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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:
30 November 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study following OECD Guideline 437 with no deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
other: isolated bovine cornea
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Eyes from freshly slaughtered adult cattle as a by-product of normal operation
- Age at study initiation: 12-60 months

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% w/v of test item in 0.9% w/v sodium chloride solution

VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 0.9% w/v sodium chloride solution
Duration of treatment / exposure:
240 minutes
Observation period (in vivo):
At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
At the end of the exposure period the test item preparation and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. The anterior and posterior chambers were refilled with fresh complete MEM. A post-treatment opacity reading was taken and each cornea was visually observed. The corneas were visually observed for macroscopic damage (eg pitting/sloughing) caused by the test item or controls.
Number of animals or in vitro replicates:
3 corneas per test item, positive control, and vehicle
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed 3 times with fresh minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM
- Time after start of exposure: 240 minutes

Scoring system: results from the two endpoints were combined to generate an In Vitro Irritancy score.
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
A test item that induces an In Vitro Irritancy score >= 55.1 is considered on ocular corrosive or severe irritant.

TOOL USED TO ASSESS SCORE: Opacitometer/ fluorescein

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
60.7
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The positive control In Vitro Irritancy Score was within the range of 55.8 to 126.1. The positive acceptance criterion was therefore satisfied.
The corneas treated with the negative control item was clear post incubation (In Vitro Irritancy Score: 3.1).

In vivo

Irritant / corrosive response data:
In Vitro Irritancy score - test item: 60.7
In Vitro Irritancy score-negative control: 3.1, clear
In Vitro Irritancy score-positive control: 81.6. (Historical range 55.8-126.1, acceptable), cloudy

Any other information on results incl. tables

In Vitro Irritancy score - test item: 60.7

In Vitro Irritancy score-negative control: 3.1, clear

In Vitro Irritancy score-positive control: 81.6. (Historical range 55.8-126.1, acceptable), cloudy

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found to be an ocular corrosive or severe irritant (In Vitro Irritancy score >/= 55.1).