Registration Dossier

Administrative data

Description of key information

Sipomer B-CEA tested in vivo showed no skin irritation effects.

There is no specific eye irritation study. Due to the presence of up to 20% acrylic acid in the UVCB, using a direct analogy, Sipomer B-CEA is considered as causing serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
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
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
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
- Read-across hypothesis: "Different compounds have the same type of effect(s)"

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
- Target chemical: 2-Propenoic acid, homopolymer (purity ≥ 99.0%) = UVCB substance composed of acrylic acid monomers (Mw = 72 g/mol) and 2-carboxyethyl acrylate oligomers (average Mw = 208.8 g/mol)
- Source chemical: Acrylic acid = monoconstituent substance composed of acrylic acid monomers (Mw = 72 g/mol)

3. ANALOGUE APPROACH JUSTIFICATION
- Common structure: the constituents of the target and source chemicals share identical functional groups (i.e. one terminal carboxylic acid group and one terminal vinyl group) and only differ in the presence/absence of one or several -CH2-CH2-COO- pattern(s) in their structural backbones. This pattern being introduced as a result of (poly)addition reactions, it is only present in the polymerized units of acrylic acid (average number of -CH2-CH2-COO- patterns per vinyl group: < 3) and is absent from the monomer units.
- Common physico-chemical/fate properties: the target and source chemicals are both hydrophylic substances (log Pow < 1) with a high solubility in water and a low volatility (VP < 5 hPa). Both substances have a low potential for bioaccumulation in living organisms (log Pow < 4) and a low potential for persistence in environmental compartments (rapidly degradable).
- Common mode of action: the toxic effects of the target and source chemicals are expected to result from their acidic character (carboxylic acid group) and from the reactivity of their double bond (vinyl group). As the polyaddition reactions lead only to an increase in the chain length/molecular weight without an increase in the number of reactive functional groups, the low molecular-weight polymerized units of acrylic acid (from the test item) are not expected to exert higher toxicity than the monomer units. As a result, the target chemical, although only partially composed of acrylic acid monomers, is considered at the very worst to be as toxic as the source substance.

Further information (including data matrix) is available in the attached read-across justification document.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Remarks on result:
other: no quantitative values available
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In the absence of eye irritation data specific to the registered substance, read-across to the analogue acrylic acid is applied. Therefore the registered substance is considered to cause serious eye damage and is classified accordingly.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No specific respiratory irritation study is available. However, acrylic acid is known to be irritant to the respiratory tract [see for example: Silver EH, Leith DE, Murphy SD. Potentiation by triorthotolyl phosphate of acrylate ester-induced alterations in respiration. Toxicology, 22(3): 193-203, 1981]. Therefore, as a precaution, Sipomer B-CEA is considered to be able to cause respiratory irritation.

Justification for classification or non-classification

Sipomer B-CEA is not classified for skin irritation based on experimental data.

Sipomer B-CEA is classified as Eye Dam. 1, H318 by direct analogy to acrylic acid.

Sipomer B-CEA is classified as STOT SE 3, H335 in a precautionary approach.