Registration Dossier
Registration Dossier
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EC number: 213-934-0 | CAS number: 1067-53-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 March 1999 - 20 May 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-methoxyethoxy)vinylsilane
- EC Number:
- 213-934-0
- EC Name:
- Tris(2-methoxyethoxy)vinylsilane
- Cas Number:
- 1067-53-4
- Molecular formula:
- C11H24O6Si
- IUPAC Name:
- ethenyl-tris(2-methoxyethoxy)silane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver PA
- Age at study initiation: young adult
- Weight at study initiation: 3507 - 3642 g
- Housing:Individual, suspended in wire mesh cages.
- Diet: PMI Nutrition International, Inc. Certified Lab Diet 5322, circa 150 g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 19.4 °C
- Humidity (%): 45.6-46.8 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: Cotton gauze patches, secured with a gauze binder and surgical tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Excess test material was removed from treated skin areas following exposure.
- Time after start of exposure:4 hours
SCORING SYSTEM: Draize
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
- Reversibility:
- other: No effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See results section.
- Other effects:
- See results section.
Any other information on results incl. tables
No deaths or body weight changes were observed. Very slight
erythema was noted for one animal at the 48- and 72-hour
observations. There was no edema or other dermal
irritation noted. A primary irritation index score of 0.2 was
calculated from the results, consistent with a slight skin
irritation potential in the rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation toxicity study, conducted according to OECD test guideline 404 and in compliance with GLP, the test substance was found to be slightly irritating, as determined in a reliable study. The observed effects do not meet the criteria for classification as a skin irritant in the EU.
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