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EC number: 266-380-7 | CAS number: 66492-51-1
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- EC Number:
- 266-380-7
- EC Name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- Cas Number:
- 66492-51-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (5-ethyl-1,3-dioxan-5-yl)methyl acrylate
- Details on test material:
- - Name of test material (as cited in study report): SR-531 CTFA
- Physical state: clear light yellow liquid
- Analytical purity: not indicated
- Lot/batch No.: LFP20FB
- Expiration date of the lot/batch: 2000-07-16
- Stability under test conditions: stable
- Storage condition of test material: in the refrigerator in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 1.289 - 1.487 kg
- Housing: individually
- Diet (e.g. ad libitum): standard lab rabbit diet (Charles River Breeding and Maintenance diet for rabbits) app. 100g / day and animal,
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 14 days
1, 24, 48, 72h, 7, 14 days after exposure - Number of animals:
- 3m
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3cm
- Type of wrap if used: micropore tape, secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing with water
- Time after start of exposure: 4h
Dry or sticky remnants were present on the skin up to 72h
SCORING SYSTEM: Draize
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) 4
In cases where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) is given.
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 approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72h (mean)
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- No mortality occured. Lethargy, pale skin, diarrhoea, loss of appetite, piloerection, emaciation and/or swelling of the abdomen were noted in animal 570 and 572 and the animals felt cold from 72 hours or 7 days after treatment onwards until 7 or 13 days respectively after treatment. These signs were evaluated by the veterinarian and study director and were considered signs of a general decline in health and not test substance related signs. This event was evaluated by the study director and considered not to have affected the study integrity.
Any other information on results incl. tables
| Time after exposure | Animal #1 | Animal #2 | Animal #3 | |||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1h | 2 | 3 | 2 | 3 | 2 | 3 |
| 24h | 3 | 2 | 3 | 2 | 3 | 2 |
| 48h | 3 | 3 | 4 | 3 | 3 | 4 |
| 72h | 3 | 2 | 4 | 2 | 3 | 3 |
| 7 days | 1 | 0 | 2 | 2 | 2 | 1 |
| 14 days | 0 | 0 | 0 | 0 | 0 | 0 |
Bald skin was observed on day 14 (animal #2, 3)
Scaliness was observed after 7 days in all animals and on day 14 in animal no. 1
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Conclusions:
- Dermal application of the test substance resulted in a primary irritation index of 5.78 (severely irritating) when applied to the intact rabbit skin.
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