Registration Dossier
Registration Dossier
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EC number: 213-427-4 | CAS number: 947-42-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 to 28 August 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance with an appropriate guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphenylsilanediol
- EC Number:
- 213-427-4
- EC Name:
- Diphenylsilanediol
- Cas Number:
- 947-42-2
- Molecular formula:
- C12H12O2Si
- IUPAC Name:
- diphenylsilanediol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): diphenylsilanediol
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, Lyon, France
- Age at study initiation: not stated
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: polystyrene cages with perforated floor
- Diet (ad libitum): rabbit complete pelleted maintenance food (U.A.R., Villemoisson Sur Ogre, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: minimum 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 25 to 28 August 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g in a paste with 0.69 ml of distilled water
VEHICLE
- Amount(s) applied: 0.69 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 male
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: Codex hydrophilic eight layer gauze pad (approximately 2.4 x 2.4 cm) crimped gauze bandage (Creplux, Laboratoires Molypharm, Veache, France) held in place by adhesive and perforated tape (Peloplast, Laboratoires Fournier, Dijon, France).
REMOVAL OF TEST SUBSTANCE
- Washing: distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Examined at 1, 24, 48 and 72 hours after removal.
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1.0 mm) 3
Severe oedema (raised more than 1.0 mm beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating
- Executive summary:
In a study conducted according to OECD 405 and in compliance with GLP, diphenylsilanediol was found to be slightly irritating to rabbit eyes, the effects on the iris showing evidence of reversibility after 72 hours in some animals (further observations were not conducted). The substance does not meet the criteria for classification as Eye Irritant Category 2 according to Regulation (EC) No 1272/2008.
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