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EC number: 221-066-9 | CAS number: 2996-92-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24-03-1980 to 27-03-1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The restrictions was feeding conditions and analytical purity of the test substance was not provided in the study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- feeding condition and analytical purity was not stated in the study report.
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Act as stated in the Code of Federal Regulations, 16 CFR 1500.42.
- Deviations:
- yes
- Remarks:
- feeding condition and analytical purity was not stated in the study report.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trimethoxyphenylsilane
- EC Number:
- 221-066-9
- EC Name:
- Trimethoxyphenylsilane
- Cas Number:
- 2996-92-1
- Molecular formula:
- C9H14O3Si
- IUPAC Name:
- trimethoxy(phenyl)silane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: Not stated.
- Weight at study initiation: Not stated.
- Housing: Individually in elevated metal cages.
- Diet : Commerical rabbit ration (Purina Lab Rabbit Chow©).
- Water : Water (via automated watering system) were available ad libitum.
- Acclimation period: Approximately for one-week period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated.
- Humidity (%): Not stated.
- Air changes (per hr):Not stated.
- Photoperiod (hrs dark / hrs light):Not stated.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Abraded and shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- Reading time points: 24 and 48 h. No further observation required.
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Trunk. The skin at one site was abraded with minor incision and the skin of the other site remained intact.
- % coverage: Not stated
- Type of wrap if used: One-half-inch square gauze patch (two layers thick) which was secured with a non-absorbent binder composed of polyethylene tubing and Coban elastic bandage (Minnesota Minning and Manufacturing Company, St. Paul, Minnoesota).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were wiped with gauze.
.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable.
- Irritant / corrosive response data:
- No erythema, oedema, ot other dermal effects were noted at any exposure site. The primary irritation score was zero.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a reliable skin irritation study conducted according to OECD TG 404 but not in compliance with GLP, showed the test material was not a skin irritant.
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