2-Propenoic acid, homopolymer

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acrylic acid

EC Number:

201-177-9

EC Name:

Acrylic acid

Cas Number:

79-10-7

Molecular formula:

C3H4O2

IUPAC Name:

acrylic acid

Constituent 2

Reference substance name:

2-carboxyethyl acrylate oligomers

Molecular formula:

Linear formula: C3H3O2(C3H4O2)nH Average n < 3. Average molecular weight = 208.8 g/mol

IUPAC Name:

2-carboxyethyl acrylate oligomers

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Specific details on test material used for the study:

- Source and lot/batch No.of test material: BA1I096877
- Storage condition of test material: at room temperature
- Physical description: clear colorless liquid
- Receipt date: 01 March 2002
- Expiration date: none provided

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's rabbitry, Thompson Station, TN
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.7 kg
- Housing: individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 43-63
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not specified

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100%

Duration of treatment / exposure:

3 minutes, 1 hour and 4 hours

Observation period:

14 days after patch application

Number of animals:

3 males per observation timepoint

Details on study design:

TEST SITE
- Area of exposure: 1 inch per 1 inch
- Type of wrap: gauze patch with elastic wrap over trunk and test area secured with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Residual test article removed using gauze moistened with deionized water followed by dry gauze

OBSERVATION TIME POINTS
- scoring 24, 48 and 72 hours and up to 14 days after patch removal

SCORING SYSTEM:
- Method of calculation: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: following 3-min exposure

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: following 3-min exposure

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: following 1-hr exposure

Score:

ca. 1.11

Max. score:

1.33

Reversibility:

fully reversible within: day 10

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: following 1-hr exposure

Score:

ca. 0

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: following 4-hr exposure

Score:

ca. 1.33

Max. score:

1.33

Reversibility:

fully reversible within: day 14

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: following 4-hr exposure

Score:

ca. 0.44

Max. score:

0.67

Reversibility:

fully reversible within: day 14

Results 7

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Sipomer B-CEA applied as such on the skin of New Zealand White rabbits for 3 minutes, 1 hour or 4 hours was not irritating.

Executive summary:

SIPOMER B-CEA was tested for primary dermal irritation/corrosion in 3 New Zealand White rabbits. Each of the 3 rabbits received three 0.5 ml doses of the test article (a liquid) on a dry compress in a single dermal dose to 2.5 cm²clipped area of the skin. The doses were held in contact with the skin under a semi-occlusive patch for an exposure period of 3 minutes, 1 hour, and 4-hours, respectively. Cutaneous examinations were performed at removal of the dressing, after wiping of the remaining test article, then daily for up to 14 days.

 

Exposure for 3 minutes produced very slight erythema (score 1) in 2/3 animals at removal of the dressing. The effects resolved completely by the 24-hour observation time. No oedema was observed.

Exposure for 1 hour produced very slight erythema (score 1) in all 3 animals at removal of the dressing. On one site, erythema increased to well-defined (grade 2) at 72 hours. The effects resolved completely by day 7 (2/3 animals) or day 10 (1 animal). No oedema was observed.

Exposure for 4 hours produced very slight erythema (score 1), and very slight (2/3 animals) to well-defined oedema (1 animal). Oedema resolved completely by the 72-hour observation time. On 3 test sites, the erythema increased to well-defined by the 72-hour scoring and persisted at day 7 on one site. Additional findings included superficial lightening and desquamation on 3 sites and 1 site, respectively. These effects resolved completely by day 14. The individual mean scores for each animal were 1.33 – 1.33 – 1.33 for erythema, and 0.33 – 0.67 – 0.33 for oedema. (or PII: 1.92)

 

Based on these results, SIPOMER B-CEA should not be classified as a skin irritant according to GHS criteria.