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EC number: 223-055-4 | CAS number: 3710-84-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N-diethylhydroxylamine
- EC Number:
- 223-055-4
- EC Name:
- N,N-diethylhydroxylamine
- Cas Number:
- 3710-84-7
- Molecular formula:
- C4H11NO
- IUPAC Name:
- N,N-diethylhydroxylamine
- Details on test material:
- - Name of test material (as cited in study report): Diethylhydroxylamine
- Analytical purity: 96.5%
- Lot/batch No.: 2697 (12/6/84)
- Expiration date of the lot/batch: March 1985
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: Charles River Breeding Laboratories, Inc. Wilmington, Massachusetts 01887
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 228-299 g for males, 170-228 g for females
- Fasting period before study: not appropriate
- Housing: doubly-housed in suspended stainless steel wire mesh cages during the first week of the acclimation period and individually during the remainder of the acclimation period and all other non-exposure periods.
- Diet (ad libitum): standard laboratory diet (Purine Rodent Laboratory Chow #5001 or 5002)
- Water (ad libitum): by automated watering system (Elizabethtown Water Company).
- Acclimation period: 2-3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature : 67-76°F
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- A series of four-hour whole-body inhalation exposures was performed using Sprague-Dawley derived rats (5/sex/group) to determine the acute inhalation toxicity of diethylhydroxylamine. The test substance was administered into the breathing zone of the animals as vapor. In addition, a group of control animals (5/sex) received house-supply air only while in chamber.
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The Plexiglas® exposure chamber had a total volume of 100 liters. The chamber was operated dynamically at a calibrated air flow rate of 25 liters per minute (lpm). This flow rate was calculated to provide one complete air change every 4 minutes and a 99% equilibrium time of 18.4 minutes.
- System of generating particulates/aerosols: The test substance was placed in 500 ml bubblers and fitted with impingers. House-supply air was delivered via a Dwyer flowmeter and a Nupro metering valve, to a set of bubblers then into a 3-neck flask containing glass wool. For Group I, II, V, and VI, bubblers were immersed in a waterbath as provided by a Braun Thermomix. For Groups I, II, III, V and VI, additional diluted air was delivered to the 3-neck flask via a Nupro metering valve and a Dwyer flowmeter. For ail groups, the resultant vapor-laden air stream was directed from the 3-neck flask into the 100 liter Plexiglas® exposure chamber. The initial generation airflow rate, dilution airflow rate, total airflow rate, and waterbath temperature settings are summarized as follows:
Group Generation Dilution Total Water-
Airflow bath
Rate Temp.
Airflow Airflow
Rate Rate
I (1pm) (1pm) (1pm) (°C)
7.0 18.0 25.0 60
II 12.5 12.5 25.0 60
III 14.0 11.0 25.0 -
IV 0 25.0 25.0 -
V 12.5 12.5 25.0 40
VI 12.5 12.5 25.0 37
- Method of particle size determination: Samples for particle size distribution assessment of the chamber and room air were drawn once during the first hour. The chamber particle count for all groups was less than five times the background (room air) using the widest channel therefore the aerosol concentration was considered to be negligible and no further measurements were taken for that exposure. Measurements were performed using a Royco Model 227 Portable Particle Monitor. Particle size distribution measurements were not performed for the control group (Group IV).
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:
TEST ATMOSPHERE
- Brief description of analytical method used: Samples for determination of diethylhydroxylamine exposure levels were taken using a MIRAN® lA Amblent Air Analyzer and strip chart recorder. The test atmosphere was drawn through 1/4" Teflon® line at a flow rate of 2.0 liters per minute (lpm) for Groups II, III, V and VI, and at a maximum attainable flow for Groups I and IV (control) by a Dwyer flowmeter and a Nupro metering valve to a glass "Y" tube where, for Groups II, III, V and VI, it was diluted (2:1) with room air. For Groups I and IV, the samples were assayed undiluted. These samples were drawn into the MIRAN® using a Neptune 4K Dyna-pump, once every half-hour during exposure from the normal sampling portal (denoted H-1 in Figures 1-3). In addition, a distribution sample was drawn once from the distribution sampling portal.
The exposure levels of diethylhydroxylamine were determined by comparison of the resultant absorbance to a calibrated response.
- Samples taken from breathing zone: yes/no
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: No aerosol was found during any exposure. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1410, 2650, 3240, 3560, 4720 ppm (analytical)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - In-Life Observations:
Day 1 (Day of Exposure): All animais were observed individually, immediately prior to exposure, as a group at approximately fifteen minute intervals during the first hour of exposure, at half-hour intervals for hours 1 and 2 and hourly for the remainder of the exposure period. All survivors were observed individually upon removal from the chamber (half hour after exposure was completed) and four hours post-exposure. Detailed physical observations were recorded at each interval.
Days 2 through 15 (Post-exposure): Detailed observations were recorded for survivors once daily; viability was assessed twice daily.
- Body weight:
Day 1 (immediately prior to exposure) and on Days 2, 3, 4, 8, 11 and 15 (just prior to sacrifice).
- Postmortem:
A complete gross postmortem examination was performed on all animals dying spontaneously during the course of the study as well as those animais surviving to the end of the 14-day post-exposure observation period. The gross postmortem examinations included examination of the nasal passages, trachea, external surface, all orifices, the cranial cavity, carcass, the brain and spinal cord, the thoracic, abdominal and pelvic cavities and their viscera and the cervical tissues and organs.
