5-methylheptan-3-one

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:

2013

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

Test material information

Constituent 1

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.

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 0.9 % NaCl	0.914	0.976	8.9 %
	0.939
	1.076
Solvent control Olive oil	0.844	0.946	20.4 %
	0.825
	1.168
Test Item Ethylamylketon	-0.254	0.169	243.8 %
	0.193
	0.569
Positive Control 10 % NaOH	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.