2-Oxepanone, polymer with 1,4-butanediol

Endpoint summary

Description of key information

Studies of skin and eye irritation in the rabbit are available for the submission substance 2 -oxepanone, polymer with 1,4-butanediol.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16th September 1991 - 11th December 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 kg
- Housing: Housed individually in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce skin irritation were excluded.
- Diet: 80 g food, consisting of a standard laboratory diet LKK-20 per day during the acclimatisation period, with food available ad libitum during the testing period.
- Water: Available ad libitum.
- Acclimation period: 11 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20°C
- Humidity: 55 - 72%
- Air changes: Approximately 16 air changes per hour
- Photoperiod: 12 hours light/12 hours dark

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6cm2 patch on the back of each rabbit.
- Type of wrap if used: Occlusive wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was wiped after removal of the patch to remove any remaining test substance.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Graded according to responses observed.

Irritation parameter:

erythema 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

Irritation parameter:

erythema 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

Irritation parameter:

erythema 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

Irritation parameter:

edema 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

Irritation parameter:

edema 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

Irritation parameter:

edema 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:

A single dermal exposure to CAPA 203 for 4 hours did not cause erythema or oedema in the 3 rabbits on 30 minutes, 24, 48 and 72 hours after removal of the patch.

Individual scores for erythema and oedema

Animal	0.5 hours	24 hours	48 hours	72 hours	Total	Mean	Erythema
1	0	0	0	0	0	0
2	0	0	0	0	0	0
3	0	0	0	0	0	0

Animal	0.5 hours	24 hours	48 hours	72 hours	Total	Mean	Oedema
1	0	0	0	0	0	0
2	0	0	0	0	0	0
3	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

CAPA 203 was not found to be irritating to the skin of rabbits under the conditions of this study and does not require classification for skin irritation.

Executive summary:

To assess the primary skin irritation of CAPA 203 (2 -oxepanone, polymer with 1,4 -butanediol) in rabbits, a study was conducted in accordance with OECD Test Guideline 404 and GLP. A sample of 0.5 g CAPA 203 was applied to the shorn intact skin of three male rabbits and occluded under patches for four hours. Readings of the reactions for erythema and oedema were made at 30 minutes and at 24, 48 and 72 hours after patch removal. CAPA 203 did not cause any signs of skin irritation at any observation time. CAPA 203 was found to be non-irritating under the conditions of this study.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
A study of skin irritation / corrosion in the rabbit is available; in vitro testing is not required

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

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)

Specific details on test material used for the study:

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

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
A study of eye irritation in the rabbit is available. In vitro testing is not required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The skin irritation potential of 2-Oxepanone, polymer with 1,4-butanediol was investigated in rabbits in a GLP study conducted according to OECD Test Guideline 404 (Janssen, 1991). In the study, a sample of 0.5 g of the test material, CAPA 203, was applied to the shaven intact skin of three male rabbits and occluded under patches for four hours. Readings of the reactions for erythema and oedema were made at 30 minutes and at 24, 48 and 72 hours after patch removal. The test material did not cause skin irritation in the rabbits. Under the conditions of the study, 2-Oxepanone, polymer with 1,4-butanediol was not found to be irritating to skin.

Eye irritation

The eye irritation potential of 2-Oxepanone, polymer with 1,4-butanediol was investigated in rabbits in a GLP study conducted according to OECD Test Guideline 405 (Janssen, 1991). In the study, a sample of 0.1 ml of test material, CAPA 203 was placed into the conjuctival sac of one eye of each of three male rabbits. The eyes of the rabbits were examined and the 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. The test material did not cause eye irritation in rabbits. Under the conditions of the study, 2-Oxepanone, polymer with 1,4-butanediol was not found to be irritating to the eyes.

Justification for classification or non-classification

The submission substance (2 -oxepanone, polymer with 1,4 -butanediol) did not cause skin irritation in an acute dermal irritation/corrosion study. The substance does not meet the criteria for classification for skin corrosion or skin irritation according to the CLP Regulation.

The submission substance (2 -oxepanone, polymer with 1,4 -butanediol) did not cause irritation in an eye irritation study. The substance does not meet the criteria for classification for serious eye damage or serious eye irritation according to the CLP Regulation.