Registration Dossier
Registration Dossier
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EC number: 229-929-1 | CAS number: 6843-66-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jan to 06 Feb 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
Test material
- Reference substance name:
- Dimethoxydiphenylsilane
- EC Number:
- 229-929-1
- EC Name:
- Dimethoxydiphenylsilane
- Cas Number:
- 6843-66-9
- Molecular formula:
- C14H16O2Si
- IUPAC Name:
- dimethoxydiphenylsilane
- Details on test material:
- - Name of test material (as cited in study report): DYNASYLAN D 6010
- Substance type: Alkoxy silane
- Physical state: Liquid
- Stability under test conditions: Less than one year
- Storage condition of test material: Closed container, protected from moisture
- Lot/batch No.: 0637/81 547
- Expiration date of the lot/batch: Not given, but stability is less than one year.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleiner Weißer Russe, Chbb:HM, SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik.
- Age at study initiation: No data
- Weight at study initiation: 2.1-2.4 kg
- Housing: Individually in stainless steel cages
- Diet: Ssniff K4 (rabbit diet), Ssniff, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: At least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23.01.1995 to 06.02.1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³ - Duration of treatment / exposure:
- Four hours
- Observation period:
- 13 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal, 6 cm²
- % coverage: No data
- Type of wrap if used: patch under semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean over 24, 48 and 72 hours
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- In all three animals grade 2 erythema was observed by 30-60 minutes after patch removal. This began to reverse in one animal by day 6, and was completely reversed in all animals by day 13. Grade 4 edema was observed in 2/3 animals 30-60 minutes after patch removal. By 24 hours this had begun to reverse in one animal, and in all animals by 48 hours. All signs of irritation were reversed in all three animals by day 13.
- Other effects:
- Dry skin and desquamation were observed in all animals after approximately one week.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are met, classification with Category 2 (irritant) is required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a skin irritation study conducted according to OECD 404 and in compliance with GLP (reliability score 1) dimethoxydiphenylsilane was irritating to the skin of rabbits.
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