butyl 4-hydroxycyclohexanecarboxylate

Eye irritation

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 guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

Irritation parameter:

cornea opacity score

Value:

0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 4

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