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EC number: 203-940-1 | CAS number: 112-15-2
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Lack of test material details and raw data on clinical chemistry.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- lack of test material details and raw data on clinical chemistry.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethyl acetate
- EC Number:
- 203-940-1
- EC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Cas Number:
- 112-15-2
- Molecular formula:
- C8H16O4
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethanol, 2- (2-Ethoxyethoxy)-, acetate
- Analytical purity: no data
- Other: in the report it is also stated, that a combination aerosol was tested, whoever the combination is not named as the study report is sanitized.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: The animals were housed continously in groups of 2-5 animals in Hazelton H-1000 exposure chambers.
- Diet: was removed during exposure
- Water: was removed during exposure
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazelton H-1000 exposure chamber
- Method of holding animals in test chamber: whole body exposure
- System of generating aerosols: Laskin nebulizers in each chamber were immersed in water bath at approximately 180 °F (82.2 °C) during each exposure to simulate the temperature under normal conditions of use. The output of the nebulizer went through a glass impactor to remove the larger particles before being diluted by the main air stream entering the exposure chamber.
- Temperature, humidity, pressure in air chamber: recorded every 30 min during exposure; 24.6 °C (mean), 66.5% (mean)
- Air change rate: 12
- Method of particle size determination: at least once daily with a cascade impactor. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Nominal concentration was calculated daily as the loss of weight of test material from the generator divided by the total air flow through the chamber. In addition, a limited number of filters were analyzed using FTIR to evaluate shifts in composition over time.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/day, 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.05 mg/L air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 0.06 mg/L air (analytical)
- Dose / conc.:
- 0.15 mg/L air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 0.15 mg/L air (analytical)
- Dose / conc.:
- 0.5 mg/L air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 0.52 mg/L air (analytical)
- Dose / conc.:
- 50 mg/m³ air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 60 mg/m³ air (analytical)
- Dose / conc.:
- 150 mg/m³ air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 150 mg/m³ air (analytical)
- Dose / conc.:
- 500 mg/m³ air (nominal)
- Remarks:
- Target value
- Dose / conc.:
- 520 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 15 (core groups)
10 (additional ancilliary males in each group for specialized endpoints) - Control animals:
- yes, concurrent no treatment
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily, during exposure each 30 min
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily before exposure
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: before necropsy
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes
- How many animals: 15/sex/group
- Parameters checked: White blood cell count (WBC), red blood cell count (RaC), haemoglobin (Hb), haematocrit (Het), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular haemoglobin concentration (MCHC), platelets and differential white blood cell count.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: before necropsy
- Animals fasted: Yes
- How many animals:15/sex/group
- Parameters checked: Glucose, creatinine, urea nitrogen, uric acid, cholesterol, triglycerides, total bilirubin, total protein, albumin, globulin, A/G ratio, sorbitol dehydrogenase (SDH), alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase (ALP), Cl, Ca, Na, K, and P. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Adrenals, brain, epididymides, heart, kidney, liver, ovaries, prostate, spleen, testes, thymus, and uterus. Wet and dry weights of the right middle lung lobe were also measured. Lung, trachea, larynx and portions of the kidney and liver were preserved in a glutaraldehyde-formalin fixative
HISTOPATHOLOGY: Yes. Sham-exposed controls and animals in the high-dose group: Adrenals, sternum, brain (3 sections), eye and optic nerve, heart, colon and duodenum, kidneys, liver, lung (left lobe), thigh muscle, sciatic nerve, spleen, ovaries, pancreas, submaxillary gland, stomach, testes, thymus, thyroid, tracheobronchial lymph nodes, nasal turbinates (4 sections), urinary bladder, gross lesions. In addition, the lungs and tracheobronchial lymph nodes of untreated controls and the two other, exposed groups were similarly processed. - Other examinations:
- The ancillary animals were included to provide information on endpoints on the lung which could not be performed without using some of the lung tissue and thus preventing subsequent histopathology. They were anesthetized and used for pulmonary function tests (deflation pressure-volume curves and functional residual capacity).
After the pulmonary function tests, the rats were exsanguinated and the lung lobes were removed and weighed. The right middle and postcaval lobes were frozen and saved for analysis of hydroxyproline content as an index of collagen and development of fibrosis. - Statistics:
- Numerical data were analyzed by use of SAS. a computerized statistical analysis system. Values for body weights, organ weights, lung volumes, and pulmonary hydroxyproline were compared by use of ANOVA (analysis of variance) and Duncan's multiple range comparison test. Data on haematology, serum chemistry, and sperm were compared with ANOVA and Tukey's studentized range test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 530 mg/m³ (female): increased globulin and bilirubin relative to sham-exposed but not to untreated controls, not treatment related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 150 and 520 mg/m³: increased weight of right middle lung lobe, small red areas and plaques on the surface of the lungs.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- see Table 2 under "Any other information on results incl. tables".
