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EC number: 205-502-5 | CAS number: 141-79-7
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP Compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437 "Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (adopted 7 September 2009)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Mesityl Oxide
- IUPAC Name:
- Mesityl Oxide
- Reference substance name:
- 4-methylpent-3-en-2-one
- EC Number:
- 205-502-5
- EC Name:
- 4-methylpent-3-en-2-one
- Cas Number:
- 141-79-7
- Molecular formula:
- C6H10O
- IUPAC Name:
- 4-methylpent-3-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): Mesityl Oxide
- Physical state: liquid
- Analytical purity: 99.87%
- Purity test date: 16 April 2010
- Lot/batch No.: A1YB3N010101
- Expiration date of the lot/batch: 16 April 2012
- Storage condition of test material: Ambient condition
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
Eye supply: Slaughter house
Age of animals : 6-12 months
Killing time: Approximately 8:30 to 11:00 in the morning (used in early afternoon).
Transport condition: HBSS 1x plus Penicillin/streptomicin maintained at approximately 4°C.
Approximate test starting time: 13:30
PREARATION OF CORNEAS
- Eyes were examined for the presence of any defects
- Each cornea with 2-3 mm of surrounding sclera was dissected from the eye using a scalpel, scissors and forceps and placed into a Petri dish containing HBSS.
- Each cornea was mounted into a pre-warmed testing chamber with the endothelial surface of the cornea placed in contact with the
O-ring of the posterior part of the chamber.
- The chamber was then filled with EMEM without phenol red maintained at 32 ± 1°C (posterior part of the chamber first to maintain convexity).
EQUILIBRATION OF CORNEAS
- incubation in a liquid bath at 32 ± 1°C at least 1 hour; the two chambers were drained (anterior first) and re-filled with EMEM without phenol maintained at 32 ± 1°C (posterior first).
Selection : Basal opacity of corneas was determined by means of an opacitometer
Corneas were distributed in treatment groups starting from those with minor opacity (maximum basal opacity score: 1).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 corneas for each treatment with the positive or negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml/cornea for 3 corneas
- Concentration (if solution): as supplied
POSITIVE CONTROL
Identity: Sodium hydroxide (NaOH)
Sigma Cat. No. : S5881
CAS : 1310-73-2
Batch no. : 00014227117
Purity: 98.7 %
- Amount(s) applied (volume or weight with unit): 0.75 ml/cornea for 3 corneas
- Concentration: 10% (w/v) solution in water (sterile water Bieffe Medital, batch 08K2901).
NEGATIVE CONTROL
Identity: Physiological saline (0.9% NaCl; Bieffemedital batch no. 07K1701)
- Amount(s) applied (volume or weight with unit): 0.75 ml/cornea for 3 corneas
- Concentration: As supplied - Duration of treatment / exposure:
- Corneas were exposed in horizontal position for 10 minutes incubated in a liquid bath at 32 ± 1°C.
- Number of animals or in vitro replicates:
- 3 corneas for treatment with the test item
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, corneas (epythelial side) were rinsed thoroughly with EMEM with phenol red.
Finally, the anterior chamber was re-filled with EMEM without phenol red maintained at 32 ± 1°C.
- Time after start of exposure: 2 hours in a liquid bath at 32 ± 1°C.
TOOL USED TO ASSESS OPACITY: Opacitometer
PERMEABILITY
- On completion of the opacity measurements, EMEM was removed from both chambers (anterior first).
- The posterior chamber was re-filled with fresh EMEM without phenol red maintained at 32 ± 1°C.
- The anterior chamber (epythelial surface) was treated with 1 ml aliquot of sodium fluorescein solution 0.4% in EMEM without phenol red maintained at 32°C ± 1°C. The fluorescein solution used for treatment was checked for concentration (3.864 mg/ml, using a reference curve 0-20 µg/ml - 96.6% of the theoretical concentration).
- The corneas were horizontally incubated in a liquid bath at 32 ± 1°C for approximately 90 minutes.
- The medium was removed from the posterior chamber (endothelial surface) and the optical density measure.
TOOL USED TO ASSESS OPACITY: Spectrophotometer set at 490 nm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- other: Mesityl oxide
- Time point:
- other: 10 min
- Score:
- 41.2
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- other: positive control
- Time point:
- other: 10 min
- Score:
- 165.4
- Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- other: negative control
- Time point:
- other: 10 min
- Score:
- 0.35
- Irritant / corrosive response data:
- The test item induced a slight increase of the corneal opacity with a mean value equal to 11.0.
At the macroscopic observation the three corneas showed slight opacity.
