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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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
Chemical structure
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
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: following 3-min exposure
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: following 3-min exposure
Score:
ca. 0
Max. score:
0
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
Irritation parameter:
edema score
Basis:
mean
Time point:
other: following 1-hr exposure
Score:
ca. 0
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
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
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
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
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
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
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
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.