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EC number: 208-793-7 | CAS number: 541-85-5
- 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
- Remarks:
- other: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.03.2013-28.03.2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully documented study run under GLP and according to international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: guideline OECD 437 “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-methylheptan-3-one
- EC Number:
- 208-793-7
- EC Name:
- 5-methylheptan-3-one
- Cas Number:
- 541-85-5
- Molecular formula:
- C8H16O
- IUPAC Name:
- 5-methylheptan-3-one
- Details on test material:
- - Name of test material: Ethylamylketon, CAS Nr: 541-85-5
- Lot/batch No.: Ref. No. 12023305
- Expiration date of the lot/batch: 31. May 2013
- Storage condition of test material: The test item was stored in a tightly closed container in a well ventilated place, dry at room temperature.
Constituent 1
Test animals / tissue source
- Species:
- other: bovin cornea
Results and discussion
In vivo
Results
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Time point:
- other: -
- Score:
- 0.17
- Max. score:
- 80
- Reversibility:
- not reversible
Any other information on results incl. tables
Table1-a Absorption and Opacity Values Negative Control and the Positive Control
Parameter |
Negative control |
Positive control |
||||
Absorption before exposition |
0.1577 |
0.1403 |
0.1431 |
0.1331 |
0.1310 |
0.1389 |
Absorption after exposition |
0.1943 |
0.1981 |
0.2307 |
2.0127 |
2.0430 |
2.0892 |
Opacity before exposition |
1.4378 |
1.3813 |
1.3903 |
1.3586 |
1.3521 |
1.3769 |
Opacity after exposition |
1.5642 |
1.5780 |
1.7010 |
102.9675 |
110.4079 |
122.8005 |
Opacity Difference |
0.1264 |
0.1966 |
0.3107 |
101.6088 |
109.0558 |
121.4236 |
Table1-b Absorption and Opacity Values Test Item and Solvent control
Parameter |
Test ItemEthylamylketon |
Solvent control |
||||
Absorption before exposition |
0.1590 |
0.1614 |
0.2311 |
0.1774 |
0.1242 |
0.1350 |
Absorption after exposition |
0.2065 |
0.2099 |
0.3419 |
0.2117 |
0.1899 |
0.2363 |
Opacity before exposition |
1.4421 |
1.4501 |
1.7026 |
1.5045 |
1.3311 |
1.3646 |
Opacity after exposition |
1.6088 |
1.6214 |
2.1974 |
1.6282 |
1.5485 |
1.7231 |
Opacity Difference |
0.1667 |
0.1713 |
0.4948 |
0.1236 |
0.2174 |
0.3585 |
Table1-c Optical density at 490 nm Negative Control and Positive Control
Repl. |
Negative Control |
Positive Control |
||||
Meas. |
0.0105 |
0.0099 |
0.0102 |
0.8435 |
0.6925 |
0.7355 |
Corr. |
0.0525 |
0.0495 |
0.0510 |
4.2175 |
3.4625 |
3.6775 |
Mean |
0.0510 |
-- |
Table 9.1-d Optical density at 490 nm Test Item and Solvent Control
Repl. |
Solvent control |
Test Item |
||||
Meas. |
0.0096 |
0.0081 |
0.0108 |
0.0070 |
0.0129 |
0.0136 |
Corr. |
0.0480 |
0.0405 |
0.0540 |
0.0350 |
0.0645 |
0.0680 |
Mean |
0.0475 |
|
Table2 IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
0.914 |
0.976 |
8.9 % |
0.939 |
|||
1.076 |
|||
Solvent control |
0.844 |
0.946 |
20.4 % |
0.825 |
|||
1.168 |
|||
Test Item |
-0.254 |
0.169 |
243.8 % |
0.193 |
|||
0.569 |
|||
Positive Control |
163.895 |
166.507 |
4.9 % |
160.017 |
|||
175.610 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: other: Criteria defined in "Bovine Corneal Opacity and Permeability (BCOP) Assay", SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997; Gautheron et al. (1992) refined by Vanparys et al. (1994)
- Conclusions:
- The test item Ethylamylketon (5-methylheptan-3-one) is non corrosive in the eye according to Regulation (EC) 1272/2008.
- Executive summary:
Corrosivity in the eye of ethylamylketone (5-methylheptan-3-one) was tested according to the OECD 437 guideline under GLP. One valid experiment was performed.
The test item ethylamylketone (5-methylheptan-3-one) was tested as 10 % solution in olive oil. The solution was brought onto the cornea of a bovine eye which had been incubated with cMEM without Phenol red at 32±1°C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32±1°C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Physiological sodium chloride solution was used as negative control, olive oil was used as solvent control, sodium hydroxide (10 % solution in 0.9 % sodium chloride solution) was used as positive control.
The positive control induced a very severe irritation on the cornea, while the negative control and the solvent control showed no irritation.
The test item was tested as 10 % solution in olive oil. A mean IVIS of 0.169 was calculated, corresponding to an ICCVAM classification as not eye irritant. According to OECD Guideline no. 437 (2009), a substance that induces an IVIS = 55.1 is defined as a corrosive or severe irritant. Therefore, ethylamylketone (5-methylheptan-3-one) is “not corrosive” resp. “no severe irritant”.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item ethylamylketone (5-methylheptan-3-one) is not classified as corrosive to the eye (H318) according to Regulation (EC) 1272/2008.
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