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EC number: 204-024-4 | CAS number: 113-24-6
- 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:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Version / remarks:
- 2009
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium pyruvate
- EC Number:
- 204-024-4
- EC Name:
- Sodium pyruvate
- Cas Number:
- 113-24-6
- Molecular formula:
- C3H4O3.Na
- IUPAC Name:
- sodium 2-oxopropanoate
- Test material form:
- solid
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 Laboratories (Raleigh, NC)
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 248.5-250.2 g (males) and 199.5-200.2 g (females)
- Housing: housed in pairs in cages with softwood granulate bedding and environmental enrichment was provided
- Diet: gamma-irradiated pellet diet, ad libitum
- Water: sterilized drinking water, ad libitum
- Acclimation period: ≥ 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 52-55
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: phosphate-buffered saline (PBS)
- Mass median aerodynamic diameter (MMAD):
- ca. 1.5 µm
- Geometric standard deviation (GSD):
- 1.75
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past nose-only exposure chambers
- System of generating particulates/aerosols: Aerosols were generated by Collison Nebulizers and diluted with filtered conditioned fresh air.
- Air flow rate: continuous flow rate
- Method of particle size determination: Aerodynamic particle size (APS) spectrometer
TEST ATMOSPHERE
- Brief description of analytical method used: Levels of pyruvate were measured by enzymatic means by a commercial Pyruvate Detection kit (Cayman Chemicals, Ann Arbor, MI) in total particulate matter (TPM) samples of the aerosols collected on Cambridge filter pads.
VEHICLE
- Composition of vehicle: phosphate-buffered saline - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Levels of pyruvate were measured by enzymatic means by a commercial Pyruvate Detection kit (Cayman Chemicals, Ann Arbor, MI) in total particulate matter (TPM) samples of the aerosols collected on Cambridge filter pads. Sampled were taken at least 3 times a day with a sampling time of 20 minutes. The analytical method used was an indirect enzymatic fluorescence assay.
- Duration of treatment / exposure:
- 6 hours / day
- Frequency of treatment:
- 5 days / week
Doses / concentrations
- Dose / conc.:
- 0.034 mg/L air
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: a range finding study was performed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations included check for mortality and health status
DETAILED CLINICAL OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: at least twice a week
FOOD CONSUMPTION:
- Food consumption was determined by gravimetry once a week.
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day 28
- Anaesthetic used for blood collection: Yes, pentobarbital
- Animals fasted: No
- How many animals: all animals
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on day 28
- Animals fasted: No
- How many animals: all animals
- Parameters checked in table 2 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: once during the study
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: No
- Parameters checked in table 3 were examined.
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table 4 and table 5)
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- All rats had an increase in body weight throughout the exposure period. No effects compared with sham groups were observed.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No exposure-related effects were observed in male and female rats.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No exposure-related effects were observed in male and female rats.
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- A fecal contamination occured. Therefore, data were not reported.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Spleen weights in female rats elicited a different response, with higher weights after exposure to sodium pyruvate. This result in females, however, appeared to be due to the low spleen weight in the sham group. No exposure-related effects were observed in male and female rats.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were several macroscopic observations of organs at necropsy; but they were specifically related to neither treatment nor exposure concentration.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the mid-base of epiglottis a slight increase in ventral-squamous hyperplasia was observed in males exposed to sodium pyruvate. Overall cytoplasmic vacuolation of hepatocytes was observed in the livers of most rats of the study, and increased vacuolation could be observed in rats exposed to sodium pyruvate. Vacuolation was increased in the livers of female rats that inhaled sodium pyruvate compared with sham and PBS control females, but this difference was small. A similar effect was not seen in males, and sodium pyruvate was not considered to have contributed to this change.
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.034 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: No adverse effects observed up to the highest concentration tested.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
Table 6: Organ weights in male rats
|
|
Sham |
PBS |
Sodium Pyruvate |
Liver |
g |
11.77 ± 0.391 |
12.19 ± 0.455 |
12.08 ± 0.360 |
X10E-4 |
348.97 ± 7.986 |
371.22 ± 7.420 |
362.39 ± 7.275 |
|
N |
10 |
10 |
10 |
|
Spleen |
g |
0.69 ± 0.040 |
0.73 ± 0.099 |
0.65 ± 0.031 |
X10E-4 |
20.61 ± 1.173 |
22.40 ± 3.130 |
19.53 ± 0.942 |
|
N |
10 |
10 |
10 |
|
Left adrenal |
g |
0.03 ± 0.009 |
0.02 ± 0.002 |
0.03 ± 0.001 |
X10E-4 |
0.97 ± 0.257 |
0.75 ± 0.078 |
0.78 ± 0.036 |
|
N |
10 |
8 |
10 |
|
Right adrenal |
g |
0.02 ± 0.002 |
0.03 ± 0.001 |
0.02 ± 0.001 |
X10E-4 |
0.73 ± 0.045 |
0.77 ± 0.036 |
0.71 ± 0.030 |
|
N |
9 |
9 |
10 |
|
Left kidney |
g |
1.07 ± 0.032 |
1.04 ± 0.055 |
1.03 ± 0.021 |
X10E-4 |
31.89 ± 0.722 |
31.95 ± 1.688 |
30.92 ± 0.713 |
|
N |
10 |
10 |
10 |
|
Right kidney |
g |
1.09 ± 0.031 |
1.08 ± 0.056 |
1.03 ± 0.026 |
X10E-4 |
32.20 ± 0.738 |
33.10 ± 1.812 |
31.07 ± 0.629 |
|
N |
10 |
10 |
10 |
|
Thymus |
g |
0.31 ± 0.021 |
0.31 ± 0.023 |
0.34 ± 0.026 |
X10E-4 |
9.12 ± 0.598 |
9.43 ± 0.583 |
10.23 ± 0.776 |
|
N |
10 |
10 |
10 |
|
Lung/Larynx/ Trachea |
g |
1.40 ± 0.025 |
1.44 ± 0.047 |
1.46 ± 0.047 |
X10E-4 |
41.76 ± 1.064 |
44.21 ± 1.480 |
44.08 ± 1.950 |
|
N |
10 |
9 |
10 |
|
Brain |
g |
2.05 ± 0.023 |
2.04 ± 0.072 |
2.08 ± 0.033 |
X10E-4 |
60.94 ± 1.146 |
62.21 ± 2.088 |
62.39 ± 0.955 |
|
N |
10 |
10 |
10 |
|
Heart |
g |
1.07 ± 0.034 |
1.08 ± 0.025 |
1.07 ± 0.020 |
X10E-4 |
31.82 ± 0.760 |
33.08 ± 0.491 |
32.18 ± 0.802 |
|
N |
10 |
10 |
10 |
|
Left testis |
g |
1.63 ± 0.046 |
1.36 ± 0.140 |
1.66 ± 0.025 |
X10E-4 |
48.25 ± 1.204 |
41.74 ± 4.378 |
50.00 ± 1.204 |
|
N |
10 |
10 |
10 |
|
Right testis |
g |
1.61 ± 0.051 |
1.38 ± 0.142 |
1.61 ± 0.034 |
X10E-4 |
47.94 ± 1.358 |
42.12 ± 4.429 |
48.62 ± 1.433 |
|
N |
10 |
10 |
10 |
Absolute and relative body weight, mean ± SD
Table 7: Organ weights in female rats
|
|
Sham |
PBS |
Sodium Pyruvate |
Liver |
g |
9.17 ± 0.387 |
10.02 ± 0.507 |
9.50 ± 0.293 |
X10E-4 |
388.30 ± 11.643 |
418.08 ± 21.681 |
406.83 ± 8.813 |
|
N |
10 |
10 |
10 |
|
Spleen |
g |
0.46 ± 0.027 |
0.61 ± 0.069+ |
0.55 ± 0.028* |
X10E-4 |
19.80 ± 1.060 |
25.50 ± 3.115 |
23.64 ± 1.095* |
|
N |
9 |
9 |
10 |
|
Left adrenal |
g |
0.04 ± 0.013 |
0.04 ± 0.001 |
0.03 ± 0.001 |
X10E-4 |
1.85 ± 0.486 |
1.53 ± 0.045 |
1.42 ± 0.048 |
|
N |
9 |
9 |
10 |
|
Right adrenal |
g |
0.03 ± 0.002 |
0.03 ± 0.001 |
0.03 ± 0.001 |
X10E-4 |
1.27 ± 0.105 |
1.31 ± 0.056 |
1.42 ± 0.048 |
|
N |
8 |
9 |
10 |
|
Left kidney |
g |
