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EC number: 206-496-7 | CAS number: 350-03-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-09-02 - 2015-11-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 437 guideline study without deviations on the registered substance itself.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- OECD Guideline No. 437, edition adopted 26. Jul. 2013: “Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- EU Method B. 47: “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants” adopted 09. Dec. 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, 55116 Mainz, Germany
Test material
- Reference substance name:
- 3-Acetylpyridine
- IUPAC Name:
- 3-Acetylpyridine
- Reference substance name:
- Methyl 3-pyridyl ketone
- EC Number:
- 206-496-7
- EC Name:
- Methyl 3-pyridyl ketone
- Cas Number:
- 350-03-8
- Molecular formula:
- C7H7NO
- IUPAC Name:
- 1-(pyridin-3-yl)ethan-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 3-Acetylpyridine
- Substance type: pure substance
- Storage condition of test material: Room temperature (20 ± 5 °C)
- Homogeneity: homogeneous
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (fresh bovine corneas)
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 0.9% NaCl in demin. water (negative control), Dimethylformamide undiluted (positive control)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 10 min
- Observation period (in vivo):
- 2 h + 90 min post-incubation
- Number of animals or in vitro replicates:
- 3 replicate corneas for each treatment group (negative control solution, test item and positive control)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red
- Time after start of exposure: 10 min
SCORING SYSTEM: Opacity value, calculated from the measured absorbance at 570 nm
TOOL USED TO ASSESS SCORE: fluorescein absorbance measurement
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #1
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 58.02
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 1st experiment; IVIS>55, Eye damage Category I
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #2
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 56.98
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 1st experiment; IVIS>55, Eye damage Category I
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #3
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 40.21
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 1st experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 51.74
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 1st experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 86.24
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Positive control; 1st experiment; IVIS>55, Eye damage Category I
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 1.64
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Negative control; 1st experiment; IVIS ≤ 3, No category
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #1
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 51.85
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 2nd experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #2
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 34.5
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 2nd experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- other: cornea #3
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 40.14
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 2nd experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 42.16
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test item; 2nd experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 28.53
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Positive control; 2nd experiment; IVIS > 3 and ≤ 55, No prediction can be made
- Irritation parameter:
- other: IVIS (in vitro irritancy score)
- Basis:
- mean
- Remarks:
- all corneas
- Time point:
- other: 10 min incubation, 210 min postincubation
- Score:
- 0.27
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Negative control; 2nd experiment; IVIS ≤ 3, No category
- Irritant / corrosive response data:
- In the negative control, no signs of eye irritation were observed in both experiments.
In the first experiment, the positive control induced serious eye damage, which would be classified as GHS category 1. In the second experiment, the positive control showed effects on the cornea of the bovine eye.
The test item 3-Acetylpyridine showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 51.74 in the first experiment and 42.16 in the second experiment.
Any other information on results incl. tables
Findings and Results
Two experiments were performed. The first experiment was insufficient for classification because 2 of the 3 replicates gave discordant predictions from the mean. The second experiment was valid and sufficient for classification.
Opacity and Permeability Values of the First Experiment
For each treatment group (negative control solution, test item and positive control), three replicates were measured.
The absorbance (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Table Absorbance and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorbance before exposition |
0.1470 |
0.1538 |
0.1572 |
Absorbance after exposition |
0.1946 |
0.1689 |
0.2103 |
Opacity before exposition |
1.4028 |
1.4250 |
1.4362 |
Opacity after exposition |
1.5653 |
1.4754 |
1.6229 |
Opacity Difference |
0.1625 |
0.0504 |
0.1868 |
Mean opacity difference of the negative control is 0.1332.
Table Absorbance and Opacity Values Test Item and Positive Control
Parameter |
Test Item3-Acetylpyridine |
Positive Control |
||||
Absorbance before exposition |
0.1266 |
0.1427 |
0.1681 |
0.1947 |
0.1535 |
0.1125 |
Absorbance after exposition |
1.4215 |
1.4031 |
1.4020 |
1.9553 |
1.4636 |
2.0453 |
Opacity before exposition |
1.3384 |
1.3890 |
1.4727 |
1.5657 |
1.4240 |
1.2957 |
Opacity |
26.3937 |
25.2988 |
25.2348 |
90.2194 |
29.0804 |
110.9941 |
Opacity |
25.0552 |
23.9098 |
23.7622 |
88.6537 |
27.6564 |
109.6984 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Table Optical density at 490 nm
Replicate |
Negative Control |
Test Item 3-Acetylpyridine |
Positive Control |
||||||
Measured values |
0.0181 |
0.0290 |
0.0133 |
0.4614 |
0.4629 |
0.2412 |
0.0873 |
0.2001 |
0.2144 |
*Corrected values |
0.0905 |
0.1450 |
0.0665 |
2.3070 |
2.3145 |
1.2060 |
0.4365 |
1.0005 |
1.0720 |
Mean |
0.1007 |
-- |
*Note: In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS.
IVIS Values of the First Experiment
IVIS was calculated using the values in tables and the equation stated above.
Example:
IVIS (Test Item 3-Acetylpyridine, Repl. 1) = (25.0552– 0.1332) + [15 * (2.3070– 0.1007)] = 58.02
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.52 |
1.64 |
32.3% |
2.23 |
|||
1.18 |
|||
Test Item |
58.02 |
51.74 |
19.3% |
56.98 |
|||
40.21 |
|||
Positive Control |
93.56 |
86.24 |
48.7% |
41.02 |
|||
124.14 |
Opacity and Permeability Values of the Second Experiment
For each treatment group (negative control solution, test item and positive control), three replicates were measured.
