Registration Dossier
Registration Dossier
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EC number: 480-370-1 | CAS number: 21743-27-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-05-09 until 2005-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD test under GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 480-370-1
- EC Name:
- -
- Cas Number:
- 21743-27-1
- Molecular formula:
- Hill formula: C11H25NO4Si CAS formula: C11H25NO4Si
- IUPAC Name:
- 4-[(triethoxysilyl)methyl]morpholine
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 Deutschland, D-88353 Kisslegg
- Weight at study initiation: 2.2 kg all animals
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated but shaved other side served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: gauze patch held with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: as stated in Guideline OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Other effects:
- No treatment related effects observed.
Any other information on results incl. tables
Comments:
0.5 ml undiluted test item (density = 1.00155 mg/ml) were applied which corresponds to 501 mg.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the skin of rabbits.
- Executive summary:
An acute dermal Irritation/Corrosion test according to OECD 404 was performed. The test item was semi-occlusively applied to the skin on 3 female New Zealand White Rabbits Crl:KBL (NZW) and held in contact throughout a 4 hour period. The test item showed no skin effects throughout the observation period. There were no significant body weight changes during contact and observation period. No treatment related effects were observed. Therefore, the substance should be not classified.
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