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EC number: 201-579-4 | CAS number: 85-00-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Aug 1985 to 05 Sep 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- 1998
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 1992 + amendment 93/21/EEC (1993).
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- Diquat dibromide
- EC Number:
- 201-579-4
- EC Name:
- Diquat dibromide
- Cas Number:
- 85-00-7
- Molecular formula:
- C12H12N2.2Br
- IUPAC Name:
- 1,1'-ethylene 2,2'-bipyridyldiylium dibromide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult; 65-90 days (males), 66-91 days (females)
- Weight at study initiation: 313- 493 g (males); 197-314 g (females)
- Housing: Individually in wire-bottomed cages
- Diet: Purina Laboratory Rodent Chow #5001 ad libitum except during exposure.
- Water: mains water ad libitum except during exposure.
- Acclimation period: 21 - 46 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 22.6
- Humidity (%): 63 - 73
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 01 Aug 1985 To: 05 Sep 1985
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- water
- Mass median aerodynamic diameter (MMAD):
- >= 2.15 - <= 2.82 µm
- Geometric standard deviation (GSD):
- >= 1.95 - <= 2.05
- Remark on MMAD/GSD:
- Approximately 97 - 99 % of each aerosol was smaller than 10 microns
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Animals were exposed to aerosols of diluted test material. The generator solution was made by diluting 100 mL test substance to 1 L with distilled water. The test aerosols were generated using a nebuliser which pulled generator solution from a continuously stirred 1 L reservoir and unaerosolized material fromt he nebulizer drained back into the reservoir. Room air was drawn through the nebuliser to sweep the aerosol into the inlet at the top of the chamber at average flow rates of 4.6, 7.2 and 11.0 L/min, for the 0.15, 1.0 and 4.0 mg/L target concentrations, respectively. The nebuliser was operated at a pressure of 20 psi for the 2 lower target concentrations, and at 30 psi for the 4.0 mg/L concentration.
The exposure chambers were stainless steel, 27-inch, cubical chambers with pyramidal tops and bottoms and an internal volume of approximately 0.42 m3. The test and control rats were placed in 10 of 16 individual wire cages on one level within their respective chambers. Chamber pressure was maintained negative relative to the laboratory and the total flows through the test and control chambers were approximately 106 L/min. Exhaust from the bottom of each chambers passed through HEPA filters, a calibrated flow monitor and another filter train before discharge to the atmosphere. Control animals were exposed to filtered air only and were exposed concurrently with the 0.15 mg/L target exposure group. Chamber temperature, relative humidity and air flows were recorded initially and then every 30 minutes during exposure using an electronic thermometer, dial hygrometer and calibrated flow monitor, respectively.
TEST ATMOSPHERE
The total aerosol concentration of the test atmosphere, close to the animals’ breathing zone, was measured gravimetrically every 30 minutes during the exposure period. This was done by drawing the test atmosphere, at a known flow rate, for a known time, through a 25 mm diameter, Whatman GF/A filter housed in an open-faced filter holder. The amount of total aerosol was estimated gravimetrically for the 1.0 and 4.0 mg/L target exposures and with a Real-Time Aerosol monitor (GCA/Environmental Instruments) for the 0.15 mg/L target exposure. All filter samples were analysed for substance.
VEHICLE
The sample was tested as aerosols of test material diluted with distilled water. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- - Target concentrations: 0.15, 1.0, 4.0 mg/L
- Nominal concentrations: 0.16, 1.13, 3.86 mg/L - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Remarks:
- filtered air
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: following exposure, animals were observed twice daily, except at weekends when they observed once daily, during a 14-day observation period. The body weight of each rat was recorded before exposure and on days 2, 7 and 14 days following exposure.
