2-Oxepanone, polymer with 1,6-hexanediol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

The study on a similar substance serves as data source for the endpoint study record "CAPA 203 skin irritation: Janssen, 1991 [TARGET]" and the justification for read-across is provided there.

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

Justification for type of information:

Study serves as data source; read-across justification is found in Target record.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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

Justification for type of information:

See attached justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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:

The read-across substance 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. A similar lack of skin irritation potential is predicted for CAPA 2047A

Executive summary:

To assess the primary skin irritation of the read-across substance 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. A similar lack of skin irritation potential is therefore predicted for CAPA 2047A

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.