.0 mg/L H-31339 was the highest feasible airborne concentration that could be achieved and required a 10X dilution of the test substance with distilled water.
Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for (diluted) H-31339 in male and female rats was > 4.0 mg/L, the maximum practically-attainable atmopheric concentration, and > 0.66 mg/L solids aerosol concentration. - Executive summary:
The objective of this study was to evaluate the acute inhalation toxicity of H-31339 when administered as an aerosol for a single, 4-hour, nose-only exposure to one group of 5 male and
5 female (nulliparous and non-pregnant) Crl:CD(SD) rats. H-31339 used for this study was a white solid with a purity of 96% by analysis. Due to the waxy property, the test substance was diluted 10 times (by volume) with distilled water to facilitate the generation of an aerosol exposure atmosphere. The test atmosphere was generated by aerosolization of H-31339 in air using a nebulizer and the airborne concentration of H-31339 was determined by gravimetric analysis. During a 14-day recovery period, all animals were weighed and observed for mortality and clinical signs of toxicity. A gross pathological examination was performed on all animals at the scheduled necropsy or shortly after they were found dead.During the exposure, rats were exposed to a maximum practically-attainable atmospheric concentration of 4.0 ± 0.30 mg/L (diluted) H-31339 (mean ± standard deviation) as determined by gravimetric analysis of wet filters. The solids aerosol concentration of the same atmosphere, determined by desiccated filter weights, was 0.66 ± 0.030 mg/L. The mass median aerodynamic diameter and geometric standard deviation, MMAD (GSD), was determined 3 times for the atmosphere and measured 4.1 μm (2.5), 3.0 μm (2.5), and 3.9 μm (2.4).
All animals survived the 4-hour exposure to 4.0 mg/L (diluted) H-31339 but 2 (of 5) male rats and 1 female rat died during the 14-day recovery period. The fractional mortalities were 2/5 for male rats and 1/5 for female rats.
All animals displayed normal startle response during the exposure (test day 1), and no abnormalities were observed. Clinical signs of toxicities including labored breathing, slow breathing, lung noise, gasping, and/or discolored fur were observed in 3 male and 4 female rats during test days 1-4. Five (of 5) male rats lost 6.6-13% of their body weights on test day 2. One male was later found dead on the same day and another male was found dead on day 3. One of the 3 surviving males lost 7.7 and 1.7% of his body weight on test day 3 and 4, respectively. Three (of 5) female rats lost 12-13 % of their body weights on test day 2 and one of them was later found dead on the same day. Two of the 4 surviving females lost <7% of their body weights on test day 3 and only 1 female lost 4.1% on test day 4. All other animals gain weights and no abnormalities were detected during the rest of the 14-day recovery period.
Gross findings were present in 3 male and 4 female rats administered 4.0 mg/L of diluted test substance: 2 found dead males, 1 found dead female and the remainder at scheduled sacrifice. Five of these animals (2 males and 3 females) had multifocal to diffuse dark discoloration of the lung, often concentrating in the cranial portion of the lung. One found dead male additionally had expanded lungs and cloudy discoloration of the left eye. The two found dead males had red staining on their faces, and the found dead female had thick, tan discoloration in the trachea. The observations are presumed related to test substance exposure. No other gross findings were observed.
While an exposure atmosphere of ≥ 5 mg/L could not be obtained due to the waxy property of the test substance, 4.0 mg/L H-31339 was the highest feasible airborne concentration that could be achieved and required a 10X dilution of the test substance with distilled water.
Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for (diluted) H-31339 in male and female rats was > 4.0 mg/L, the maximum practically-attainable atmopheric concentration, and > 0.66 mg/L solids aerosol concentration.
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