Registration Dossier
Registration Dossier
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EC number: 618-347-7 | CAS number: 9003-01-4
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:
- 2 002
- 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
- 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
- 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
- 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
Constituent 1
Constituent 2
impurity 1
- 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.
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