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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.03.1993 to 22.03.1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles, and conducted 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 405 (Acute Eye 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: <1 year
- Storage condition of test material: Protect from humidity

Test animals / tissue source

Species:
rabbit
Strain:
other: little white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: No data
- Weight at study initiation: 2.2, 2.4 and 2.6 kg
- Housing: Individual in conventional 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: 15.03.1993 To: 22.03.1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3
Duration of treatment / exposure:
Eyes were washed after 24 hours.
Observation period (in vivo):
Six days
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Barely perceptible signs of irritation after one hour. 24 Hours later there was clearly defined erythema and very slight edema in one animal, but the other two had barely perceptible redness. The eyelids were red in all animals. After 48 hours one animal had barely perceptible redness and swelling of the conjunctiva and reddened eyelids. Another animal had very slight redness of the mucous membranes. After 72 hours the eye of one rabbit was very slightly red and swollen. The other two animals were symptom-free. All animals were symptom-free by six days.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study conducted to a protocol similar to OECD 405, and to GLP (reliability score 1), Dynasylan IBTMO (isobutyltrimethoxysilan) was not irritating to the eyes of small white Russian rabbits. There were some minor signs of irritation involving the conjunctiva, that had reversed by 72 hours in two of the animals and by day 6 in one animal.