Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Mar - 02 Apr 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

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:

Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters

EC Number:

292-947-3

EC Name:

Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters

Cas Number:

91031-45-7

Molecular formula:

C38-42H74-82O6

IUPAC Name:

Fatty acids, C16-18 (even-numbered), 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical denomination: Fatty acid, C16-18, 1,2-Ethandiyl Bis (Oxy-2,1-Ethandiyl) ester
- Substance type: pure substance
- Physical state: white solid
- Analytical purity: 100%
- Lot/batch No.: 051031017
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 27-28 months
- Weight at study initiation: mean 2650 g
- Housing: single holding in cage
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 days
Reading time points: 1, 24, 48 and 72 h and 8 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was thoroughly rinsed with warm water.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Cornea: no effects were observed after 1 h in any animal. After 24 h slight corneal opacity was noted in 2 of 3 animals. In 1 animal the corneal opacity was fully reversible after 48 h of application, in the other animal the effects were persistent up to 72 h and were fully reversible on Day 8. The third animal showed no effects during the study period.
See Table 1 for further details.
Iris: no effects were observed after 1 h in any animal. After 24, 48 and 72 h 2 of 3 animals showed mild iritis which was fully reversible at 8 days post-application. The third animal showed no effects during the study period.
Conjunctivae: after 1 h mild redness was observed in all animals. After 24 h 2 of 3 animals showed strong effects persisting up to 72 h and being fully reversible at 8 days post-application. The third animal showed mild effects after 24 h only.
Chemosis: no effects were observed after 1 h in any animal. After 24 h one animal showed mild effects which were decreased after 48 and 72 h to mild effects. One animal showed mild effects after 24 and 48 h which were fully reversible after 72 h of application. The third animal showed mild effects only after 24 h.
Exsudation: 1 h after application all animals showed mild effects. After 24 and 48 h only one animal presented strong effects which were reduced to mild effects 72 h after application, being fully reversible after 8 days. Two animals showed no effects from 24 h on up to the end of the observation period.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

 

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1	1	0	0	0
	24	3	2	1	1
	48	3	1	1	1
	72	3	1	1	1
	average	3.0	1.3	1.0	1.0	Time to reversion	8 days	8 days	8 days	8 days
2	1	1	0	0	0
	24	3	1	1	1
	48	3	1	1	0
	72	3	0	1	0
	average	3.0	0.7	1.0	0.3	Time to reversion	8 days	72 h	72 h	72 h
3	1	1	0	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.0	0.0	0.0	Time to reversion	48 h	not applicable	not applicable	not applicable
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	1.00	0.00	0.00	0.00
	24	2.33	1.00	0.67	0.67
	48	2.00	0.67	0.67	0.33
	72	2.00	0.33	0.67	0.33
	24+48+72	2.11	0.67	0.67	0.44

 

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Eye irrit 2, H319
DSD: Xi, R36