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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:
07 December 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
Deviations:
no
Qualifier:
according to
Guideline:
other: EU Method B.47 “Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 40854/A TE
- Physical state: Reddish-brown powder
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Hygroscopic: Yes, store in well-sealed container

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 293 to 317 mg per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole


Duration of treatment / exposure:
240 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vivo

Results
Irritation parameter:
other: In vitro irritancy score (IVIS)
Basis:
mean
Time point:
other: 240 minutes
Score:
19

Any other information on results incl. tables

The mean permeability of the negative control group was not within the laboratory historical control data range. Evaluation: The mean in vitro irritancy score of the negative control group was within the historical control data range. In addition the positive control group was within the acceptability criteria of the assay. Therefore this deviation has no impact on the study integrity.

Applicant's summary and conclusion

Conclusions:
The in vitro eye irritation test was conducted according to OECD 437 guideline and GLP principles.
FAT 40854/A TE is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test

Executive summary:

FAT 40854/A TE was tested in the in vitro eye irritation test according to OECD guideline 437 and GLP principles.

The mean in vitro irritancy score of the negative control was within the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. Although the mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 82 and was outside the historical positive control data range, it was within the acceptability criteria of the assay (mean in vitro irritancy score was within two standard deviations of the laboratory historical mean value). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

FAT 40854/A did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 19 after 240 minutes of treatment. As a result, FAT 40854/A TE is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test.