0.77 ± 0.016 |
0.85 ± 0.059 |
0.78 ± 0.019 |
X10E-4 |
33.01 ± 0.629 |
35.69 ± 2.555 |
33.37 ± 0.585 |
|
N |
9 |
9 |
10 |
|
Right kidney |
g |
0.78 ± 0.017 |
0.83 ± 0.037 |
0.82 ± 0.017 |
X10E-4 |
33.35 ± 0.618 |
34.89 ± 1.603 |
35.02 ± 0.688 |
|
N |
9 |
9 |
10 |
|
Thymus |
g |
0.35 ± 0.034 |
0.45 ± 0.103 |
0.33 ± 0.024 |
X10E-4 |
14.81 ± 1.412 |
18.24 ± 4.025 |
14.22 ± 0.900 |
|
N |
10 |
9 |
10 |
|
Lung/Larynx/ Trachea |
g |
1.27 ± 0.036 |
1.56 ± 0.175 |
1.19 ± 0.026 |
X10E-4 |
53.86 ± 1.382 |
64.77 ± 6.851 |
51.10 ± 1.212 |
|
N |
9 |
9 |
10 |
|
Brain |
g |
1.85 ± 0.091 |
2.00 ± 0.034 |
1.89 ± 0.034 |
X10E-4 |
79.00 ± 4.427 |
83.52 ± 1.590 |
81.25 ± 2.316 |
|
N |
10 |
8 |
10 |
|
Heart |
g |
0.91 ± 0.073 |
0.83 ± 0.062 |
0.82 ± 0.021 |
X10E-4 |
38.46 ± 2.629 |
34.59 ± 2.830 |
35.40 ± 0.876 |
|
N |
10 |
10 |
10 |
Absolute and relative body weight, mean ± SD, *p<0.05
Applicant's summary and conclusion
- Conclusions:
- No treatment-related effects were observed in Sprague-Dawley rats after inhalative nose-only exposure to sodium pyruvate (33.9 µg/L) for 28 days, 6 h/day, 5 days/week.
- Executive summary:
A sub-chronic inhalation study according to OECD guideline 412 was performed with Sprague-Dawley rats. The rats were nose-only exposed, 6 h/day, 5 days/week for 28 days to filtered air, saline, nicotine (50 µg/L), sodium pyruvate (33.9 µg/L) or equimolar nicotine/pyruvic acid mixtures (18, 25 and 50 µg nicotine/L).
After exposure to sodium pyruvate no exposure-related effects on body weight, haematological parameters and clinical parameters were observed. Spleen weights in female rats elicited a different response, with higher weights after exposure to sodium pyruvate. This result in females, however, appeared to be due to the low spleen weight in the sham group. No further changes in organ weights were observed after exposure to sodium pyruvate. No treatment-related gross pathological findings were revealed after inhalation of sodium pyruvate. In the mid-base of epiglottis a slight increase in ventral-squamous hyperplasia was observed in males exposed to sodium pyruvate. Overall cytoplasmic vacuolation of hepatocytes was observed in the livers of most rats of the study, and increased vacuolation could be observed in rats exposed to sodium pyruvate. Vacuolation was increased in the livers of female rats that inhaled sodium pyruvate compared with sham and PBS control females, but this difference was small. A similar effect was not seen in males, and sodium pyruvate was not considered to have contributed to this change. These results suggest that aerosols of sodium pyruvate did not result in substantial toxicity.
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