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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-02-28 to 2017-06-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
adopted 26 July 2013
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
dated 27 April 2017

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromium tris((2-ethylhexanoate)
EC Number:
222-357-3
EC Name:
Chromium tris((2-ethylhexanoate)
Cas Number:
3444-17-5
Molecular formula:
Cr(C8H16O2)3
IUPAC Name:
chromium(3+); 2-ethylhexanoate
Test material form:
other: Solid/paste

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
The test item was applied, on three gauzes (0.481g, 0.474g, and 0.508g) in order to cover the entire surface of the cornea. The gauzes were subsequently applied to 3 unucleated chicken eyes during 10 seconds such that the entire surface of the cornea was evenly covered with the test item. Then the eyes were rinsed twice with 10 mL of physiological saline at ambient temperature.
Concurrent negative control (physiological saline - Dutscher batch n° 3012316) and positive control (sodium hydroxide - Sigma batch n° MKBP7805V) were included in this experiment. One eye was treated with the negative control and three eyes were treated with the positive control.
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 chicken eyes for main test, 1 chicken eye for negative control and 3 chicken eyes for positive control

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 = 0 min
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
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
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:
0.2
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:
0.2
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 = 0 min
Irritation parameter:
fluorescein retention score
Remarks:
mean
Value:
1
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:
0
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:
1
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:
1
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:
1
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:
1
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:
Test item - Chromium 2-ethylhexanoate:
Corneal opacity: maximal mean score = 0.2 at 240 min corresponding to ICE class I
Fluorescein retention: maximal mean score = 1.0 at 30 min corresponding to ICE class II
Corneal swelling: maximal mean = + 1% at 240 min corresponding to ICE class I
Combination of the 3 endpoints: 2 x I, 1 x II

Positive control:
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.

Negative control:
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:
GHS criteria not met
Conclusions:
In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category). No signal word and hazard statement are required.