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EC number: 275-639-3 | CAS number: 71566-54-6
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 2021 - July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
- Principles of method if other than guideline:
- 5-day dust inhalation study in rats (with bronchoalveolar lavage, 3 weeks recovery period)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- EC Number:
- 275-639-3
- EC Name:
- Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Cas Number:
- 71566-54-6
- Molecular formula:
- C50 H42 Cl2 N6 O8
- IUPAC Name:
- diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- - State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles: BET = 29.5 +/- 0.3 m2/g
- Coating: none
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH; 97633 Sulzfeld
- Age at study initiation: about 7 weeks (when supplied)
- Weight at study initiation (means):ca 255g
- Housing: The rats were housed together (up to 5 animals per cage) in Polysulfon cages (H-Temp [P SU]) supplied by TECNIPLAST, Hohenpeißenberg, Germany (floor area about 2065 cm2). Bedding in
the Polycarbonate cages were Type Lignocel fibres, dust-free bedding, supplied by SSNIFF, Soest,
Germany. Dust-free wooden bedding was used in this study. For enrichment wooden gnawing blocks
(Typ NGM E-022), supplied by Abedd Lab. and Vet. Service GmbH, Vienna, Austria, were added.
- Diet: Mouse/rat laboratory diet “GLP”, 10 mm pellets (Provimi Kliba SA, Kaiseraugst, Basel Switze rland), ad libitum.
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%) 45 - 65
- Air changes (per hr): 15
Photoperiod (hrs dark / hrs light):: 12h/12h
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- >= 0.51 - <= 0.77 µm
- Geometric standard deviation (GSD):
- 3.5
- Remarks on MMAD:
- The particle size resulted in MMADs between 0.51 and 0.77 µm with GSDs between 2.9 and 3.92 (Table 1). The calculated mass fractions of particles below 3 µm aerodynamic size is greater than 88 %. Thus, the aerosols were highly respirable for rats and a very high proportion of the aerosol particles reached the lungs.
- Details on inhalation exposure:
- For each concentration the dust aerosol was generated with the dust generator and compressed air inside a mixing stage, mixed with conditioned air, and passed via the cyclonic separator and glass tube into the inhalation system
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Generator systems: Solid particle generators (brush-generator), Aerosol mixing tube (Stainless steel), Glass cyclonic separators
- Generation procedure: The test substance was used unchanged. By means of dust generators the substance to be tested is generated into dust aerosols using compressed air in a mixing stage, mixed
with conditioned air and passed into the inhalation systems via cyclonic separators. For each concentration, a solid particle generator (brush-generator) wias used for generating the dust. The con
centration was adjusted by varying the piston feed and by varying the brush rotation. For each concentration the dust aerosol was generated with the dust generator and compressed air inside a mixing stage mixed with conditioned dilution air and passed via the cyclonic separator into the inhalation system. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations of the inhalation atmospheres in test groups 1 - 3 were analyzed by gravimetry. This method was applicable because the test item possessed extremely low vapor pressure. Daily means were calculated based on 3 measured samples per concentration and exposure. From the daily mean values of each concentration, mean concentrations and standard deviations for the entire study were derived.In these groups, the constancy of concentrations in each chamber was continuously monitored using scattered light photometers.
The particle size analysis was carried out with a cascade impactor with the following equipment:
• Stack sampler Marple 298 (New Star Environmental, Inc., Roswell, Georgia 30075, USA)
• Vacuum compressed air pump (Millipore Corporation, Billerica, MA 01821, USA)
• Limiting orifice 3 L/min (Millipore Corporation, Billerica, MA 01821, USA)
• Sampling probe internal diameter 6.9 mm
• Balance Sartorius MSA 6.6S-000-DF (Sartorius AG, Göttingen, Germany)
Sampling for particle size analyses:Pre-weighed metal collecting discs and a backup particle filter were placed into the cascade impactor and two samples were taken in each concentration at a sampling velocity of 1.25 m/sec. from the breathing zones of the animals.
