2-Oxepanone, polymer with 1,4-butanediol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15th November 1991 to 10th January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not relevant.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Oxepanone, polymer with 1,4-butanediol

Cas Number:

31831-53-5

IUPAC Name:

2-Oxepanone, polymer with 1,4-butanediol

Constituent 2

Reference substance name:

CAPA 2043

IUPAC Name:

CAPA 2043

Constituent 3

Reference substance name:

Reference substance 001

EC Number:

932-682-9

Cas Number:

31831-53-5

Constituent 4

Reference substance name:

2-Oxepanone, polymer with 1,4-butanediol

EC Number:

608-670-1

Cas Number:

31831-53-5

Molecular formula:

l(HO(CH2)5CO)-O(CH2)4O-(CO(CH2)5OH)m

IUPAC Name:

2-Oxepanone, polymer with 1,4-butanediol

Test material form:

other: liquid.

Details on test material:

- Name of test material (as cited in study report): Capa 2043
- Physical state: Colourless liquid.
- Analytical purity: 97%
- Lot/batch No.: WAC000392
- Expiration date of the lot/batch: 17th February 2014
- Storage condition of test material: Stored in the dark at room temperature.

Specific details on test material used for the study:

CAPA 203 (2-oxepanone, polymer with 1,4-butanediol)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac, Zeist, The Netherlands.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: The rabbits were housed individually in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded.
- Diet: 80 g food consisting of a standard laboratory LKK-20 ad libitum.
- Water: Water available ad libitum
- Acclimation period: 11 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22°C
- Humidity 52 - 70%
- Air changes: Approximately 16 air changes per hour.
- Photoperiod: 12 hours light/12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each rabbit acted as control.

Amount / concentration applied:

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

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

After the acclimatisation period, both eyes of each rabbit were examined with the aid of a slit-lamp. Only those rabbits without eye defects or signs of irritation were used. A quantity of 0.1 mL CAPA 203 was placed in the conjunctival sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for a short period and the rabbit was released. The other eye remained untreated and served as a control. Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment. Scoring of the irritation was performed according to the grades given in the Draize method.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation were observed in any of the three rabbits after instillation of 0.1 mL CAPA 203.

Any other information on results incl. tables

Individual irritation scores

Animal #	Finding		Pretest	Hours (h) after treatment						Mean (24 -72h)
				1h	24h		48h		72h
1	Cornea	Opacity Area involved	0 0	0 0		0 0		0 0	0 0	0
	Iris		0	0		0		0	0	0
	Conjunctiva	Redness Chemosis Discharge	0 0 0	0 0 0		0 0 0		0 0 0	0 0 0	0 0
2	Cornea	Opacity Area involved	0 0	0 0		0 0		0 0	0 0	0
	Iris		0	0		0		0	0	0
	Conjunctiva	Redness Chemosis Discharge	0 0 0	0 0 0		0 0 0		0 0 0	0 0 0	0 0
3	Cornea	Opacity Area involved	0 0	0 0		0 0		0 0	0 0	0
	Iris		0	0		0		0	0	0
	Conjunctiva	Redness Chemosis Discharge	0 0 0	0 0 0		0 0 0		0 0 0	0 0 0	0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no signs of irritation in any rabbit at any timepoint in this study. CAPA 203 was not shown to be an eye irritant and does not therefore require classification for eye irritation according to the CLP Regulation.

Executive summary:

A study to assess the primary eye irritation of CAPA 203 (2 -oxepanone, polymer with 1,4 -hexanediol) in rabbits was conducted in accordance with OECD Guideline 405 and GLP. 0.1 mL CAPA 203 was instilled into the conjunctival sac of one eye of each of three male rabbits. The eyes of the rabbits were examined and ocular reactions were graded at intervals up to and including 72 hours after treatment. Following the observation period, there were no signs of irritation observed in the three rabbits.