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Diss Factsheets

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:
2021-09-22 to 2021-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
adopted 25 June 2018
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
EC Number:
942-548-1
Molecular formula:
(CnH2n-102/Cn’H2n’-1O2) Co with n, n’ = 2 or 8 or 20
IUPAC Name:
Salt reaction of cobalt(2+) and C2/C8/C20 carboxylates
Test material form:
solid: pellets

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
30 mg of the test item was applied, after being reduced to fine powder, and under fume hood, for 10 seconds to the cornea such that the entire surface of the cornea was evently covered with the test item. Then the eyes were rinsed twice wiith 10 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° C0543A01) and positive control (sodium hydroxide - Fisher Scientific - batch n° 00000) were included in this experiment. One eye was treated with 30 µL of negative control and three eyes were treated with 30 mg of positive control. Then, the controls underwent the entire testing procedure.
Duration of post- treatment incubation (in vitro):
All observations of the cornea and measurement of corneal thickness were performed using a Haag-Streit BP900 slit-lamp microscope with depth-measuring device n° I. For the measurement of corneal thickness, the slit-width was set at 9½ equalling 0.095 mm.
Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 45 min pre-treatment
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 75 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 120 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 180 min
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 240 min
Irritation parameter:
fluorescein retention score
Remarks:
mean
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 45 min pre-treatment
Irritation parameter:
fluorescein retention score
Remarks:
mean
Value:
2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
11
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 30 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
11
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 75 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
13
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 120 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
13
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 180 min
Irritation parameter:
percent corneal swelling
Remarks:
mean
Value:
13
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: time = 240 min
Other effects / acceptance of results:
The ocular reactiond observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.5, corresponding to ICE class I;
- mean score of fluorescein retention: 2.0, corresponding to ICE class III;
- maximal mean corneal swelling: 13%, corresponding to ICE class II.
The combination of the three endpoints for the test item was 1 x I, 1 x III, 1 x II.

Any other information on results incl. tables

The combination of the 3 endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.

The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control is classified as 'No category' as expected.

Applicant's summary and conclusion

Interpretation of results:
other: No prediction can be made.
Conclusions:
In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions lead to the category 'No prediction can be made' as defined by the O.E.C.D. test guideline n° 438. Therefore, the test item is not predicted as causing sever eye damage (Caetegory) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing is required to establish a definitive classification.