(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in full compliance with OECD 437 testing guideline and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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:

(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one

EC Number:

201-210-7

EC Name:

(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one

Cas Number:

79-50-5

Molecular formula:

C6H10O3

IUPAC Name:

(±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one

Constituent 2

Reference substance name:

RS-Pantolactone

IUPAC Name:

RS-Pantolactone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): RS-Pantolactone
- Analytical purity: 99.8%
- Lot/batch No.: Bx TL 00905003
- Expiration date of the lot/batch: June 30, 2011

Test animals / tissue source

Species:

other: bovine cornea

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Concentration: 20% in saline
- Amount: 0.75 mL

CONTROLS:
- Concentration (negative control): pure saline
- Concentration (positive control): 10% (w/v) Benzalconium chloride in saline
- Amount: 1.0 mL

Duration of treatment / exposure:

240 minutes (± 5 minutes)

Number of animals or in vitro replicates:

3 corneae per group (test item, negative & positive control)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): by replacing the test & control solutions by fresh cMEM

TOOL USED TO ASSESS SCORE:
1) Opacity measurement (Opacitometer)
2) Permeability (Incubation with Na-fluorescein solution for 90 minutes; OD measurement of the posterior compartment at 490 nm)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

16.07

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

In vivo

Results

Results 1

Irritation parameter:

other: in vitro irritation score (IVIS)

Basis:

mean

Score:

0.13

Reversibility:

not specified

Remarks on result:

other: negative control

Results 2

Irritation parameter:

other: in vitro irritation score (IVIS)

Basis:

mean

Score:

124.56

Reversibility:

not specified

Remarks on result:

other: positive control

Results 3

Irritation parameter:

other: In vitro irritation score (IVIS)

Basis:

mean

Score:

16.07

Reversibility:

not specified

Remarks on result:

other: Test item

Any other information on results incl. tables

Test group	Opacity value		Permeability		In vitro score	Mean in vitro score	Proposed in vitro irritation scale (INVITTOX classifiaction)
		Mean		Mean
Negative control	0	-0.67	0.050	0.053	0.76	0.13	Non eye irritant
	0		0.049		0.73
	-2		0.060		-1.10
Positive control	155.67	123.00	0.117	0.104	157.42	124.56	Very severe eye irritant
	112.67		0.160		115.06
	100.67		0.036		101.20
20% RS-Pantolactone in saline	6.67	13.00	0.116	0.204	8.41	16.07	Mild eye irritant
	14.67		0.187		17.47
	17.67		0.310		22.32

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the results of this study, the test item RS-Pantolactone is not to be classified as Eye Damage Category 1 according to UN GHS.
Based on the results of this study, the test item RS-Pantolactone is not to be classified as Not Classified according to UN GHS.

Executive summary:

A Bovine Corneal Opacity and Permeability Test (BCOP) has been performed on the test item RS-Pantolactone. The test has been performed in compliance with the OECD 437 guideline and under GLP.

The test item produced a mean in vitro irritation score (IVIS) of 16.07. Appropriate positive and negative controls, which were carried along in parallel, behaved as expected.

Based on the classification criteria as in the current OECD 437 guideline (2013) and in UN GHS, the test item RS-Pantolactone is to be classified neither as Eye Damage Category 1 nor as Not classified.

Being not corrosive to the eye but producing a distinct effect in this BCOP assay, is highly likely that the test item RS-Pantolactone can be considered as eye irritant.