Glycerides, C8-18 and C18-unsatd., reaction products with ethylene oxide and glycerol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23rd December 1998 to 24th March 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of tryglycerides, C8-C18 (even numbered) and C18-unsaturated, glycerine and ethylene oxide

EC Number:

939-459-5

Cas Number:

1471311-24-6

Molecular formula:

Not applicable (a generic molecular formula can not be provided for this specific UVCB substance)

IUPAC Name:

Reaction products of tryglycerides, C8-C18 (even numbered) and C18-unsaturated, glycerine and ethylene oxide

Details on test material:

- Physical state: pale yellow liquid
- Storage condition of test material: The test substance was stored at room temperature in the dark.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: B&K Universal G.J., S.L.
- Age at study initiation: 10-11 week old
- Weight at study initiation: 2.6-3.0 kg
- Housing: The rabbits were housed individually in stainless steel cages with a grille floor (48 x 595 x 37 cm), placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet UAR 112, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 21st December 1998 To: 25th January 1999

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Observation period (in vivo):

1, 24, 48 and 72 hours, 7 and 14 day after treatment

Number of animals or in vitro replicates:

Three animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was done

SCORING SYSTEM:
Cornea: Opacity:
- No ulceration or opacity 0
- Scattered or diffuse areas of opacity, details of iris clearly visible 1
- Easily discernible translucent area, details of iris slightly obscured 2
- Nacrous area, no details of iris visible, size of pupil barely discernible 3
- Opaque cornea, iris not discernible through the opacity 4

Iris:
- Normal 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reating to light 1
- No reaction to light, haemorrhage, gross destruction 2

Conjunctivae: Redness:
- Blood vessels normal 0
- Some blood vessels definitely hyperaemic 1
- Diffuse, crimson colour, individual vessels not easily discernible 2
- Diffuse beefy red 3

Conjunctivae: Edema:
- No swelling 0
- Slight swelling 1
- Obvious swelling with partial eversion of lids 2
- Swelling with lids about half-closed 3
- Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: Observation of the cornea was completed in each of the readings performed, with the exception of the one done one hour after administration, by applying a 2% aqueous sodium fluorescein solution.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

In the course of the first hour after instillation, the test substance induced in all the animals, hyperaemia in the palpebral conjunctivae and all the animals presented diffuse, crimson-coloured redness (grade 2) and lacrimation ranging from lacrimation with wetness of the eyelids and adjacent fur to lacrimation affecting a considerable area around the eye. Similarly, two animals presented swelling with lids about half-closed (grade 3) and the remaining animal presented slight swelling (grade 2).
In the reading made 24 hours after application, some blood vessels definitely hyperaemic (grade 1) were recorded in the conjunctivae of all of the animals.
Two of these animals also presented obvious swelling with partial eversion of lids (grade 2).
Some blood vessels were still definitely hyperaemic (grade 1) in one of the animals after 48 hours. In addition, this animal presented slight edema (grade 1) in this reading.
In the subsequent readings, the ocular lesions were noted to have partially remitted.

Other effects:

The behaviour and physical condition of the rabbits were normal throughout the study.

Any other information on results incl. tables

Table 1: Primary eye irritation test

 

Animal	Region of eye	1 h	24 h	48 h	72 h	7 d	14 d
1	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Hyperaemia	2	1	0	0	0	-
	Conjunctivae Edema	3	2	0	0	0	-
2	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctivae Hyperaemia	2	1	0	1	1	0
	Conjunctivae Edema	2	0	0	0	0	0
3	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Hyperaemia	2	1	1	1	0	-
	Conjunctivae Edema	3	2	1	0	0	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is considered to be non-irritant to the eye.

Executive summary:

The test substance was administered for the study of primary eye irritation. The study was conducted according to EU method B.5 and OECD guideline 405.

In the course of the first hour after instillation, the test substance induced in all the animals, hyperaemia in the palpebral conjunctivae and all the animals presented diffuse, crimson-coloured redness (grade 2) and lacrimation ranging from lacrimation with wetness of the eyelids and adjacent fur to lacrimation affecting a considerable area around the eye. Similarly, two animals presented swelling with lids about half-closed (grade 3) and the remaining animal presented slight swelling (grade 2).

In the reading made 24 hours after application, some blood vessels definitely hyperaemic (grade 1) were recorded in the conjunctivae of all of the animals.

Two of these animals also presented obvious swelling with partial eversion of lids (grade 2).

Some blood vessels were still definitely hyperaemic (grade 1) in one of the animals after 48 hours. In addition, this animal presented slight edema (grade 1) in this reading.

In the subsequent readings, the ocular lesions were noted to have partially remitted.

The mean values at 24, 48 and 72 hours post-administration, for each type of lesion for the three animals were:

- Corneal opacity 0

- Iridal lesions 0

- Hyperaemia 0.67

- Edema 0.56

The substance is considered to be non-irritant to the eye.