The amount of dust deposited by each stage in mg was calculated from the difference between the weight of the filter/metal collecting disc and backup filter before and after sampling.The deposits in the probe and the wall losses in the impactor were also determined as difference of the total mass increase of the impactor and the sum of masses on the collecting discs and backup filter.
To determine the particle size distribution in the submicrometer range, each test atmosphere was measured with the Scanning Mobility Particle Sizer (SMPS; Grimm Aerosol Technik GmbH& Co KG, Ainring, Germany). The SMPS system comprises an Electrostatic Classifier (Model Vienna U-DMA) which separates the particles into known size fractions, and a Condensation Particle Counter (CPC) which measures particle count concentrations. The DMA was equipped with Am-241 neutralizer. During the exposure period, one measurement per concentration with 10 repeats each were performed.
Real time surveillance of the inhalation atmospheres with scattered light photometers generally proved the constancy of each concentration throughout the daily exposures.
The air flows were constantly maintained in the desired range. An air change of about 65 to 67 times per hour can be calculated by dividing the supply air flow through the volume of each inhalation system. Daily mean relative humidities in the inhalation systems ranged between 33.7 and 49.6 %. Daily mean temperatures in the inhalation systems ranged between 20.6 and 22.1 °C. These values were within guideline recommendations. - Duration of treatment / exposure:
- 6h for 5 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.9 mg/m³ air (analytical)
- Dose / conc.:
- 19.8 mg/m³ air (analytical)
- Dose / conc.:
- 60 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 10 (five for sacrifice after exposure and 5 for sacrifice after recovery)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
Results of short-term inhalation studies with other inert organic pigments
- Rationale for animal assignment: random
- Fasting period before blood sampling for clinical bioche Particlesmistry: overnight
- Rationale for selecting satellite groups: Clearance of inert particles by lung macrophages is known to take time
- Post-exposure recovery period in satellite groups: 3 weeks - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- A check for moribund or dead animals was carried out twice per day on working days. A check for moribund or dead animals was carried out once per day on weekends and holidays.
The clinical observation was performed on each animal at least three times (before, during and after exposure) on exposure days and once a day during pre-exposure and post exposure observation days. On exposure-free weekends and post exposure observation weekends, no clinical observation was performed. Signs and findings were recorded for each animal.During exposure only a group wise examination was possible.
The animals were weighed prior to the pre-exposure period (study day -5), at the start of the exposure period (study day 0), at the end of the exposure period (study day 4), as well as on the study days 5, 12, 19 and 26.
Food consumption was determined once over the exposure period (study day 0 – study day 4), during the post-exposure period weekly and calculated as mean food consumption in grams per animal and day.The animals were maintained in social-housing cages, with 5 animals per cage, during the whole study period. Therefore, the food consumption was determined cage-wise. The food consumption per animal and day was calculated by dividing food consumption of the day of a respective cage by the 5 animals per cage. As the animals of each test group were housed in only two cages per sex, no statistical evaluation of food consumption is possible - Sacrifice and pathology:
- Clinical pathology
In the morning blood was taken from the retro-bulbar venous plexus from fasted animals. The animals were anaesthetized using isoflurane. The blood sampling procedure and subsequent analysis of blood samples were carried out in a randomized sequence (the list of randomization instructions was compiled with a computer).
The assays of blood and serum parameters were performed under internal laboratory quality control conditions with reference controls to assure reliable test results.
The results of clinical pathology examinations were expressed in International System (SI) units. The following parameters of the animals were examined
Clinical chemistry: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase,-Glutamyltransferase, Inorganic phosphate, Calcium, Urea, Creatinine, Glucose, Total bilirubin, Total protein, Albumin, Globulins,Triglycerides,Cholesterol
Bronchoalveolar lavage fluid (BAL): The animals designated for lung lavage were killed by exsanguination from aorta abdominalis and vena cava under Narcoren® anesthesia. The lung was lavaged by two instillations of physiologic saline.