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No treatment-related abnormalities were noted.
BODY WEIGHT AND WEIGHT GAIN
Statistically greater weights in selected males at the beginning of exposures were observed but not considered to be treatment-related (see Table 1 and 2 under “Any other information on results incl. tables”).
HAEMATOLOGY
Total WBC tended to be higher with higher doses and were statistically different for males in the high-dose group relative to untreated controls (but not to sham-exposed controls). Among WBC counts, there tended to be a shift in the relative proportion of cell types, with an increased percent of segmented neutrophils and a decrease in lymphocytes (see Table 3 under "Any other information on results incl. tables").
CLINICAL CHEMISTRY
Globulin was significantly increased by 17% in females of the high-dose group relative to sham-exposed but not to untreated controls. Total bilirubin was increased in females of the high-dose group by 47% compared to sham-exposed controls, but was almost identical to untreated controls. These statistically significant differences were minor and did not appear to be related to exposures (additional details are in a not available report on serum chemistry). Strong statistical differences were found only in the females receiving the two higher concentrations (additional details are given in a not available report on haematology).
ORGAN WEIGHTS
Wet and dry weight of the right middle lung lobe increased in a concentration-related manner (see Table 4 under "Any other information on results incl. tables"), each was significantly increased in both sexes in the two higher dose groups. The relative increases in mean weights were similar in both sexes. Dry weight increased proportionately more than wet weight. No significant changes in organ weights were observed in any other organs.
GROSS PATHOLOGY
At necropsy, small red areas and plaques were observed on the surface of the lungs, primarily in exposed animals. All rats in the two higher dose groups had plaques. No other significant treatment-related gross lesions were observed (additional details are given in a not available pathology report).
HISTOPATHOLOGY:
LUNGS
The response of the lungs to the aerosol consisted of foamy macrophages in the alveoli and alveolar walls, very mild thickening of alveolar walls due to foamy macrophages and a mixed cell inflammatory infiltrate, and subtle Type 2 cell hyperplasia. The incidence is summarized in Table 5 under “Any other information on results incl. tables”. Other related changes in the lungs were observed, namely, subacute inflammation, hyperplasia of Type 2 epithelial cells in alveoli, and thickening of the alveolar walls. The inflammation consisted of an increase of lymphocytes and a few polymorphonuclear leukocytes in the interstitium and alveoli. The inflammation was focal and mild. It tended to increase in severity with dose and become more multifocal, although it still remained only a mild change. The nature and severity of the other responses changed with aerosol concentration. In the most severe case, 20 - 30% of the alveoli of rats exposed to 0.52 mg/L contained foamy macrophages. However, no aggregates were severe enough to fill any given alveolus and in the alveolar walls, there was no microscopic evidence of an increase in connective tissue fibers. The overall response appeared to be an increase of free cells, such as macrophages, to the increased load of panicles on the alveolar surface. The response was present with 0.06 mg/L, in mild form, and increased with concentration.
OTHER ORGANS
Enlarged tracheobronchial lymph nodes were noted at necropsy in 0, 0, 3, 10, and 28 animals of groups 1, 2, 3, 4 and 5, respectively. Microscopically, these lymph nodes contained foamy macrophages; the number of macrophages appeared to correlate well with the effects in the lung. Foamy macrophages were also seen in the anterior mediastinal and thymic lymph nodes. No treatment-related effects were seen in any of the other tissues examined, including the nasal passages.
OTHER FINDINGS
NUMBER AND MORPHOLOGY OF SPERM
The test substance did not adversely affect the number of testicular spermatids or epididymal sperm and did not alter the morphology of the sperm. Additional details are given in an unavailable report on evaluation of sperm.
PULMONARY FUNCTION AND HYDROXYPROLINE IN ANCILLARY ANIMALS
As seen with the right middle lobe alone in the core animals, wet weight increased in a concentration-related manner. The total weight in all 3 exposed groups was significantly greater than either control group and also different from each other. Compared to the two control groups, mean lung weights were increased by 12, 29, and 76% for groups 3, 4, and 5, respectively. Lung volumes were also measured in the ancillary animals. Residual volume (RV) is the volume remaining in the lungs at the end of a forced expiration. Functional residual capacity (FRC) is the volume remaining at the end of a normal exhalation. RV and FRC are measures of lung volume when the lungs are inflated to only a small amount of their total capacity. TLC is the total lung capacity, the volume at maximal expansion. Lung volumes from the present study are among the parameters summarized in Table 4 under "Any other information on results incl. tables". Body weight was equivalent among the groups, indicating that no significant differences showed have resulted from variation in body size. Most of the lung volumes were also unaffected by exposure except the 2 lowest volumes, functional residual capacity and residual volume with exposure to 0.52 mg/L. Each was significantly lower than the sham-exposed controls, but not significantly different from the untreated controls. The significance of these stastistical differences is marginal because 1) they exist only in relation to sham-exposed controls and 2) an outlier in the sham-exposed controls seems to have skewed the data for that group. Therefore, the author concluded that there was a trend toward a decrease in the lower lung volumes with exposure to 0.52 mg/L.
