Registration Dossier
Registration Dossier
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EC number: 238-518-6 | CAS number: 14513-34-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2000/09/28 - 2000/10/01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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:
- 3-trimethoxysilylpropyl methacrylate
- EC Number:
- 219-785-8
- EC Name:
- 3-trimethoxysilylpropyl methacrylate
- Cas Number:
- 2530-85-0
- Molecular formula:
- C10H20O5Si
- IUPAC Name:
- 3-(Trimethoxysilyl)propyl 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): A-174 NT
- Substance type: Alkoxy-Si
- Physical state: Clear colourless liquid
- Storage condition of test material: In the original container at room temperature. Once opened, the material was be blanketed under nitrogen prior to being resealed.
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: 2750 to 2981g at initiation of dosing
- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research laboratories, Inc., in accordance with standard operating procedures.
- Diet: PMI Nutrition International, Inc. Certified Rabbit LabDiet 5322 was offered at approximately 150g per day during the study.
- Water: Municipal water was provided ad libitum
- Acclimation period: minimum of 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-68 (19.4-20 °C)
- Humidity (%): 50-59
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: none
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 2M, 1F
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: A two - ply gauze patch secured in place with tape. The patches were overwrapped with gauze binder and secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was wiped with a disposable paper towel moistened with deionized water.
- 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
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- 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
- 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
- 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
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A primary irritation index of 0.1 was calculated from the results, consistent with a descriptive rating classification of slightly irritating.
- Other effects:
- No deaths or remarkable body weight changes were observed. Very slight erythema was noted on one animal at the 30-60 minute observation. There was no edema, nor were there any other dermal findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Primary Irritation Index value of 0.1 was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP. The skin reactions observed do not meet the criteria for classification as a skin irritant in the EU.
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