Parameters and methods of cytological examination in BAL: Total cell count, Macrophages, Polymorphonuclear neutrophils, Lymphocytes, Eosinophils, Monocytes, Epithelial, Gamma−Glutamyltransferase, Protein, Lactate dehydrogenase, Alkaline phosphatase, N-acetyl-Beta-Glucosaminidase
Cytokines in BAL: Rat monocyte chemoattractant protein-1 (rat MCP-1), Rat cytokine-induced neutrophil chemoattractant-1 level (rat CINC-1/IL-8), Rodent osteopontin
Necropsy
The animals were sacrificed under pentobarbital anesthesia by exsanguination from the abdominal aorta and vena cava. Afterwards, the thorax was opened, the right lung lobes werelavaged, whereas the left lung lobe was ligated during lavage. Immediately after lung lavage,
the animals were necropsied and assessed by gross pathology.
The following weights were determined in all animals sacrificed on schedule:
1. Anesthetized animals (terminal body weight)
2. Adrenal glands (fixed)
3. Brain
4. Epididymides
5. Heart
6. Kidneys
7. Liver
8. Lungs
9. Spleen
10. Testes
11. Thymus (fixed)
12. Thyroid glands (with parathyroid glands) (fixed)
All paired organs were weighed together (left and right).
The following organs or tissues were fixed in 4% neutral buffered formaldehyde solution:
1. All gross lesions
2. Adrenal glands
3. Bone marrow (femur)
4. Brain with olfactory bulb
5. Epididymides
6. Esophagus
7. Eyes with optic nerve
8. Heart
9. Kidneys
10. Larynx/pharynx
11. Liver
12. Lungs
13. Lymph nodes (tracheobronchial and mediastinal lymph nodes)
14. Nose (nasal cavity)
15. Seminal vesicles
16. Spinal cord (cervical, thoracic and lumbar cord)
17. Spleen
18. Stomach (forestomach and glandular stomach)
19. Testes
20. Thyroid glands
21. Thymus
22. Trachea
23. Urinary bladder
Extend of histological processing and sub-sequent microscopical examinations in main group animals: all gross lesions, larynx (3 level), lungs, lymph nodes (tracheobronchial, mediastinal), nasal cavity (4 levels), trachea and in recovery group animals: all gross lesions, larynx (3 level), lungs, lymph nodes (tracheobronchial, mediastinal) - Other examinations:
- Lung lavage: The animals intended for lung lavage were sacrificed under pentobarbitone anesthesia by exsanguination from the abdominal aorta and vena cava. The right lung was lavaged in situ with physiological saline, whereas the left lung was ligated during this procedure.
- Statistics:
- Body weight, body weight change: Comparison of each group with the control group was performed using DUNNETT test (two-sided) for the hypothesis of equal means
Blood parameters: For parameters with bidirectional changes: Non-parametric one-way analysis using KRUSKAL-WALLIS test. If the resulting pvalue was equal or less than 0.05, a pairwise comparison of each dose group with the control group was performed using WILCOXON-test (two-sided) for the hypothesis of equal medians
For parameters with unidirectional changes: Pairwise comparison of each dose group with the control group using the WILCOXON-test (one-sided) for the hypothesis of equal medians
BALF: Pairwise comparison of each dose group with the control group using the WILCOXON-test (one-sided) for the hypothesis of equal medians
Organ weights: Non-parametric one-way analysis using the Kruskal-Wallis test (two-sided). If the resulting p-value was equal to or less than 0.05, a pair-wise comparison of each dose group with the control group was performed using the Wilcoxon test (two-sided) for the hypothesis of equal medians.