Quasistatic pressure-volume curves represent lung volumes at specific transpulmonary pressures as the lungs are slowly deflated from a maximal inflation to a maximal deflation. There were no treatment-related changes. Pulmonary compliance is derived from the pressure-volume curves as the change in lung volume over specified ranges of transpulmonary pressure. Compliance was unaffected by exposure. Specific compliance is the compliance over a given range of pressure divided by the absolute lung volume at the midpoint of that pressure range. The intent is to standardize compliance to lung volume. It also was unaffected by exposure.
Data on hydroxyproline in the postcaval lung lobe are summarized in Table 5. Pulmonary hydroxyproline, is a measure of the connective tissue fiber, collagen. The amount of hydroxyproline per lobe was significantly greater in rats exposed to 0.52 mg/L than the untreated controls; but there was not a significant increase above the sham-exposed group. The wet weight of the postcaval lobe, in contrast was significantly greater than both control groups for groups exposed to 0.15 or 0.52 mg/L. The wet weight in the high-dose group tended to increase more than the hydroxyproline content, leading to a statistically insignificant tendency for reduced µg OHPro/mg lung.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 520 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOEC
- Effect level:
- 150 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Mean body weights of male rats.
Mean body weights [g] |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
1 |
433.0 |
440.0 |
453.0 |
452.0 |
455.0 |
2 |
460.0 |
465.0 |
476.0 |
469.0 |
478.0 |
3 |
476.0 |
490.0 |
503.0 |
494.0 |
502.0 |
4 |
498.0 |
504.0 |
525.0 |
519.0 |
513.0 |
5 |
518.0 |
520.0 |
539.0 |
534.0 |
524.0 |
6 |
533.0 |
534.0 |
555.0 |
547.0 |
540.0 |
7 |
549.0 |
550.0 |
571.0 |
565.0 |
550.0 |
8 |
559.0 |
559.0 |
582.0 |
574.0 |
563.0 |
9 |
577.0 |
571.0 |
588.0 |
582.0 |
576.0 |
10 |
584.0 |
582.0 |
597.0 |
586.0 |
589.0 |
11 |
590.0 |
593.0 |
606.0 |
598.0 |
597.0 |
12 |
593.0 |
601.0 |
617.0 |
608.0 |
605.0 |
13 |
606.0 |
612.0 |
627.0 |
624.0 |
616.0 |
14 |
602.0 |
601.0 |
611.0 |
611.0 |
603.0 |
Mean |
541.3 |
544.4 |
560.7 |
554.5 |
550.8 |
*: P<0.05 from Group 1
Table 2. Mean body weights of female rats.
Mean body weights [g] |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
1 |
263.0 |
266.0 |
267.0 |
278.0 |
273.0 |
2 |
274.0 |
272.0 |
280.0 |
285.0 |
277.0 |
3 |
284.0 |
285.0 |
291.0 |
292.0 |
288.0 |
4 |
289.0 |
290.0 |
295.0 |
307.0 |
300.0 |
5 |
300.0 |
294.0 |
304.0 |
310.0 |
303.0 |
6 |
305.0 |
301.0 |
308.0 |
312.0 |
307.0 |
7 |
310.0 |
307.0 |
314.0 |
317.0 |
312.0 |
8 |
316.0 |
310.0 |
318.0 |
320.0 |
319.0 |
9 |
325.0 |
317.0 |
320.0 |
325.0 |
323.0 |
10 |
325.0 |
321.0 |
328.0 |
330.0 |
325.0 |
11 |
335.0 |
326.0 |
332.0 |
335.0 |
330.0 |
12 |
340.0 |
328.0 |
335.0 |
336.0 |
337.0 |
13 |
337.0 |
334.0 |
340.0 |
342.0 |
340.0 |
14 |
327.0 |
322.0 |
328.0 |
327.0 |
328.0 |
Mean |
309.3 |
305.2 |
311.4 |
315.4 |
311.6 |
Table 3. Segmented neutrophiles and lymphocytes as percent of total white blood cells and total number of white blood cells (thousands/µl).Values are mean ± SD.
