9-Octadecen-1-ol, (Z)-, phosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-12-05 to 2012-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to GLP, OECD and EC guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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)

Version / remarks:

adopted 07 September 2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EU) No 1152/2010 of 08 December 2010 amending, Regulation (EC) No 440/2008 (REACH) B.48

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

UVCB: not applicable

IUPAC Name:

UVCB: not applicable

Constituent 2

Reference substance name:

UVCB: not applicable

IUPAC Name:

UVCB: not applicable

Constituent 3

Reference substance name:

9-Octadecen-1-ol, (Z)-, phosphate

EC Number:

253-455-4

EC Name:

9-Octadecen-1-ol, (Z)-, phosphate

Cas Number:

37310-83-1

Molecular formula:

C18H37O4P

IUPAC Name:

[(9Z)-octadec-9-en-1-yloxy]phosphonic acid

Test material form:

liquid: viscous

Test animals / tissue source

Species:

other: not applicable: Isolated chicken eyes (ROSS 308)

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

Chicken heads collection and transport
Species of chicken: ROSS 308
Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129. Hungary
The age and weight of the chickens used for this study were that of spring chickens traditionally processed by a poultry slaughterhouse
(i.e., approximately 7 weeks old, 1.5 – 2.5 kg). Head collection was performed by a slaughter house technician. The heads were transported to TOXI-COOP ZRT. at the earliest convenience for use approximately within 2 hours from collection. All eyes used in the assay were from the same groups of eyes collected on one specific day. After collection, the heads were inspected for appropriate quality and wrapped with paper moistened with saline, then placed in a plastic box that can be closed (4-5 heads/box).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: not applicable; however, eyes for positive and negative control were used

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 g
Test item was spread evenly on a small piece (approximately 2 cm2) of flexible plastic film to be applied directly onto the cornea.

Duration of treatment / exposure:

After carefully covering the whole cornea with the test substance an exposure period of 10 seconds was applied.
Subsequently, the plastic film was removed from surface of the cornea carefully, taking care not to damage or touch the cornea with the application
equipment.

Observation period (in vivo):

The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Minor variations within ±5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the posttreatment rinse.

Number of animals or in vitro replicates:

The treatment group and the concurrent positive control consisted of three eyes. The negative control group consisted of one eye.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: cornea surface was rinsed thoroughly with 20 mL saline solution at ambient temperature,
- Time after start of exposure: 10 seconds

SCORING SYSTEM:
Evaluation:
The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological effects (e.g., pitting or loosening of the epithelium).
Results from corneal opacity, swelling, and fluorescein retention were evaluated separately to generate an Isolated Chicken Eye (ICE) class for each
endpoint. The ICE classes for each endpoint were then combined to generate an Irritancy Classification for each test substance (regulatory EC/GHS
classification).
Severity of effects:
The effects were divided into four categories:
I = none
II = slight
III = moderate
IV = severe O

TOOL USED TO ASSESS SCORE: The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was measured on
two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Value:

4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

fluorescein retention score

Value:

3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

percent corneal swelling

Remarks:

at up to 75 min

Value:

1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

percent corneal swelling

Remarks:

at up to 240 min

Value:

2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

In vivo

Results

Results 1

Irritation parameter:

other: corneal opacity score

Basis:

mean

Remarks:

ìsolated chicken eyes

Time point:

other: 30-75-120-180-240 min relative observation time

Score:

4

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

other: corneal thickness

Basis:

mean

Remarks:

isolated chicken eyes

Time point:

other: 30-75-120-180-240 min relative observation time

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: The values are given in "% change of instrumental units in comparison to timepoint 0"

Results 3

Irritation parameter:

other: fluorescein retention

Basis:

mean

Remarks:

isolated chicken eyes

Time point:

other: 30 min relative observation time

Score:

3

Max. score:

3

Reversibility:

other: not applicable

Irritant / corrosive response data:

In this in vitro eye irritation study using the isolated chicken eyes test with Reaction product of oleyl alcohol with polyphosphoric acid, ocular
corrosion and severe irritation potential was observed. The test item was classified as corrosive/severely irritating, CLP Classification: Category 1.

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this In vitro eye corrosives and severe irritants study, using the Isolated Chicken Eyes model with Reaction product of oleyl alcohol with poly-
phosphoric acid, according to the guideline OECD 438 ocular corrosion and severe irritation potential was observed. Thus, according to Regulation (EC) No 1272/2008 Reaction product of oleyl alcohol with polyphosphoric acid causes serious damage to the eye and has to be classified into
Category 1.

Executive summary:

In this In vitro eye corrosives and severe irritants study, using the Isolated Chicken Eyes model with Reaction product of oleyl alcohol with poly- phosphoric acid, according to the guideline OECD 438 ocular corrosion and severe irritation potential was observed. Thus, according to Regulation (EC) No 1272/2008 Reaction product of oleyl alcohol with polyphosphoric acid causes serious damage to the eye and has to be classified into Category 1.