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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01.03.1993 to 19.03.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 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:
1993
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

Constituent 1
Chemical structure
Reference substance name:
Trimethoxy(2-methylpropyl)silane
EC Number:
242-272-5
EC Name:
Trimethoxy(2-methylpropyl)silane
Cas Number:
18395-30-7
Molecular formula:
C7H18O3Si
IUPAC Name:
trimethoxy(2-methylpropyl)silane
Details on test material:
- Name of test material (as cited in study report): Dynasylan IBTMO (isobutyltrimethoxysilan)
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Stable for < 1 year
- Storage condition of test material: controlled humidity in closed container.

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:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2.33
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 17 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2.67
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2.33
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2.11
Max. score:
2.33
Reversibility:
fully reversible within: 17 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 2.67
Max. score:
3
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 scaley 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 (trimethoxy(2-methylpropyl)silane) was irritating to the skin of small white Russian rabbits.