2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-05-26 to 2016-06-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted October 02, 2012

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted May 30, 2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

EC Number:

500-336-2

EC Name:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid

Cas Number:

157348-58-8

Molecular formula:

Exact identification is not feasible

IUPAC Name:

Copolymer of neodecanoic acid oxiranylmethyl ester and phosphorous acid

Test material form:

other: Colourless, viscous liquid

Details on test material:

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid manufactured by Evonik Degussa GmbH, Batch 1524201 of 2015-12-22.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Species / Strain: Rabbit / New Zealand White
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Sex: male
- Age: Approx. 3 months
- Weight at study initiation: Animal no. 1: 2.6 kg
- Housing: single
- Diet: ad libitum, Commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany,
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: identical animal, second eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: identical animal, left eye

Amount / concentration applied:

Amount: 0.1 mL of the test item was administered to the right eye of one animal.

Duration of treatment / exposure:

Single administration into the conjunctival sac of the right eye

Observation period (in vivo):

24 hours

Number of animals or in vitro replicates:

1 male rabbit

Details on study design:

ADMINISTRATION:
The test was performed initially using one animal. Due to the severe findings on cornea, iris and conjunctiva the test was stopped 24 hours after instillation. No further animal was employed.
0.1 mL of the test item was administered to the right eye of one animal.
The test item was placed into the conjunctival sac of the right eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material.
The left eye, which remained untreated, served as a control.


REMOVAL OF TEST SUBSTANCE
- Washing: test item was not rinsed

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE:
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1 and 24 hours after the administration.
The eye reactions were observed and registered.
One day before and 24 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Max. score:

2

Remarks on result:

other: not evaluable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Irritant / corrosive response data:

SCORE
- Cornea: 4
- Iris: not evaluable - no examination
- Conjunctivae (Redness): 2
- Conjunctivae (Chemosis): 4

Other effects:

no other effects

Any other information on results incl. tables

Examination of the treated eye

Time after administration	C O R N E A	I R I S	C O N J U N C T I V A E		F L U O R E S C E I N T E S T
	Opacity		Redness^#1	Chemosis^#2	Grade	Area
	A n i m a l n o. : 1
right eye: 0.1 mLTest item/animal
before dosing	0	0	0	0	0	0
60 minutes	3	^#3	3	3	-	-
24 hours	4	^#3	2	4	4	4

^#1    refers to palpebral and bulbar conjunctivae; excluding cornea and iris

^#2    swelling: refers to lids and/or nictitating membrane

^#3     not evaluable

-    no examination

Applicant's summary and conclusion

Conclusions:

The test substance causes irreversible damage to eyes in a study according to OECD 405 in rabbits.

Executive summary:

The purpose of this study was to obtain information on the influence of test item on rabbit eyes (irritation/corrosion test).

Under the present test conditions, a single instillation of 0.1 mL test item into the conjunctival sac of the right eye of one rabbit caused the following effects:

Corneal opacity was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.

The fluorescein test revealed corneal staining (whole surface) 24 hours after instillation.

Iridial response was not evaluable.

Conjunctival redness was observed at 60 minutes (grade 3) and 24 hours (grade 2) after instillation.

Chemosis was observed at 60 minutes (grade 3) and 24 hours (grade 4) after instillation.

As lesions such as a grade 4 corneal opacity are generally not reversible, the study was stopped 24 hours after instillation and the animal was humanely killed.