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Registration Dossier
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EC number: 212-133-3 | CAS number: 764-99-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-12-19 to 2007-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-[oxybis(ethyleneoxy)]diethylene
- EC Number:
- 212-133-3
- EC Name:
- 1,1'-[oxybis(ethyleneoxy)]diethylene
- Cas Number:
- 764-99-8
- Molecular formula:
- C8H14O3
- IUPAC Name:
- {2-[2-(ethenyloxy)ethoxy]ethoxy}ethene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.8 - 3.1 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water: Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 30-49%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL/site.
- Concentration: Undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days (The skin reactions were evaluated after 1, 24, 48, and 72 hours)
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: The trunk of the rabbit was wrapped with a piece of fabric (a semiocclusive dressing) and secured with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. The test sites were wiped with paper towels saturated with tap water and blotted dry with paper towels.
- Time after start of exposure: 4 h
SCORING SYSTEM:
according to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no erythema or edema noted at any observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
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