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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:
2014-12-10 to 2015-02-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
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
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
yes
Remarks:
Histopathology included
Qualifier:
according to guideline
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
Deviations:
yes
Remarks:
histopathology included
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
butyl 4-hydroxycyclohexanecarboxylate
EC Number:
941-637-2
Cas Number:
1384257-92-4
Molecular formula:
C11H20O3
IUPAC Name:
butyl 4-hydroxycyclohexanecarboxylate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: DRZ22129-058
- Expiration date of the lot/batch: 2015-06-04
- Purity test date: 2014-06-04

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: controlled room temperature (15-25°C), below 70% RH
- Stability under test conditions: yes

Test animals / tissue source

Species:
other: Isolated chicken eyes
Strain:
other: COBB 500
Details on test animals or tissues and environmental conditions:
Source of chicken eyes: Chicken eyes were isolated from chicken heads, which were obtained from a slaughter house
Strain of chicken: COBB 500

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
30 µL of the test item was applied onto the entire surface of the cornea
Duration of treatment / exposure:
The eyes were rinsed with 20 mL physiological saline after an exposure period of 10 seconds from the end of application.
Number of animals or in vitro replicates:
Number of test material treated eyes: 3
Number of positive control treated eyes: 3
Number of negative control eye: 1
Details on study design:
The eye irritating potential of the test item was investigated in isolated chicken's eyes. The test was performed according to OECD TG No. 438.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Remarks:
at up to 75 min [%]
Value:
3.2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
percent corneal swelling
Remarks:
at up to 240 min [%]
Value:
6.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
fluorescein retention score
Value:
1.67
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (26th July 2013). After the zero reference measurements, the eye was held in horizontal position and 30 µL of the liquid test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 µL of 5% (w/v) Benzalkonium chloride solution. The negative control eye was treated with 30 µL of physiological saline (Salsol solution, NaCl 0.9% w/v). Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant. To further establish the classification, histopathological observations were made on two sections of each of the 3 corneas treated with test item (6 sections). Microscopic evaluation showed very slight erosion of the corneal epithelium (6/6). No stromal and endothelial changes were observed as well as no effects on integrity of basement, Bowman’s and Descemet’s membranes. Thus, the test item was categorized as Category 2 (sub-category 2B). Taking a weight of evidence approach, the overall results were categorized as Category 2 (sub-category 2B).

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on th eresults of this test, the test item should be classified as irritating to the eyes and categorized as Category 2 (sub-category 2B).
Executive summary:

see above