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EC number: 266-380-7 | CAS number: 66492-51-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb. 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan no. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- 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): Laromer LR 8887
- Physical state: clear, yellowish liquid
- Analytical purity: 78.1 g/100 g by H-NMR spectroscopy
- Purity test date: 2011-11-03
- Lot/batch No.: 110009P040
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranteed by sponsor
- Storage condition of test material: room temperature in the dark
- Other: density as determined by Bioassay: 1.098 g/ml
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: males 228 - 237g, females: 209-211g
- Fasting period before study: no
- Housing: single in makrolon cages, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: app. 40cm²
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82ml/kg b.w. - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of exposure, at least once daily on each workday thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin findings (30-60min after exposure, several times thereafter)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured
- Clinical signs:
- other: no systemic clinical signs were observed. For local irritation, see table 1 (males) and table 2 (females)
- Gross pathology:
- no abnormalities noted
Any other information on results incl. tables
Table 1:
| Nature and duration of local clinical signs(males) | |||||
| Dose (mg/kg bw): | 2000 | ||||
| Sex: | male | ||||
| Administration: | 1 | ||||
| No. of animals: | 5 | ||||
| Animal No.: | R 954 | R 955 | R 956 | R 957 | R 958 |
| Abnormalities: | |||||
| Erythema grade 1: | d9 - d12 | d7 - d9 | d13 | d6 - d9 | d8 - d9 |
| Erythema grade 2: | d1 - d2; d7 - d8 |
d1 - d2; d6 | d1 - d2; d9 - d12 |
d1 - d5 | d1 - d2; d7 |
| Erythema grade 3: | d5 - d6 | d5 | d5 - d8 | - | d5 - d6 |
| Edema grade 1: | - | d1 - d2 | d1 - d2 | d1 - d2 | d1 - d2 |
| Incrustations: | d5 - d8 | d5 - d6 | d5 - d12 | - | d5 - d8 |
| Scaling: | d5 - d 13 | d5 - d7; d9 | d5 - d14 | d5 - d8 | d5 - d9 |
| Sever scaling: | - | d8 | - | - | - |
| Skin findings beyond the application area: |
- | - | d6 - d13 | - | - |
| Significant scratching behavior |
d2 - d6 | d2 - d5 | d2 - d6 | d2 - d5 | d2 - d6 |
d: day
Table 2:
| Nature and duration of local clinical signs(females) | |||||
| Dose (mg/kg bw): | 2000 | ||||
| Sex: | female | ||||
| Administration: | 1 | ||||
| No. of animals: | 5 | ||||
| Animal No.: | R 959 | R 960 | R 961 | R 962 | R 963 |
| Abnormalities: | |||||
| Erythema grade 1: | d12 - d13 | d14 | d12 - d13 | d12 - d13 | d14 |
| Erythema grade 2: | d1 - d2; d8 - d9 |
d1 - d2; d12 - d13 |
d1 - d2; d7 - d9 |
d1 - d2 | d1 - d2; d12 - d13 |
| Erythema grade 3: | d5 - d7 | d5 - d9 | d5 - d6 | d5 - d9 | d5 - d9 |
| Edema grade 1: | d6 - d9 | - | - | d6 | - |
| Edema grade 2: | - | - | - | d5 | - |
| Incrustations: | d5 - d12 | d5 - d14 | d5 - d12 | d5 - d14 | d5 - d14 |
| Scaling: | d5 - d14 | d5 - d14 | d5 - d9 | d5 - d14 | d5 - d14 |
| Skin findings beyond the application area: |
- | d6 - d14 | d6 - d9 | d6 - d14 | d6 - d14 |
| Significant scratching behavior |
d1 - d5 | d1 - d5 | d2 | d2 - d3 | d1 - d5 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test material after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. The following test item-related local effects were recorded during the course of the study:
· No mortality occurred
· No signs of systemic toxicity were observed in the animals
· Slight to moderate erythema (grade 1 to 3)
· Slight to well-defined edema (grade 1 to 2)
· Incrustations
· Scaling
· Severe scaling
· Skin findings beyond the application area
· Significant scratching behavior
· The mean body weight of the animals increased within the normal range throughout the study period
· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
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