Registration Dossier
Registration Dossier
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EC number: 203-275-7 | CAS number: 105-16-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-11-06 - 1991-11-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(diethylamino)ethyl methacrylate
- EC Number:
- 203-275-7
- EC Name:
- 2-(diethylamino)ethyl methacrylate
- Cas Number:
- 105-16-8
- Molecular formula:
- C10H19NO2
- IUPAC Name:
- 2-(diethylamino)ethyl methacrylate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.27 - 2.55 kg
- Housing: individually in suspended metal cages
- Diet: standard laboratory diet, ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 49 - 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Non treated skin served as a control.
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours after removal of patch.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 5 cm2
- Type of wrap if used: elasticated corset (TURBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4hours later
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation(inujuries in depth) 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: well defined erythema
- Irritant / corrosive response data:
- Adverse reactions prevented accurate evaluation of erythema and oedema at all treated skin sites at the 24, 48 and 72-hour observations. The treatment sites were assigned a grade 4 for erythema on the Draize scale due to injuries in depth.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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