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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:
2015-05-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to
Guideline:
other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: bovine
Details on test animals or tissues and environmental conditions:
- Freshly isolated bovine cornea (at least 9 month old donor cattle)
- Source: Schlachthof Bensheim, 64625 Bensheim, Germany

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: undiluted
Duration of treatment / exposure:
10 min
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
3 cornea per substance

Results and discussion

In vivo

Results
Irritation parameter:
other: IVIS
Basis:
mean
Time point:
other: 10 min
Score:
0.23
Reversibility:
other: not applicable
Remarks on result:
other: BCOP test result

Any other information on results incl. tables

Results after 10 min incubation time

Test group

Opacity value = Difference (t130-t0) of Opacity

Permeability at 490 nm (OD490)

IVIS

Mean IVIS

Proposed in vitro Irritancy Score

 

 

Mean

 

Mean

 

 

 

Negative control

-1

-0.33

0.082

0.068

0.23

0.69

Not categorized

0

0.065

0.98

0

0.058

0.87

Positive control

55.33

1.348

70.55

79.37

Category 1

67.33

1.395

88.25

53.33

1.731

79.25

Test item

0.33

0

0.33

0.23

Not categorized

0.33

-0.006

0.24

0.33

-0.014

0.12

Opacity and permeability values of positive control and the test substance are shown as corrected values.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
From the results of the in vitro BCOP study it was concluded that the test substance is not to be categorized.
Executive summary:

An in vitro study with fresh bovine cornea was conducted according to OECD 437 to investigate the eye irritation properties of the test substance. After a first opacity measurement of the fresh bovine corneae (t0), the neat test item, the positive and the negative controls were applied to corneae and incubated for 10 minutes at 32 ± 1 °C. After the incubation phase the substances were rinsed from the corneae. The corneae were incubated for another 120 minutes at 32 ± 1 °C in incubation medium, and opacity was measured a second time (t130). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 0.69). The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 79.37) corresponding to a classification as serious eye damaging (CLP Cat 1). The test item was tested undiluted. Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean IVIS was 0.23 (threshold for serious eye damage: IVIS55). According to OECD 437 the test item is not categorized.