The absorbance (570 nm) and opacity values which were measured before and after exposition are given in the following table:
Table Absorbance and Opacity Values Negative Control
Parameter |
Negative Control |
||
Absorbance before exposition |
0.1510 |
0.1524 |
0.1513 |
Absorbance after exposition |
0.2742 |
0.2410 |
0.2125 |
Opacity before exposition |
1.4158 |
1.4204 |
1.4168 |
Opacity after exposition |
1.8802 |
1.7418 |
1.6312 |
Opacity Difference |
0.4644 |
0.3214 |
0.2144 |
Mean opacity difference of the negative control is 0.3334.
Table Absorbance and Opacity Values Test Item and Positive Control
Parameter |
Test Item3-Acetylpyridine |
Positive Control |
||||
Absorbance before exposition |
0.1718 |
0.1233 |
0.1739 |
0.1920 |
0.1791 |
0.2384 |
Absorbance after exposition |
1.3855 |
1.2214 |
1.3230 |
1.4546 |
1.2253 |
1.4819 |
Opacity before exposition |
1.4853 |
1.3283 |
1.4925 |
1.5560 |
1.5104 |
1.7314 |
Opacity |
24.2941 |
16.6495 |
21.0378 |
28.4839 |
16.7996 |
30.3319 |
Opacity |
22.8088 |
15.3211 |
19.5453 |
26.9280 |
15.2892 |
28.6005 |
For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:
Table Optical density at 490 nm
Replicate |
Negative Control |
Test Item3-Acetylpyridine |
Positive Control |
||||||
Measured values |
-0.0009 |
-0.0013 |
-0.0005 |
0.3908 |
0.2593 |
0.2781 |
0.0695 |
0.0689 |
0.0693 |
*Corrected values |
-0.0045 |
-0.0065 |
-0.0025 |
1.9540 |
1.2965 |
1.3905 |
0.3475 |
0.3445 |
0.3465 |
Mean |
-0.0045 |
-- |
*Note: In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS.
IVIS Values of the Second Experiment
IVIS was calculated using the values in tables and the equation stated above.
Example:
IVIS (Test Item3-Acetylpyridine, Repl. 1) = (22.8088–0.3334) + [15 * (1.9540 – (-0.0045))] = 51.85
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Table IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.40 |
0.27 |
43.6% |
0.22 |
|||
0.18 |
|||
Test Item |
51.85 |
42.16 |
21.0% |
34.50 |
|||
40.14 |
|||
Positive Control |
31.88 |
28.53 |
25.5% |
20.19 |
|||
33.53 |
Validity
According to the guideline, the test is considered as valid if the positive control causes an IVIS that falls within two standard deviations of the current historical mean.
The negative control has to show an IVIS ≤ 3.
The validity criteria and findings are given in the following table:
Table Validity
Parameter |
Criterion |
Found |
Assessment |
IVIS of negative control 0.9% NaCl |
≤ 3 |
1.64 (first experiment) 0.27 (second experiment) |
ok |
IVIS of positive control |
22.80 – 123.60 |
86.24 (first experiment) 28.53 (second experiment) |
ok |
Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the test system was acceptable.
Assessment
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category.
Table Classification Scheme
IVIS |
UN GHS Category Eye Damage |
≤ 3 |
No category |
> 3 and ≤ 55 |
No prediction can be made |
> 55 |
Eye damage Category I |
In the negative control, no signs of eye irritation were observed in both experiments.
In the first experiment, the positive control induced serious eye damage, which would be classified as GHS category 1. In the second experiment, the positive control showed effects on the cornea of the bovine eye.
The test item 3-Acetylpyridine showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 51.74 in the first experiment and 42.16 in the second experiment.
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive, no prediction can be made
- Conclusions:
- Testing was performed via a GLP OECD 437 guideline study on the registered substance itself. The present in vitro method is recommended in a tiered testing approach and the validity criteria are met, making the results sufficiently reliable to assess the corrosivity of 3-Acetylpyridine to the eye. The present in vitro method allows the identification of corrosive chemical substances and mixtures or of substances which do not require classification.
Two experiments were performed. The first experiment was insufficient for classification because 2 of the 3 replicates gave discordant predictions from the mean. The second experiment was valid and sufficient for classification. Under the conditions of this study, the test item 3-Acetylpyridine showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 51.74 in the first experiment and 42.16 in the second experiment.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage.
Hence, no conclusion can be drawn whether the substance needs to be classified as eye irritant, for a clear distinction an in vivo study would be required based on the current state of the art. However, based on the tonnage band o the substance, in vivo testing is not required, and with regard to animal welfare no further testing will be performed and the result of the present study will be considered inconclusive. - Executive summary:
In an OECD 437 (in vitro eye corrosion) study under GLP, two experiments were performed. The first experiment was insufficient for classification because 2 of the 3 replicates gave discordant predictions from the mean. The second experiment was valid and sufficient for classification.
Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item 3-Acetylpyridine was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test item was incubated on the cornea for 10 min. at 32 ± 1 °C. After removal of the test item and 2 h post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea in both experiments. The calculated IVIS (in vitro irritancy score) is 1.64 in the first experiment and 0.27 in the second experiment.
Dimethylformamide (DMF) undiluted was used as positive control. In the first experiment, the positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 86.24. In the second experiment, the positive control induced effects on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) is 28.53.
Under the conditions of this study, the test item 3-Acetylpyridine showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 51.74 in the first experiment and 42.16 in the second experiment.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage.
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