With reference to the permeability, the permeability of the cornea after treatment with fluorescein was similar to that of positive control (slightly minor) with a mean observed OD490 value equal to 2.0114, thus indicating a significant alteration of corneal barrier.
Negative control gave the expected results.
The positive control induced opacity of the whole cornea surface with a mean increase of the opacity value equal to 133.0. The corneal permeability was also increased with a mean observed OD490 value equal to 2.1587. One of the three values was excluded since the OD490 value, 2.384, was over the upper limit of detection of this experiment (OD490 = 2.360 for a 20 µg/ml fluorescein solution).
Any other information on results incl. tables
Mesityl oxide: ASSESSMENT OF OCULAR SEVERE IRRITATION/CORROSION BOVINE CORNEAL OPACITY/PERMEABILITY (BCOP) ASSAY
Treatment |
|
Opacity |
|
Macroscopic observation |
|
OD490 |
|
|
|
|
|
|
|
N1 |
|
0* |
|
No macroscopic changes |
|
0,002 |
N2 |
|
1 |
|
No macroscopic changes |
|
0,002 |
N3 |
|
0 |
|
No macroscopic changes |
|
0,006 |
|
Mean |
0,3 |
|
|
Mean |
0,0033 |
|
SD |
0,6 |
|
|
SD |
0,0023 |
|
CV % |
200,0 |
|
|
CV % |
69,70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
P1 |
|
140 |
|
Cornea heavily opaque |
|
1,974 |
P2 |
|
126 |
|
Cornea heavily opaque |
|
2,384° |
P3 |
|
134 |
|
Cornea heavily opaque |
|
2,350 |
|
Mean |
133,3 |
|
|
Mean |
2,1620 |
|
SD |
7,0 |
|
|
SD |
0,2659 |
|
CV % |
5,3 |
|
|
CV % |
12,30 |
|
|
|
|
|
|
|
Corrected Mean |
133,0 |
|
Corrected Mean |
2,1587 |
||
(negative control) |
|
|
(negative control) |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A1 |
|
13 |
|
Cornea slightly opaque |
|
2,275 |
A2 |
|
9 |
|
Cornea slightly opaque |
|
1,909 |
A3 |
|
12 |
|
Cornea slightly opaque |
|
1,860 |
|
Mean |
11,3 |
|
|
Mean |
2,0147 |
|
SD |
2,1 |
|
|
SD |
0,2268 |
|
CV % |
18,6 |
|
|
CV % |
11,26 |
|
|
|
|
|
|
|
Corrected Mean |
11,0 |
|
Corrected Mean |
2,0114 |
||
(negative control) |
|
|
(negative control) |
|
||
|
|
|
|
|
|
|
N1-3: Negative control
P1-3 : Positive control
A1-3: Test item
*: value read was -1; it was assumed to be 0 for mean calculation.
°: this value was outside the spectrophotometer range, and thus it is excluded from mean calculation
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information category 2 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008
- Conclusions:
- The treatment with the test item induced a slight effect on corneal opacity and a strong effect on corneal permeability.
According to the criteria stated in the OECD guideline for this test, the test item is not defined as corrosive or severely irritant to the eye.
However, since the calculated IVIS value is near to the threshold of severe irritancy/corrosion, the test item might have an irritating potential in vivo. - Executive summary:
The potential of the test item Mesityl oxide to cause corrosion/severe irritation by using the Bovine corneal opacity and permeability (BCOP) Assay was examined in agreement with OECD guideline no. 437 (adopted 7 September 2009). The test item was tested without any further dilution (being a liquid) on the epithelial surface of three idoneous bovine corneas for an exposure period of 10 minutes and a recovery period of 2 hours. Positive and negative controls [a 10% (w/v) sodium hydroxide (NaOH) solution and physiological saline alone, respectively] were concurrently tested in the same number of replicates at the same treatment volume (0.75 ml). The mean opacity detected at the end of the test item recovery period was 11.0. After the determination of opacity the epithelial surface of every cornea was treated with a 0.4% solution of sodium fluorescein in EMEM for 90 minutes to investigate alteration in permeability. Mean OD490value of the medium from the endothelial surface side was 2.0114 (similar to the positive control mean value of 2.1587). Positive and negative controls gave the expected results, indicating the good functioning of the test system. These results indicate that the test item induces slight changes on corneal opacity and has a strong effect on corneal permeability. The calculatedin vitroirritancy score (IVIS) for the test item is 41.2. According to the criteria stated in the OECD guideline for this test, the test item is not defined as corrosive or severely irritant to the eye. However, since the calculated IVIS value is near to the threshold of severe irritancy/corrosion, the test item might have an irritating potential in vivo.
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