- Necropsy of survivors performed: yes, external observation and examination of skin, spleen, pancreas, oesophagus, stomach, small and large intestine, liver, adrenals, kidneys, reproductive organs, bladder, heart, thymus, salivary glands, lungs, trachea, thyroid, brain, eyes and fat. Skulls, kidneys and a portion of liver were preserved in 10% neutral buffered formalin for possible future histological examination. Lungs were infused via the trachea, preserved in 10 % neutral buffered formalin and submitted for histopathological evaluation. Tissues were routinely processed, stained with haematoxylin and eosin and examined by light microscopy. - Statistics:
- The LC50, slope and 95 % confidence limits were determined from the mortality data.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.121 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.018 - <= 0.793
- Exp. duration:
- 4 h
- Remarks on result:
- other: Original value presented in study
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 0.132 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.022 - <= 0.781
- Exp. duration:
- 4 h
- Remarks on result:
- other: Original value presented in study
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.125 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.041 - <= 0.377
- Exp. duration:
- 4 h
- Remarks on result:
- other: Original value presented in study
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 0.226 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.034 - <= 1.481
- Exp. duration:
- 4 h
- Remarks on result:
- other: Recalculated value, expressed as pure substance, see ‘Any other information on results incl. tables’ for respective calculation
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 0.247 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.041 - <= 1.459
- Exp. duration:
- 4 h
- Remarks on result:
- other: Recalculated value, expressed as pure substance, see ‘Any other information on results incl. tables’ for respective calculation
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.234 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 0.077 - <= 0.704
- Exp. duration:
- 4 h
- Remarks on result:
- other: Recalculated value, expressed as pure substance, see ‘Any other information on results incl. tables’ for respective calculation
- Mortality:
- All animals exposed to 3.86 mg/L died 2-10 days after exposure. Three males and 2 females exposed to 1.13 mg/L died 3 - 5 days after exposure. There were no deaths in animals exposed to 0.16 mg/L.
- Clinical signs:
- other: See "Other findings: Other observations"
- Body weight:
- No statistical comparisons were made due to mortality and the different start dates of the exposures. Group mean body weights showed a weight loss in all exposed groups on day 2 after exposure (compared to day 0 before exposure). At the mid and high exposure levels, a continued weight loss was seen on day 7 but there was some weight gain by day 14 in males and females exposed to 1.13 mg/L.
- Gross pathology:
- At necropsy, lesions were seen in the lungs of all animals exposed to 3.9 mg/L and most of those at 1.13 mg/L. These lesions included reddening, darkening, oedema, mottling, and consolidations of the lung. In two males of the 3.86 mg/L group, yellow fluid was found in the trachea. No gross lesions were observed in the control and 0.16 mg/L dose groups.
- Other findings:
- HISTOPATHOLOGY
Histological examination of lungs revealed compound-related changes at all exposure levels, generally increasing in severity with increasing exposure concentration. All of the rats in the 1.13 mg/L and 3.86 mg/L groups had moderate to severe microscopic changes comprising subchronic inflammatory lesions; pulmonary congestion and oedema; and alveolar/septal thickening. Subchronic inflammation and/or alveolar/septal thickening were seen in three males and two females in the 0.16 mg/L group, but were of lower severity.
OTHER OBSERVATIONS
Squinted eyes and salivation were seen in exposed animas during exposure. Laboured breathing, abnormal respiratory sounds, increased respiratory rate, red oral /nasal /ocular discharge, reduced food intake and/or reduced faeces were seen following exposure. In rats exposed to 1.13 mg/L, there were also signs of slight hindquarter ataxia (2 males only), weakness (1 female only), unkempt appearance and sores or alopecia on the throat (seen in 2 males and 3 females between 6 - 9 days post exposure). At 0.16 mg/L, squinted eyes were present during exposure and salivation, red nasal and/or oral discharge, reduced faeces and unkempt appearance was present after exposure. Sores /alopecia on the throat was seen in 1 female 13 days post exposure but surviving animals appeared otherwise normal by 6 days post exposure.