Terminal body weight: Comparison of each group with the control group was performed using the Dunnett test (two-sided) for the hypothesis of equal means.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
Effect levels
open allclose all
- Dose descriptor:
- LOAEC
- Remarks:
- local effects
- Effect level:
- 5 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: min. infiltration of neutrophils within bronchiolar epithelium, hyptrophy/hyperplasia of terminal bronchi (terminal and small), hyperplasia of type II pneumocytes, increased cellularity in the mediastinal lymph nodes. Findings in BALF
- Dose descriptor:
- NOEC
- Remarks:
- systemic effects
- Effect level:
- >= 60 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: only findings in BALF
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 5 mg/m³ air (analytical)
- System:
- respiratory system: upper respiratory tract
- Organ:
- lungs
- Treatment related:
- yes
- Dose response relationship:
- yes
Any other information on results incl. tables
Table 1: Test concentration and particle size distribution
Test group | Target concentration | Measured concentration (mg/m³) | MMAD (µm) | GSD | Fraction of particles | |
(mg/m³) | Mean | SD | < 3 µm [%] | |||
1,00 | 5,00 | 4,90 | 0,70 | 0,51 | 3,92 | 90,30 |
0,62 | 3,67 | 88,80 | ||||
2,00 | 20,00 | 19,80 | 1,30 | 0,58 | 3,41 | 91,00 |
0,77 | 2,90 | 89,60 | ||||
3,00 | 60,00 | 60,00 | 2,90 | 0,67 | 3,49 | 88,50 |
0,59 | 3,67 | 89,40 |
Applicant's summary and conclusion
- Conclusions:
- Inhalation exposure of rats to 60 mg/m³ on 5 consecutive days caused increased total cell count, increased absolute and relative lymphocytes, neutrophils and monocyte counts in bronchoalveolar lavage, while relative macrophage count was reduced in lavage fluid. Moreover, several biochemical parameters (protein concentration, enzyme activities and cytokine concentrations) were significantly increased in lavage fluid. Consistently, minimal infiltration of neutrophils within bronchiolar epithelium was observed, as well as hyptrophy/hyperplasia of terminal bronchi (terminal and small),hyperplasia of type II pneumocytes, increased cellularity in the mediastinal lymph nodes. These findings were also observed at 20 mg/m³ and 5 mg/m³ with reduced severity.
After the post-exposure period of 3 weeks, the effects resolved only partly in the mid and high dose group whereas in the low dose group reversibility was complete.
Under current study conditions, a no observed adverse effect concentration (NOAEC) for local effects could not be determined. The systemic NOAEC is above 60 mg/m³ (high concentration group). - Executive summary:
The following substance-relative adverse findings were observed:
Test group 3 (60 mg/m³), main groups
- Increase of absolute and relative lung weights (+31.1%/+32.3%)
- Macroscopically red discoloration of the lungs in all animals
- Slight alveolar histiocytosis with red particles in the lungs of all animals
- Minimal to slight infiltration of neutrophils in the lungs of all animals
- Minimal to slight cellular debris in the lungs of all animals
- Slight to moderate numbers of particles within bronchi/interstitium in the lungs of all animals
- Moderate to severe hypertrophy/hyperplasia of bronchi (terminal and small) in the lungs of all animals
- Slight hyperplasia of type II pneumocytes in the lungs of all animals
- Minimal to slight increased cellularity in the mediastinal lymph nodes in 4 out of 5 animals
- Increasedtotal protein levels as well asg-glutamyl-transferase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP) and N-acetyl-β-D-glucosaminidase (NAG) activities in BAL
- Increased cytokine-induced neutrophil chemoattractant-1 (CINC-1/IL-8), monocyte chemoattractant protein-1 (MCP-1) and osteopontin levels in BAL
- Increased total cell counts as well as absolute and relative neutrophil, monocyte and eosinophil cell counts in BAL
