Fatty acids, C16-18, 2-butyloctyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-02-15 until 2005-02-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, 2-butyloctyl esters

EC Number:

309-831-6

EC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Cas Number:

101227-08-1

Molecular formula:

C28H56O2 - C30H60O2

IUPAC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ISOFOL ESTER 1202, Fettsauren, C16-18, 2-Butyloctylester
- Substance type: Ester
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Little Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 7 to 10 months
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: The study took place in animal rooms No. 5 and 8 provided with filtered air at a temperature of 20°C ± 3°C, relative humidity of 55 % ± 15 % and air changes 10 times/ hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
- Acclimation period: at least 1 week, throughout the study the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10 times/ hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the test animal

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation with 20 ml 0.9 % sodium chloride solution
- Time after start of exposure: 24 h

SCORING SYSTEM:
Cornea:
Opacity: degree of density (readings should be taken frommost dense area):
Score 0: no ulceration or opacity
Score 1: scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
Score 2:easily discernible translucent area; details of iris slightly obscured
Score 3: nacrous area; no details of iris visible; size of pupil barely discernible
Score 4: opaque cornea, iris is not dicernible through the opacity

Area of the cornea involved:
Score 1: One quarter (or less) but not zero.
Score 2:More than one quarter. but less than half.
Score 3: More than half, but less than three quarters.
Score 4: More than three quarters, up to whole area.

Iris:
Score 0: normal
Score 1: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (sluggish reaction is considered to be an effect)
Score 2: hemorrhage, gross destruction, or no reaction to light

Conjunctiva: Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Score 0:normal
Score 1: some blood vessels hyperaemic (injected)
Score 2:diffuse, crimson colour; individual vessels not easily discernible
Score 3: diffuse beefy red

Chemosis: swelling (refers to lids and/or nictating membranes)
Score 0: normal
Score 1: sorne swelling above normal
Score 2: obvious swelling, with partial eversion of lids
Score 3: swelling, with lids about half closed
Score 4: swelling, with lids more than half closed

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Eye irritating effects following a single instillation of 0.1 mL of Isofol Ester 1202 to rabbit eyes (grading according to OECD TG 405)

 

Animal	Effect	Score (time after application)
		1 h	24 h	48 h	72h	Mean	F
1	Cornea	1 (degree) 2 (area)	0 0	0 0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-
2	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctiva Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-
3	Cornea	0	0	0	0	0	-
	Iris	0	0	0	0	0	-
	Conjunctivae Redness	1	1	0	0	0.33	-
	Chemosis	0	0	0	0	0	-

 

 

In general, the irritating effect of Isofol Ester 1202 on the rabbit eye was weak.

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of the study described in the report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance shall not be classified as eye irritating.

Executive summary:

In a OECD 405 study, 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of 3 Little Russian rabbits for 24 hours. Eyes were washed with 20 ml 0.9 % sodium chloride solution at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion).

One hour after the application of the test item animal No. 2928 showed scattered or diffuse opacity quarter the area of the cornea of the cornea on more than one quarter. Additionally some hyperaemic, conjunctival blood vessels were observed. Animals No. 3164 and No. 3163 showed some hyperaemic, conjunctival blood vessels only. 24 h. after the application of the test item animals No. 2928, No. 3164 and No. 3165 showed some hyperaemic, conjunctival blood vessels. 48 and 72 h. after the application of the test item animals No. 2928, No. 3164 and No. 3163 were free of any signs of eye irritation.

 

In this study, the test substance is not irritating to the eye according to EU regulations.

 

This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 405) for an acute eye irritation/corrosion study.