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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-08-05 - 2015-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 439 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:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- B.46 BIS. “IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN EPIDERMIS MODEL TEST”, dated 24. Aug. 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Version 439, 26. July 2013, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- 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
- Species:
- other: EpiDermTM tissue consisting of human-derived epidermal keratinocytes
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: DPBS-buffer was used as negative control, 5 % SDS solution was used as positive control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30µL - Duration of treatment / exposure:
- 60 min
- Observation period:
- 42 h postincubation + 3 h incubation with MTT
- Number of animals:
- in total, 3 6-well plates were used
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with DPBS buffer
- Time after start of exposure: 60 min
SCORING SYSTEM: Formazan production as described in OECD Guideline 439
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Formazan production
- Value:
- 46.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h incubation, 42h postincubation. Reversibility: other: not applicable. Remarks: Test item; below the threshold for skin irritation (50%).. (migrated information)
- Irritation / corrosion parameter:
- other: other: Formazan production
- Value:
- 3.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h incubation, 42h postincubation. Reversibility: other: not applicable. Remarks: Positive control; below the threshold for skin irritation (50%).. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative absorbance values were reduced to 46.6 % after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin. For details see "Any other information on results incl. tables"
Any other information on results incl. tables
Findings and Results
Measured Values
As blank, the optical density of isopropanol was measured in eight wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table Absorbance values blank isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.036 |
0.036 |
0.036 |
0.037 |
0.034 |
0.035 |
0.036 |
0.035 |
0.036 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table Absorbance Values negative control, test item and positive control (OD at 570 nm)
Designation |
Measurement |
Negative Control |
3-Acetylpyridine |
Positive Control |
Tissue 1 |
1 |
1.925 |
0.926 |
0.101 |
2 |
1.922 |
0.935 |
0.102 |
|
Tissue 2 |
1 |
1.830 |
0.895 |
0.098 |
2 |
1.857 |
0.900 |
0.097 |
|
Tissue 3 |
1 |
1.804 |
0.826 |
0.087 |
2 |
1.800 |
0.826 |
0.088 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol. Mean and relative standard deviation (comparison of the three tissues) were also calculated.
Table Mean Absorbance Values
Designation |
Negative Control |
3-Acetylpyridine |
Positive Control |
Mean – blank (tissue 1) |
1.888 |
0.895 |
0.066 |
Mean – blank (tissue 2) |
1.808 |
0.862 |
0.062 |
Mean – blank (tissue 3) |
1.766 |
0.790 |
0.052 |
Mean of the three tissues |
1.821 |
0.849 |
0.060 |
Relative standard deviation |
3.4% |
6.3% |
12.0% |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:
Table % Formazan Production
Designation |
3-Acetylpyridine |
Positive Control |
% Formazan production (tissue 1) |
49.1% |
3.6% |
% Formazan production (tissue 2) |
47.3% |
3.4% |
% Formazan production (tissue 3) |
43.4% |
2.9% |
% Formazan production (mean) |
46.6% |
3.3% |
Assessment and Validity
Skin Irritation Potential of the Test Item
The relative absorbance values were reduced to 46.6 % after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin.
Validity and Acceptability
Validity criteria and results are stated in the following table:
Table Validity
Criterion |
Demanded |
Found |
OD of negative control |
≥ 0.8 and ≤ 2.8 |
1.8 |
% Formazan production |
<=20% of negative control |
3.3% |
Variation within replicates (RSD) |
< 18% |
3.4% (negative control) |
All validity criteria were met.
Values for negative control and for positive control were within the range of historical data of the test facility.
Therefore, the experiment is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Testing was performed via a GLP OECD 439 guideline study on the registered substance itself. The present in vitro method is recommended in a tiered testing approach, it was used as follow-up study to an OECD 431 study in which 3-Acetylpyridine was found to be non-corrosive to skin.
The validity criteria are met, making the results sufficiently reliable to assess the irritating potential of 3-Acetylpyridine to the skin. The present in vitro method allows the identification of irritating chemical substances and mixtures.
The relative absorbance values were reduced to 46.6 % after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin according to the guideline. - Executive summary:
In an OECD 439 (in vitro skin irritation) study under GLP, 1 valid experiment was performed.
3 tissues of the human skin model EpiDermTM were treated with 3-Acetylpyridine for 60 minutes.
30 µL of the test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm²; as indicated by supplier).
DPBS-buffer was used as negative control, 5 % SDS solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.8. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.3 %.
Variation within tissues was acceptable (< 18%).
After the treatment with the test item, the relative absorbance values were reduced to 46.6 %. This value is below the threshold for irritation potential (50%).
Therefore, 3-Acetylpyridine is considered as skin irritant in the Human Skin Model Test.
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