Diisopentyl ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diisopentyl ether

EC Number:

208-857-4

EC Name:

Diisopentyl ether

Cas Number:

544-01-4

Molecular formula:

C10H22O

IUPAC Name:

3-methyl-1-(3-methylbutoxy)butane

Details on test material:

- Name of test material (as cited in study report): Diisopentyl ether
- Analytical purity: 99.2%
- Lot/batch No.: TAP 625
- Storage condition of test material: 2-8 °C

Test animals / tissue source

Species:

other: in-vitro test

Strain:

other: isolated bovine cornea

Details on test animals or tissues and environmental conditions:

TEST MATERIAL
- Source: slaughterhouse (Muller Fleisch GmbH, Birkenfeld, Germany)
- Acclimation period: the eyes were transported to the test facility in Hank's balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in incubation medium at 32 +/- 1°C in an incubation chamber for 1 hour.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Negative control: physiological sodium chloride solution; positive control: 10% sodium hydroxide solution.

Amount / concentration applied:

An amount of 750 µl diisopentyl ether was applied directly on the corneas in such a way that the cornea was completely covered.

Duration of treatment / exposure:

The corneas were incubated in a horizontal position for 10 minutes at 32°C.

Observation period (in vivo):

Not applicable, the effects on the corneas was determined directly after the exposure period.

Number of animals or in vitro replicates:

Not applicable (in vitro study)

Details on study design:

The aim of this study was to evaluate the ocular irritancy of diisopentyl ether as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea.

PROTOCOL
- For each treatment group (negative control, positive control and test item), three replicates were used.
- The opacity of each cornea was determined before exposure.
- The corneas were exposed for 10 minutes.
- After the incubation the change in opacity for each individual cornea (including the negative control) was determined.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated.

INTERPRETATION
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score (IVIS) that falls within two standard deviations of the laboratory historical mean value.
- The negative control response has to show an IVIS between 0 and 3.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro irritancy score (IVIS)
- A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.

Results and discussion

In vivo

Results

Irritation parameter:

other: The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score.

Remarks on result:

other: Diisopentyl ether did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.0080 after 10 minutes of treatment.

Irritant / corrosive response data:

The negative control showed no irritation (mean IVIS was 0.443). The positive control induced a very severe irritation on the cornea, mean IVIS was 195.5. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The mean in vitro irritancy score of the test item was 0.008 after 10 minutes of treatment with diisopentyl ether. For this reason it can be concluded that diisopentyl ether is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Diisopentyl ether is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test.

Executive summary:

A GLP compliant in-vitro study was performed according to OECD Guideline 437 in order to evaluate the ocular irritation properties of diisopentyl ether on an isolated bovine cornea. The possible ocular irritancy of diisopentyl ether was tested through topical application for approximately 10 minutes. For each treatment group (negative control, positive control and test item), three replicates were used. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

After treatment, the IVIS (in vitro irritancy score) in the controls is within the acceptability criterion. The positive control showed clear irritating effects. Diisopentyl ether showed no effects on the cornea of the bovine eyes. The IVIS score is 0.008 and therefore it can be concluded that diisopentyl ether is not an eye irritant in the BCOP Test.