- Increased absolute lymphocyte and macrophage counts in BAL
- Decreased relative macrophage counts in BAL
Test group 2 (20 mg/m³), main groups
- Increase of absolute and relative lung weights (+12.2%/+18.7%)
- Macroscopically red discoloration of the lungs in all animals
- Slight alveolar histiocytosis with red particles in the lungs of all animals
- Minimal infiltration of neutrophils in the lungs of all animals
- Minimal cellular debris in the lungs of all animals
- Slight numbers of particles within bronchi/interstitium in the lungs of all animals
- Slight to moderate hypertrophy/hyperplasia of bronchi (terminal and small) in the lungs of all animals Minimal to slight hyperplasia of type II pneumocytes in the lungs of all animals
- Minimal to slight hyperplasia of type II pneumocytes in the lungs of all animals
-
Increased total protein levels as well asg-glutamyl-transferase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP) and N-acetyl-β-D-glucosaminidase (NAG) activities in BAL
-
Increased cytokine-induced neutrophil chemoattractant-1 (CINC-1/IL-8), monocyte chemoattractant protein-1 (MCP-1) and osteopontin levels in BAL
-
Increased total cell counts as well as absolute and relative neutrophil and monocyte counts in BAL
-
Increased absolute lymphocyte and eosinophil cell counts in BAL
-
Decreased relative macrophage counts in BAL
Test group 1 (5 mg/m³), main groups
- Macroscopically red discoloration of the lungs in all animals
- Minimal alveolar histiocytosis with red particles in the lungs of all animals
- Minimal infiltration of neutrophils in the lungs of 4 out of 5 animals
- Minimal numbers of particles within bronchi/interstitium in the lungs of all animals
- Minimal to slight hypertrophy/hyperplasia of bronchi (terminal and small) in the lungs of all animals
-
Increasedtotal protein levels as well asg-glutamyl-transferase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP) and N-acetyl-β-D-glucosaminidase (NAG) activities in BAL
-
Increased cytokine-induced neutrophil chemoattractant-1 (CINC-1/IL-8), monocyte chemoattractant protein-1 (MCP-1) and osteopontin levels in BAL
-
Increased total cell counts as well as absolute and relative neutrophil and monocyte counts in BAL
- Increased absolute lymphocyte and eosinophil cell counts in BAL
- Decreased relative macrophage counts in BAL
Test group 3 (60 mg/m³) after 3 weeks post-exposure observation period
- Macroscopically red discoloration of the lungs in all animals
- Slight alveolar histiocytosis with red particles in the lungs of all animals
- Minimal infiltration of neutrophils in the lungs of 2 out of 5 animals
- Slight numbers of particles within bronchi/interstitium in the lungs of all animals
- Minimal hypertrophy/hyperplasia of bronchi (terminal and small) in the lungs of 3 out of 5 animals
- Minimal to slight hyperplasia of type II pneumocytes in the lungs of all animals
- Minimal to slight increased cellularity in the mediastinal lymph nodes in 4 out of 5 animals
-
Increased lactate dehydrogenase (LDH) activities in BAL
-
Increased cytokine-induced neutrophil chemoattractant-1 (CINC-1/IL-8), monocyte chemoattractant protein-1 (MCP-1) and osteopontin levels in BAL
-
Increased total cell counts as well as absolute lymphocyte, neutrophil and monocyte counts in BAL
-
Increased relative neutrophil cell counts in BAL
-
Decreased relative macrophage counts in BAL
Test group 2 (20 mg/m³) after 3 weeks post-exposure observation period
-
Increased lactate dehydrogenase (LDH) activities in BAL
- Increased cytokine-induced neutrophil chemoattractant-1 (CINC-1/IL-8), monocyte chemoattractant protein-1 (MCP-1) and osteopontin levels in BAL
- Increased total cell counts as well as absolute neutrophil and monocyte counts in BAL
Test group 1 (5 mg/m³) after 3 weeks post-exposure observation period
No treatment-related, adverse effects
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