Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
according to
Guideline:
other: EU Methode B.48
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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)