Registration Dossier
Registration Dossier
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EC number: 242-171-6 | CAS number: 18293-82-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 01.03.1993 to 19.03.1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The original study was reliability 1. Read across to the registered substance is considered to be scientifically justified and is reliability 2. The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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:
- Trimethoxy(2-methylpropyl)silane
- EC Number:
- 242-272-5
- EC Name:
- Trimethoxy(2-methylpropyl)silane
- Cas Number:
- 18395-30-7
- IUPAC Name:
- isobutyl(trimethoxy)silane
- Details on test material:
- - Name of test material (as cited in study report): Dynasylan IBTMO (isobutyl(trimethoxy)silane)
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Stable for < 1 year
- Storage condition of test material: controlled humidity in closed container.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: Only stated to be adults
- Weight at study initiation: 2.2-2.5 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 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: 01.03.1993 to 19.03.1993
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:
- 17 days
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not stated
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: Four hours
SCORING SYSTEM: Draize, and OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritant / corrosive response data:
- 30-60 minutes after patch removal, animals had clearly defined erythema and oedema (moderate in one animal, severe in two animals). After 24 and 48 hours skin redness remained unchanged, but oedema had reduced (clearly defined in one animal, moderate in two animals). After 72 hours each animal had clearly defined or moderately severe erythema and oedema. After 6 and 8 days two animals had barely perceptible irritation, and one animal had clearly defined erythema and oedema. After 10 and 14 days all animals had barely perceptible redness and swelling. By day 17 all irritation had reversed.
- Other effects:
- In addition to the erythema and oedema described above, there was some scaly and shedded skin by days 10 and 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation study conducted according to OECD 404 and to GLP (reliability score 1), Dynasylan IBTMO (isobutyl(trimethoxy)silane) was irritating to the skin of small white Russian rabbits.
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