[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Principles of method if other than guideline:

The physical form of the test material was a solid block. The melting point would be too high for testing in the BCOP assay and also water solubility was indicated as null suggesting that solubilising in 0.9% sodium chloride would not be possible.
Therefore in accordance with the methods described within the OECD BCOP test guideline, the test material was ground and applied neat onto the corneal surface. The cornea was exposed to the neat test item for 4 hours. The weight of the test item that adequately covered the epithelial
surface was determined. The ‘open-chamber’ method was adopted. Following application the ring & glass were replaced during the exposure period until rinsing. Rinsing was performed as the standard procedure.
These deviations were considered not to affect the purpose or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Molecular formula:

R1-NH-C=O-R2, with R1=C16H33 and C18H37 & R2 = C15H31 and C17H35

IUPAC Name:

Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Test material form:

solid

Details on test material:

- Chemical registery number : 955-212-4
- Chemical name: Amides, C16-18 (even numbered), N-C16-18 (even numbered) alkyl

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

Test animals / tissue source

Species:

other: bovine

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Test System:
Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee and placed in Hanks’ Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, and transported to the laboratory on ice packs. The corneas were prepared immediately on arrival.
Test Material:
For the purpose of this study the test material was used as supplied. The physical form of the test item was a solid block. The melting point would be too high for testing in the BCOP assay and also water solubility was indicated as nil suggesting that solubilising in 0.9% sodium chloride would not be possible. The test material was therefore ground and applied to the cornea for 4 hours as described in the OECD BCOP testing guideline.

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

Neat substance

Controls:

not specified

Amount / concentration applied:

300 mg

Duration of treatment / exposure:

240 minutes

Details on study design:

Preparation of Corneas:
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed (epithelial side uppermost) in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete minimum essential medium (MEM) and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
The MEM was removed from the anterior chamber of the BCOP holder and the test item or control items applied to the corneal surface. 300mg of the ground neat test material was found to adequately cover the cornea. 750µL of each control item was applied to the appropriate corneas.
The holders were gently tilted back and forth to ensure a uniform application over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1ºC for 240 minutes.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

1.1

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered not to be an ocular corrosive or severe irritant.

Executive summary:

A study was performed to assess the ocular irritancy potential of the test item to the isolated bovine cornea. The method was designed to be compatible with the OECD Guidelines for the Testing of Chemicals No. 437 (2009) "Bovine Corneal Opacity and Permeability Assay.

The test item was applied neat for 240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).

A test item that induces an In Vitro Irritancy Score 55.1 is defined as an ocular corrosive or severe irritant.

The following IVIS were obtained:
Test Item 1.1
Negative Control 5.3
Positive Control 86.6

The test item was considered not to be an ocular corrosive or severe irritant.