|
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
Males |
|||||
WBC |
13.6 ± 2.5 |
14.9 ± 2.2 |
14.5 ± 2.9 |
16.8 ± 3.1 |
17.5 ± 3.9a |
Segmented neutrophiles |
14 ± 6 |
17 ± 6 |
17 ± 11 |
15 ± 6 |
22 ± 6a |
lymphocytes |
84 ± 6 |
81 ± 5 |
82 ± 12 |
84 ± 6 |
77 ± 6 |
Females |
|||||
WBC |
10.9 ± 2.7 |
9.3 ± 2.8 |
10.3 ± 2.0 |
11.0 ± 2.2 |
12.1 ± 2.8 |
Segmented neutrophiles |
13 ± 4 |
12 ± 6 |
15 ± 7 |
22 ± 6bd |
25 ± 7bd |
lymphocytes |
86 ± 5 |
87 ± 6 |
83 ± 7 |
77 ± 6bd |
74 ± 7bd |
Significantly different from Group 1: a= p<0.05; b =p<0.01, different from Group 2: d=p<0.01
Table 4. Wet and dry weights (mg) and dry/wet ratio (%) of right middle lung lobe. Values are mean ± SD.
Weight |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
Males |
|||||
Wet |
185 ± 27 |
192 ± 32 |
197 ± 21 |
226 ± 26a |
310 ± 40a |
Dry |
35 ± 4 |
36 ± 4 |
40 ± 4b |
49 ± 5a |
82 ± 13a |
Dry/Wet |
19.0 ± 1.4 |
19.1 ± 2.1 |
20.4 v 1.4 |
21.8 ± 1.7a |
26.4 ± 1.7a |
Females |
|||||
Wet |
132 ± 25 |
130 ± 19 |
140 ± 14 |
164 ± 16a |
220 ± 18a |
Dry |
25 ± 4 |
26 ± 6 |
28 ± 4 |
35 ± 4a |
59 ± 6a |
Dry/Wet |
19.2 ± 1.7 |
20.3 ± 5.3 |
19.8 ± 2.0 |
21.7 ± 2.3 |
26.8 ± 2.2a |
a) Significantly different from both control groups.
b) Significantly different only from untreated controls.
Table 5. Incidence of microscopic changes in left lung lobe, 15 animals examined/sex.
|
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
|
Males |
||||
1-2 FAM |
0 |
0 |
15 |
15 |
15 |
Occasional AGGs |
0 |
0 |
9 |
|
|
Few AGGs |
0 |
0 |
|
15 |
|
Many AGGs |
0 |
0 |
|
|
15 |
FAM in alveolar walls |
0 |
0 |
15 |
15 |
15 |
Type 2 cell hyperplasia |
0 |
0 |
9 |
15 |
15 |
Occasional thick alveolar walls |
0 |
0 |
7 |
15 |
|
Some thick alveolar walls |
0 |
0 |
|
|
15 |
Subacute inflammation |
2 |
2 |
0 |
2 |
7 |
|
Females |
||||
1-2 FAM |
0 |
0 |
15 |
15 |
15 |
Occasional AGGs |
0 |
0 |
5 |
|
|
Few AGGs |
0 |
0 |
|
14 |
|
Many AGGs |
0 |
0 |
|
|
15 |
FAM in alveolar walls |
0 |
0 |
15 |
15 |
15 |
Type 2 cell hyperplasia |
0 |
0 |
5 |
15 |
15 |
Occasional thick alveolar walls |
0 |
0 |
5 |
15 |
|
Some thick alveolar walls |
0 |
0 |
|
|
15 |
Subacute inflammation |
0 |
5 |
0 |
3 |
11 |
FAM = foamy alveolar macrophages
AGG = Aggregates of 4 or more foamy alveolar macrophages
Occasional AGGs = 2-3 FAM in < 10% of alveoli
Few AGGs = 2-3 FAM in 10-20% of alveoli
Many AGGs = More FAM7alveolus, > 20 % of alveoli with FAM, aggregates not large enough to fill any alveolus
Occasional thick alveolar walls = Mild thickening in a few alveolar walls
Some Thick alveolar walls = Increased thickening, but still mild; no increase in visible connective tissue in walls
Table 6. Hydroxyproline in postcaval lung lobe and weight of the lobe.Values are mean ± SD.
|
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Group 5 |
µg OHPro |
347 ± 102 |
412 ± 104 |
456 ± 161 |
440 ± 137 |
478 ± 83a |
Wet weight (mg) |
163 ± 18 |
179 ± 21 |
191 ± 20a |
214 ± 25b |
291 ± 24b |
µg OHPro/mg PCL |
2.1 ± 0.4 |
2.3 ± 0.5 |
2.3 ± 0.7 |
2.1 ± 0.6 |
1.7 ± 0.3 |
a = Significantly different from group 1
b = Significantly different from group 1 and 2
Applicant's summary and conclusion
- Conclusions:
- Exposure concentrations as high as 520 mg/m³ resulted in mild histologic changes limited to the lung. The changes were expected results of the particle load resulting from the high aerosol concentrations and represented a nonspecific response to a relatively innocuous aerosol.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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