Octadecan-1-ol, ethoxylated, phosphates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 October 2018 to 30 August 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecan-1-ol, ethoxylated, phosphates

EC Number:

500-155-9

EC Name:

Octadecan-1-ol, ethoxylated, phosphates

Cas Number:

62362-49-6

Molecular formula:

Variable

IUPAC Name:

Octadecan-1-ol, ethoxylated, phosphates

Specific details on test material used for the study:

Purity: 100% (UVCB)
Appearance/Physical state: Solid, white pastille
Storage: Room temperature in the dark

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.

Test system

Vehicle:

other: For the purpose of this study the test item was prepared as a 10% w/v solution in sodium chloride 0.9% w/v.

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

For the purpose of this study the test item was prepared as a 10% w/v solution in sodium chloride 0.9% w/v.

The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.

No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Duration of treatment / exposure:

The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the formulated test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 +/- 1 deg.C for 10 minutes.

Duration of post- treatment incubation (in vitro):

At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. A post treatment opacity reading was taken and each cornea was visually observed.

The holders were incubated, anterior chamber facing forward, at 32 +/- 1 deg.C for 120 minutes.

Number of animals or in vitro replicates:

Three

Details on study design:

The test item, a surfactant solid, was applied at a concentration of 10% w/v in sodium chloride 0.9% w/v for 10 minutes followed by an incubation period of 120 minutes. Negative (Sodium Chloride 0.9% w/v) and positive (Ethanol) 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).

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Run / experiment:

1

Value:

ca. 2.6

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The corneas treated with the test item were clear post treatment. The corneas treated with the negative control item were clear post treatment. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the Bovine Corneal Opacity and Permeability (BCOP) test, the test item is not an irritant to the eye. No category was assigned and the test item does not require classification under UN GHS or EU CLP.

Executive summary:

The purpose of this test was to identify the potential for the test item, Octadecan-1-ol, ethoxylated, phosphates (CAS RN 62362-49-6), to induce serious eye damage and to determine whether the test item requires classification for eye irritation or serious eye damage. The Bovine Corneal Opacity and Permeability (BCOP) test method is an organotypic model that provides short‑term maintenance of normal physiological and biochemical function of the bovine corneain vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability.

The test method can correctly identify test items (both chemicals and mixtures) inducing serious eye damage as well as those not requiring classification for eye irritation or serious eye damage, as defined by the United Nations (UN) Globally Harmonized System of Classification and Labelling of Items (GHS) and EU Classification, Labelling and Packaging (CLP) of chemicals (Regulation (EC) No 1272/2008), and it was therefore endorsed as scientifically valid for both purposes. Test items inducing serious eye damage are classified as UN GHS and EU CLP Category 1. Items not classified for eye irritation or serious eye damage are defined as those that do not meet the requirements for classification as UN GHS/EU CLP Category 1 or 2 (2A or 2B), i.e. they are referred to as UN GHS/EU CLP No Category.

The test item, a surfactant solid, was applied at a concentration of 10% w/v in sodium chloride 0.9% w/v for 10 minutes followed by an incubation period of 120 minutes. Negative (Sodium Chloride 0.9% w/v) and positive (Ethanol) 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 anIn VitroIrritancy Score (IVIS). 

Based on the results of theBovine Corneal Opacity and Permeability (BCOP)test, the test item,Octadecan-1-ol, ethoxylated, phosphates (CAS RN 62362-49-6), is not an irritant to the eye. No category was assigned and the test item does not require classification under UN GHS or EU CLP.