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EC number: 689-986-7 | CAS number: 1742-79-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 December 2012 to 05 August 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted according to current test guidelines and GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-oxo-1,2-dihydropyridin-1-yl acetate
- EC Number:
- 689-986-7
- Cas Number:
- 1742-79-6
- Molecular formula:
- C7H7NO3
- IUPAC Name:
- 2-oxo-1,2-dihydropyridin-1-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Oxypyrion-Acetate
CAS Number: 1742-79-6
Batch number: 11085913
Purity: Not stated
Date of arrival: 20 November 2012
Storage conditions: Refrigerated (2 to 8°C)
Constituent 1
Test animals / tissue source
- Species:
- other:
- Strain:
- other:
- Details on test animals or tissues and environmental conditions:
- Bovine corneas supplied by a local abattoir. The eyes were removed after slaughter, completely immersed in Hanks’ Balanced Salt Solution (containing penicillin at 100 IU/ml and streptomycin at 100 µg/ml) in a suitably sized container and transported on the same day to the testing facility.
Upon arrival at the test facility, the corneas were excised from the eyes and loaded onto the specifically designed holders. Both chambers of each holder were filled with pre-warmed Eagle’s Minimal Essential Medium (EMEM) (posterior chamber first), ensuring that no bubbles were formed. The holders were incubated at 32°C ± 1°C for at least 1 hour. After the incubation, the media was removed from both the anterior and posterior chambers. Fresh media was added to the posterior chamber first and then the anterior chamber (this media replacement order ensured the cornea retained its natural curvature as much as possible). The opacity of each cornea was measured using an opacitometer (model OP-KIT-3). Any corneas found to have scratches or increased neovascularization or an opacity of >7 opacity units when examined prior to treatment were discarded.
Test system
- Vehicle:
- other: The test item was tested as a 20% w/v solution in 0.9% sodium chloride solution.
- Controls:
- no
- Amount / concentration applied:
- The test item was tested as a 20% w/v solution in 0.9% sodium chloride solution.
The formulation was prepared on the day of use and was used approximately 3.5 hours after preparation, not within 2 hours of preparation as specified in the protocol. This deviation from protocol was considered not to have affected the integrity or outcome of the study as the OECD test guideline dose not specify a time period between preparation and use.
A volume of 750 µl of the test item formulation was applied to each of three corneas. - Duration of treatment / exposure:
- A volume of 750 µl of the test item formulation was applied to each of three corneas followed by four hour vertical position incubation at 32°C, with shaking. After this incubation, each cornea was washed and the anterior chambers filled with pre-warmed EMEM (without phenol red) the opacities measured and the anterior chamber emptied. For the permeability endpoint, 1 ml of sodium fluorescein (5 mg/ml solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and held in a labelled tube. Three 350 µl aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490).
A volume of 750 µl of the negative or positive control was similarly applied to further groups of three corneas. These groups were subject to the procedures detailed above. - Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- The study was conducted to meet the known requirements of OECD Guidelines for Testing of Chemicals Method 437 (adopted 7 September 2009).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 151.27
- Negative controls validity:
- valid
- Remarks:
- in vitro irritation score 0
- Positive controls validity:
- valid
- Remarks:
- in vitro irritation score 66.87
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Corneal Opacity:
The corneas treated with the test item were noted to be slightly cloudy. The corneas treated with the positive control were noted to be cloudy.
The mean opacity reading for the test item was 151.3
The mean opacity reading for the negative control was 0.
The mean opacity reading for the positive control was 40.7.
Corneal Permeability:
The mean group corrected optical density for the test item was -0.004.
The mean group corrected optical density for the negative control was 0.
The mean group corrected optical density for the positive control was 1.747.
In Vitro Irritation Score:
The calculated in vitro irritation score for the test item was 151.27
The calculated in vitro irritation score for the negative control was 0.
The calculated in vitro irritation score for the positive control was 66.87.
Any other information on results incl. tables
Corneal Opacity
Test substance |
Cornea number |
Initial opacity |
Post incubation opacity |
Change in opacity |
Mean change in opacity |
Corrected opacity |
Mean corrected opacity |
Test item |
24 |
1 |
160 |
159 |
N/A |
154.3 |
151.3 |
Test item |
30 |
1 |
158 |
157 |
152.3 |
||
Test item |
31 |
1 |
153 |
152 |
147.3 |
||
Negative |
21 |
0 |
11 |
11 |
4.7 |
6.3 |
0.0 |
Negative |
22 |
0 |
1 |
1 |
-3.7 |
||
Negative |
23 |
0 |
2 |
2 |
-2.7 |
||
Positive |
33 |
1 |
43 |
42 |
N/A |
37.3 |
40.7 |
Positive |
34 |
0 |
45 |
45 |
40.3 |
||
Positive |
35 |
1 |
50 |
49 |
44.3 |
Corneal Permeability
Test substance |
Cornea number |
Mean blank OD490 |
OD490 |
Corrected OD490 |
Mean Corrected OD490 |
Final Corrected OD490 |
Mean group Corrected OD490 |
Test item |
24 |
N/A |
0.003 |
0.003 |
N/A |
-0.003 |
-0.004 |
Test item |
30 |
-0.001 |
-0.001 |
-0.006 |
|||
Test item |
31 |
0.002 |
0.002 |
-0.003 |
|||
Negative |
21 |
0.000 |
0.004 |
0.004 |
0.005 |
-0.002 |
0.00 |
Negative |
22 |
0.005 |
0.005 |
0.000 |
|||
Negative |
23 |
0.008 |
0.008 |
0.002 |
|||
Positive |
33 |
N/A |
1.816 |
1.816 |
N/A |
1.810 |
1.747 |
Positive |
34 |
1.492 |
1.492 |
1.487 |
|||
Positive |
35 |
1.949 |
1.949 |
1.944 |
Calculated IVIS
Test substance |
Mean opacity |
Mean permeability |
IVIS (mean opacity + (15 x mean permeability)) |
Negative control |
0 |
0 |
0 |
Positive control |
40.7 |
1.747 |
66.87 |
Test item |
151.3 |
-0.004 |
151.27 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item, Oxypyrion-Acetate, produced an IVIS score of 151.27 and was considered to be corrosive or severely irritating to the eye.
- Executive summary:
This study was conducted to determine whether the test item, Oxypyrion-Acetate (CAS Nr 1742-79-6), causes corrosion or severe irritation to excised bovine corneas using the bovine corneal opacity and permeability (BCOP) assay (OECD guideline 437).
A volume of 750 µl of the test item formulation was applied to each of three corneas followed by a four hour incubation at 32°C. After this incubation, each cornea was washed with media containing phenol red followed by media without phenol red, the opacities measured and then the anterior chamber emptied. For the permeability endpoint, sodium fluorescein solution was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and three 350 µl aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490).
A volume of 750 µl of the negative or positive control was similarly applied to further groups of three corneas. These corneas were subject to the procedures detailed above.
The mean opacity reading for the test article was 151.3, for the negative control was 0 and for the positive control was 40.7.
The mean group corrected optical density for the test article was -0.004, for the negative control was 0 and for the positive control was 1.747.
The test item, Oxypyrion-Acetate, produced an IVIS score of 151.27 and was considered to be corrosive or severely irritating to the eye.
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