2(3H)-Furanone, dihydro-3-hydroxy-4,4-dimethyl-, (3S)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-03-24 - 2011-03-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data generated according to generally valid testing guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for the Testing of Chemicals: Isolated Chicken Eyes Test Method for Identifying Ocular Corrosives and Severe Irritants. Adopted: 7 Sep 2009. Following OECD 438.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Methode B.48

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(3S)-3-hydroxy-4,4-dimethyloxolan-2-one

EC Number:

626-470-2

Cas Number:

5405-40-3

Molecular formula:

C6H10O3

IUPAC Name:

(3S)-3-hydroxy-4,4-dimethyloxolan-2-one

Details on test material:

Test item name: L-Pantolactone CAS# 5405-40-3
Lot No: HJ 168 (as labeled)
Composition: N.L.T. 98.0%
Homogeneity: Homogenous
Colour / state: Colorless or yellow crystal

Test animals / tissue source

Species:

other: chicken, isolated eyes

Strain:

other: Not applicable, as isolated eyes.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.03 mg per isolated eye

Duration of treatment / exposure:

10 s

Observation period (in vivo):

30 min, 75 min, 120 min, 180 min and 240 min

Number of animals or in vitro replicates:

3 eyes for the test substance

Results and discussion

In vivo

Results

Irritation parameter:

other: corneal opacity

Time point:

other: see "irritant/corrosive response data" and "any other information on results incl. tables"

Reversibility:

other: see "irritant/corrosive response data" and "any other information on results incl. tables"

Remarks on result:

other: see "irritant/corrosive response data" and "any other information on results incl. tables"

Irritant / corrosive response data:

The endponts evaluated were:
1. corneal opacity
2. fluorescein retention
3. adverse morphological effects (if any)

Any other information on results incl. tables

The fluorescein retention and corneal opacity of ICE before treatment:             ICE ID Flurorescein retention score before treatment Corneal opacity before treatment Additional damage Sample -01 0 0 No Sample -02 0 0 No Sample -03 0 0 No Positive control -01 0 0 No Positive control -02 0 0 No Positive control -03 0 0 No Negative control -01 0 0 No                        The fluorescein retention and corneal opacity of ICE after treatment:  ICE ID Flurorescein retention score 30 min after treatment Corneal opacity after treatment 30 min 75 min 120 min 180 min 240 min Sample -01 2 1 1 1 1 1 Sample -02 2 2 2 2 2 2 Sample -03 2 2 2 2 2 2 Positive control -01 3 3 3 3 3 3 Positive control -02 3 2 2 2 2 2 Positive control -03 3 3 3 3 3 3 Negative control -01 0.5 0.5 0.5 0.5 0.5 0.5     Observation of other adverse morphological effect:  No adverse morphological effect was observed in all the seven ICEs during the observation period.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Under the condition of this study, the test item- L-Pantolactone, CAS# 5405-40-3, is not considered
as ocular corrosive or severe irritant using Isolated Chicken Eye Test Method.
The substance is not classified as Eye Dmg - Cat 1 (irreversible effects on the eye).

Efforts are ongoing to further characterize the usefulness and limitations of the ICE test method for identifying non- severe irritants and non-irritants. A Guidance Document on the use of in vitro ocular toxicity test methods is under development.

The conservative classification is: Serious eye damage/eye irritation, cat 2 (GHS), Irritating, Xi, R36 (DPD) until other tests must be taken.

Executive summary:

For test substance, the mean maximum opacity score after treatment is 1.7 (Class III); the mean fluorescein retention score at 30 min after treatment is 2.0 (Class III). No adverse morphological effect was observed during the observation period. Hence, the test substance is not considered as ocular corrosive or severe irritant.

For positive control substance, the mean maximum opacity score after treatment is 2.7 (Class IV); the mean fluorescein retention score at 30 min after treatment is 3.0 (Class IV). The corneal opacity of all the three eyes was >= 2 at 30 min after treatment. Hence, the positive control substance is considered as ocular corrosive or severe irritant.

For negative control substance, the mean maximum opacity score after treatment is 0.5 (Class II); the mean fluorescein retention score at 30 min after treatment is 0.5 (Class I). Hence, the negative control substance is not considered as ocular corrosive or severe irritant.

Expert judgement:

L-Pantlactone has effects on the eyes (opacity score after treatment is 1,7).

It can not be distinguished, if the irritating effects are slightly or moderately.

The substance will be classified as serious eye damage/eye irritation, cat 2 (GHS), Irritating, Xi, R36 (DPD) until other test must be taken.

(Conservative classification)