Any other information on results incl. tables
Table 1: Mortality / animals treated
Group Number (5 rats/sex) |
Dose level (mg/L) |
Day of death |
Number of deaths |
|
Male |
Female |
|||
1 |
0 |
Total at day 14 |
0/5 |
0/5 |
2 |
0.16 |
Total at day 14 |
0/5 |
0/5 |
3 |
1.13 |
3 |
2 |
0 |
|
|
4 |
0 |
1 |
|
|
5 |
1 |
1 |
|
|
Total at day 14 |
3/5 |
2/5 |
4 |
3.86 |
2 |
1 |
0 |
|
|
3 |
2 |
0 |
|
|
4 |
1 |
0 |
|
|
7 |
0 |
1 |
|
|
8 |
0 |
2 |
|
|
9 |
0 |
2 |
|
|
10 |
1 |
0 |
|
|
Total at day 14 |
5/5 |
5/5 |
Table 2: Characteristic of test substance Atmospheres
Target Total Aerosol Concentration (mg/L) |
Achieved Total Aerosol Concentration (mg/L) |
Analysed test substance Concentration (µg/L) |
MMAD(a)mm |
GSD(b) |
0 |
0 |
|
- |
- |
0.15 |
0.16 |
86.1 |
2.81, 2.82 |
1.98, 1.99 |
1.0 |
1.13 |
118 |
2.15, 2.21 |
2.01, 1.99 |
4.0 |
3.86 |
211 |
2.48, 2.44 |
1.96, 2.05 |
(a) Mass Median Aerodynamic Diameter(mm)
(b) Geometric Standard Deviation
Calculation of key result
The original effect levels were expressed as cation species of the registered substance. The key effect levels are re-calculated and corrected to include the counterion species by multiplying with 1.868 (344.0 g/mol molecular weight of registered substance divided by 184.2 g/mol molecular weight of cation species):
The acute inhalation LC50 for male rats = 1.868 x 121 = 226 μg/L
The acute inhalation LC50 for male rats =1.868 x 132 = 247 μg/L
The acute inhalation LC50 for both sexes combined in rats = 1.868 x 125 = 234 μg/L
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- The acute inhalation LC50 of test substance ion was 0.121 mg/L for males, 0.132 mg/L for females and 0.125 mg/L for both sexes combined. This is equivalent to an acute inhalation LC50 of 0.226 mg/L for males, 0.247 mg/L for females and 0.234 mg/L for both sexes combined of the test substance salt.
- Executive summary:
In a GLP compliant acute inhalation toxicity study, comparable to OECD TG 403, groups of young adult Sprague-Dawley CD rats (5/sex/dose) were exposed by inhalation (whole body) for 4 hours, to aerosols of test substance in form of a technical concentrate (equivalent to 19.5 %w/w test substance ion), in distilled water, to target total aerosol concentrations of 0 (controls), 0.15, 1.0 or 4.0 mg/L. The amount of total aerosol was determined gravimetrically and all filter samples were analysed for test substance. The particle size distribution of the test atmosphere was analysed twice during the exposure period. After an observation period of 14 days after animals were necropsied. Specified tissues were submitted for histological examination. The average total aerosol concentrations were determined to be 0.16, 1.13 and 3.86 mg/L. The average mass median aerodynamic diameter (MMAD) of the aerosol ranged from 2.15 to 2.82 μm. Test substance ion concentrations for the exposures were determined to be 86.1 μg/L, 118 µg/L and 211 μg/L. The GSD (Geometric Standard Deviation) ranged from 1.99 to 2.05. Approximately 97 - 99 % of each aerosol was smaller than 10 microns.
Whole-body exposure for 4 hours to aerosols of diluted test substance, at average total aerosol concentrations of 0, 0.16, 1.13 or 3.86 mg/L, resulted in mortalities at 1.13 and 3.86 mg/L. All animals exposed to 3.86 mg/L died 2-10 days after exposure. Three males and 3 females exposed to 1.13 mg/L died 3 - 5 days after exposure. There were no deaths in animals exposed to 0.16 mg/L. Signs of toxicity included: squinted eyes and salivation (seen during exposure at all concentrations); laboured breathing, increased respiration rate, abnormal respiratory sounds; nasal, oral and/or ocular discharge; slight hindquarter ataxia / weakness; sores/alopecia on the throat; weight loss. At necropsy, treatment related lung changes were present in animals exposed to 1.13 and 3.86 mg/L. Histopathological examination revealed exposure-related, subchronic inflammation, congestion, oedema and alveolar/ septal thickening in the lungs of all rats exposed to 1.13 and 3.86 mg/L. Three males and two females in the 0.16 mg/L group had subchronic inflammation and alveolar / septal thickening of the lungs.
It is concluded that the acute inhalation LC50 of test substance was 0.80 mg/L for males, 1.09 mg/L for females and 0.97 mg/L for both sexed combined. This was equivalent to the following LC50 for the test substance ion: 0.121 mg/L for males, 0.132 mg/L for females and 0.125 mg/L for both sexes combined. And this is equivalent to an acute inhalation LC50 of 0.226 mg/L for males, 0.247 mg/L for females and 0.234 mg/L for both sexes combined of the test substance salt.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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