- Terminal Necropsy:
Post-exposure Day 15. - Statistics:
- A calculation of median lethal concentration and 95% confidence limits was performed according to the method of "Litchfield and Wilcoxon''.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 3 140 other: ppm (analytical)
- 95% CL:
- 2 770 - 3 560
- Exp. duration:
- 4 h
- Remarks on result:
- other: LC50 = 11.4 mg/l
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 4 400 other: ppm (analytical)
- 95% CL:
- 3 410 - 5 880
- Exp. duration:
- 4 h
- Remarks on result:
- other: LC50 = 16.0 mg/l
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 2 620 other: ppm (analytical)
- 95% CL:
- 2 210 - 3 100
- Exp. duration:
- 4 h
- Remarks on result:
- other: LC50 = 9.5 mg/l
- Mortality:
- See below
- Clinical signs:
- other: 1. Exposure Period: Lacrimation, irregular breathing, reduced activity, hunched appearance, matted coat, eyes partially closed, dried red material around the facial area and/or chromodacryorrhea were observed during exposure. These occurred in many, but
- Body weight:
- Mean body weights were decreased for both sexes in all test groups compared to control animals on the first day following exposure, and the differences from the control animals seemed to follow a pattern related to exposure concentration. Subsequently, body weight results for all animals except Group V males were considered unremarkable. Group V males had returned to a normal rate of weight gain by the end of the first week post-exposure. Test Week 2 results were considered unremarkable.
- Gross pathology:
- Numerous tissues and organs of the animals which died during the study were discolored, primarily various intensities of red. This was not considered to be unusual in animals which died and were not exsanguinated prior to postmortem examination. The lungs of numerous animals, both treated and control, were discolored; primarily scattered red-grey foci were observed in the animals which were killed at the end of the study, whereas in the animals which died, the lungs were bright to dark red. The toxicologic significance of these findings, if any, could not be determined on the basis of a gross examination on only. Other postmortem findings which were observed grossly occurred sproradically in the treated and/or control animals and did not appear to be related to the test article.
Any other information on results incl. tables
Chamber Monitoring and Mortality:
The mean analytical and nominal concentrations of
diethylhydroxylamine along with the overall mortality in
each test group are summarized below:
-----------------------------------------------------------
Mean
Analytical Nominal Mortality
Group Concentration Concentration #dead/#exposed
(ppm) (ppm) Male Female
-----------------------------------------------------------
I 1410 1690 0/5 0/5
II 4720 5890 5/5 5/5
III 2650 2780 0/5 0/5
IV-Control 0 0 0/5 0/5
V 3560 4430 1/5 5/5
VI 3240 4840 1/5 5/5
----------------------------------------------------------
The individual analytical values showed little variation
about the mean. For Groups I and III, the nominal and analytical
values were approximately the same. For the other
three test groups which were run at higher exposure levels,
the nominal concentrations were somewhat higher than the
analytical values. No reason for these differences between
nominal and analytical values was found. No aerosol was
found during any exposure.
Chamber relative humidity was generally acceptable in all
exposures. Chamber temperature was a few degrees above the
generally acceptable environmental limit (for 24-hour
housing) of 76°F. This environmental condition is considered
to have no effect, upon the conclusion that may be drawn from
the study .
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- A series of groups consisting of five male and five female Sprague-Dawley derived rats was exposed to diethylhydroxylamine vapor for four hours mean analytical levels in the range of 1410 to 4720 parts per million (ppm). Signs attributable to treatment included death, increased incidences of secretory responses, respiratory distress, general signs of poor condition, corneal opacity and loss of body weight. Overall, the time-to-onset and time-to-recovery of these signs were related to exposure concentration. The mortality results indicated the test material was more lethal to female rats than to male rats. The lungs of numerous animals, both treated and control, were discolored primarily scattered red-grey foci were observed in the animals which were killed at the end of the study, whereas in the animals which died, the lungs were bright to dark red. The toxicologic significance of these findings, if any, cannot be determined on the basis of a gross examination only.
- Executive summary:
In an acute inhalation toxicity study performed according to the US EPA guideline, series of groups consisting of five male and five female Sprague-Dawley derived rats was exposed to diethylhydroxylamine vapor for four hours mean analytical levels in the range of 1410 to 4720 parts per million (ppm). At 1410 and 2650 ppm, no rat died, 3240 and 3560 ppm, 1/5 male and 5/5 female rats died, and at 4720 ppm, all rats died. The mortality results indicated the test material was more lethal to female rats than to male rats. Signs attributable to treatment included death, increased incidences of secretory responses, respiratory distress, general signs of poor condition, corneal opacity and loss of body weight. Overall, the time-to-onset and time-to-recovery of these signs were related to exposure concentration. The lungs of numerous animals, both treated and control, were discoloured primarily scattered red-grey foci were observed in the animals which were killed at the end of the study, whereas in the animals which died, the lungs were bright to dark red. The toxicologic significance of these findings, if any, cannot be determined on the basis of a gross examination only. The LC50 was determined 4400 ppm for the males, 2620 ppm for the females and 3140 ppm for both sexes combined.
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