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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Feb. 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern guideline conform study performed in GLP certified laboratory

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: YELLOW LF 6881
Batch number: RW 2013-10-22
Form: Powder
Color: Orange
Storage conditions: Room temperature
Expiring date: 22. 10. 2018

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
YELLOW LF 6881 was applied in a volume of 0.03 g by powdering the entire surface of the cornea of isolated chicken eyes
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Number of animals or in vitro replicates:
Three test item treated eyes, three positive control eyes and one negative control eye were used in this study
Details on study design:
Three test item treated eyes were treated with Yellow LF 6881 in a volume of 0.03 g by powdering the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance
The three positive control eyes were treated in a similar way with 0.03 g Imidazole.
One negative control eye was treated with 30 µL saline solution.
After an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with ~20 mL saline solution at ambient temperature and this procedure was repeated for each eye.

Results and discussion

In vivo

Irritant / corrosive response data:
In this in vitro eye irritation study using the isolated chicken eyes test with YELLOW LF 6881, no ocular corrosion or severe irritation potential was observed. The test item was not a severe irritant.
Based on the overall in-vitro classification no prediction can be made for the UN, GHS classification.

Any other information on results incl. tables

The mean values of the treated eyes for maximum corneal thickness change, corneal opacity, fluorescein retention and other observation (morphological effect etc.) are given below.

Test Item: YELLOW LF 6881

Observation Value ICE Class1

Mean maximum corneal swelling at up to 75 min 2 % I

Mean maximum corneal swelling at up to 240 min 3 % I

Mean maximum corneal opacity 0.7 II

Mean fluorescein retention 1.2 II

Other Observations The test item was stuck on the cornea surfaces at 30 minutes after the post-treatment rinse. The cornea surfaces were totally cleared at 75 min after the post-treatment rinse.

Overall ICE Class1 1xI, 2xII

In this in vitro eye irritation study using the isolated chicken eyes test with YELLOW LF 6881, no ocular corrosion or severe irritation potential was observed. The test item was not a severe irritant.

Positive Control: Imidazole

Observation Value ICE Class1

Mean maximum corneal swelling at up to 75 min 17 % III

Mean maximum corneal swelling at up to 240 min 28 % III

Mean maximum corneal opacity 4.0 IV

Mean fluorescein retention 2.8 IV

Other Observations Cornea opacity score 4 was observed in three eyes at 30 minutes after the post-treatment rinse.

Overall ICE Class1 1xIII, 2xIV

The positive control Imidazole was classed as corrosive/severely irritating, UN GHS Classification: Category 1.

Negative Control: NaCl (9 g/L saline)

Observation Value ICE Class1

Mean maximum corneal swelling at up to 75 min 0 % I

Mean maximum corneal swelling at up to 240 min 0 % I

Mean maximum corneal opacity 0.0 I

Mean fluorescein retention 0.0 I

Other Observations None

Overall ICE Class1 3xI

The negative control NaCl (9g/L saline) had no significant effects on the chicken eye in this study.

Positive and negative control values were within the corresponding historical control data ranges.

Applicant's summary and conclusion

Interpretation of results:
other: no prediction can be made
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
In this ICET, YELLOW LF 6881 did not cause ocular corrosion or severe irritation in the enucleated chicken eyes.
Positive and negative controls showed the expected results. The experiment was considered to be valid.
Thus, according to the guideline OECD 438, YELLOW LF 6881 cannot be classified as an ocular corrosive or severe eye irritant.
Executive summary:

In this ICET, YELLOW LF 6881 did not cause ocular corrosion or severe irritation in the enucleated chicken eyes.

Positive and negative controls showed the expected results. The experiment was considered to be valid.

As no ocular corrosion or severe irritation potential was observed this in vitro eye corrosives and severe irritants study, using the Isolated Chicken Eye model with YELLOW LF 6881, according to the guideline OECD 438, YELLOW LF 6881 cannot be classified as an ocular corrosive or severe eye irritant.