ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25/11/1991 - 28/11/1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol

EC Number:

500-092-7

EC Name:

ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol

Cas Number:

36890-68-3

Molecular formula:

C6H10O2x.C4H8O3

IUPAC Name:

2-oxepanone, polymer with 2,2'-oxybis[ethanol]

additive 1

Reference substance name:

Glycerol

EC Number:

200-289-5

EC Name:

Glycerol

Cas Number:

56-81-5

Molecular formula:

C3H8O3

IUPAC Name:

glycerol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Test animals were obtained from Harlan Olac, Zeist, The Netherlands.
- Weight at study initiation: 1.8 – 2.2 kg
- Housing: Rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded
- Diet and Water - Test animals received 80g food (a standard laboratory diet LKK-20, Hope farms, Woerden, The Netherlands) per day during the acclimatization period of 11 days. During the experiment they had free access to food and water
- Acclimation period: A period of 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19- 20°C
- Humidity: 52-72%
- Air changes :16 air changes per hr
- Photoperiod: Artificial light from 7a.m till 7 p.m.
- Radio sound on 7 a.m. till 7 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:

Not applicable, the eyes were not rinsed after the instillation of the test item.

Observation period (in vivo):

1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

3 males

Details on study design:

- 0.1 mL of test substance was instilled in the left eye of test animals
- Washing : The eyes were not rinsed after application of the test material.

SCORING SYSTEM: Draize scale, according to OECD TG 405

TOOL USED TO ASSESS SCORE: Hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, #2, #3

Time point:

other: 1hr after treatment

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24hrs

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(discharge)

Basis:

animal: #1, #2, #3

Time point:

other: 1 hr after treatment

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24hrs

Remarks:

Lacrimation and with addition a viscous clear liquid in rabbits number 2 and 3

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test substance did not cause corneal or iridial effects during the study. Minimal conjunctiva redness was noticed 1 hr after application of the test material in all animals but this effect disappeared after 24hrs. Similarly, conjunctiva discharge (lacrimation with in addition a viscous clear liquid in rabbits no’s 2 and 3) was noticed 1 hr after application of the test material in all animals but this effect disappeared after 24hrs

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Scores of the irritation reactions after application of 0.1ml CAPA 304 to the eye of three rabbits

 

Animal No.	Region of the eye		Pretest	Hours (h) after treatment				Mean^a
				1h	24h	48h	72h
1	Cornea	Opacity	0	0	0	0	0	0
		Area involved	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjuctiva	Redness	0	1	0	0	0	0 0
		Chemosis	0	0	0	0	0
		Discharge	0	1^b	0	0	0
2	Cornea	Opacity	0	0	0	0	0	0
		Area involved	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjuctiva	Redness	0	1	0	0	0	0 0
		Chemosis	0	0	0	0	0
		Discharge	0	1^b	0	0	0
3	Cornea	Opacity	0	0	0	0	0	0
		Area involved	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjuctiva	Redness	0	1	0	0	0	0 0
		Chemosis	0	0	0	0	0
		Discharge	0	1^b	0	0	0

a Mean of 24, 48 and 72 hour readings

b Lacrimation with in addition a viscous clear liquid in rabbits number 2 and 3

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, CAPA 304 induced no significant eye irritation to test animals. The test substance is not classified as irritating to the eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP)

Executive summary:

In this eye irritation study performed according to the OECD guideline No. 405 and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the left eye of 3 New Zealand White Male Rabbits. The eyes were not rinsed after the instillation of the test item. The right eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.

No corneal or iridial effects were noted during the study. Very slight irritation of the conjunctiva and lacrimation was observed in 3 rabbits 1 hour after instillation of 0.1 ml CAPA 304 in their left eye. This effect however disappeared after 24hrs. The calculated mean score for redness, discharge, chemosis, iris and corneal lesions for all animals at 24, 48 and 72h after treatments was 0. One hour after instillation of the test material; discharge of any amount different from normal (does not include small amount observed in inner canthus of normal animals) was noticed in all animals. Lacrimation and with addition a viscous clear liquid in rabbits number 2 and 3. The effects observed 1hr after instillation was test material disappeared after24 hours.

 Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP)