Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05.10.1994 to 04.11.1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Sex of animals not given, some environmental conditions not given.
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxyisobutylsilane
EC Number:
402-810-3
EC Name:
Triethoxyisobutylsilane
Cas Number:
17980-47-1
Molecular formula:
Hill formula: C10H24O3Si CAS formula: C10H24O3Si
IUPAC Name:
triethoxy(2-methylpropyl)silane
Details on test material:
- Name of test material (as cited in study report): Isobutyltriethoxysilane
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 309-577 g
- Housing: Groups of 1 to 6 in propylene boxes.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 05.10.1994 to 04.11.1994

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: sesame oil
Concentration / amount:
Induction injection: 5%
Epicutaneous applications: 30%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
Induction injection: 5%
Epicutaneous applications: 30%
No. of animals per dose:
Test: 20
Negative control: 10
Positive control: 10
Details on study design:
RANGE FINDING TESTS: Approximately 24 hours prior to the preliminary test, fur was removed from both flanks by shaving. There was no abrasion. Two guinea pigs were used in a preliminary study to determine the non-necrotic intradermal concentration of the test substance in sesame oil. A volume of 0.1 ml of the test substance at concentrations of 1.25, 2.5 and 5% was injected intradermally on the flank of each guinea pig. No necrosis was observed at any concentration. Therefore the concentration of 5% was selected for the intradermal induction.

Two guinea pigs were used to determine the maximum subirritant concentration and the irritating concentration under occlusive conditions. 0.5 ml of 100, 75, 50 and 30% w/w concentrations of test substance were applied on patches to the flank under occlusion for 24 hours. The maximum subirritant concentration was found to be 30%, while at 100% the test substance was found to be mildly irritating. Therefore these two concentrations were used for the epidermal challenge and epidermal induction, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
On Day 1, two intradermal injections of 5% test substance in sesame oil and 1:1:1 mix of saline:FCA:30% w/w test substance in sesame oil were made on the shaved cervical area (5x5 cm) of each animal. On Day 8, 2 ml of test substance was applied epicutaneously to the same site on a patch and occluded for 48 hours. The control group was treated in the same way without the application of the test substance.

B. CHALLENGE EXPOSURE
Three weeks after the last induction, test and control groups were challenged on one flank with a 30% w/w solution of test substance in sesame oil. A volume of 0.5 ml of solution was applied on a patch to the shaved flank and occluded for 24 hours with Micropore Tape. The skin reactions were scored according to Draize.
Challenge controls:
30% w/w solution of test substance in sesame oil under occlusion for 24 hours.
Positive control substance(s):
yes
Remarks:
DNCB

Study design: in vivo (LLNA)

Statistics:
None

Results and discussion

Positive control results:
10/10 animals reacted positively. Twenty-four hours after patch removal the mean irritation score was 4.6, and at 48 hours, the mean irritation score was found to be 4.0.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1% in peanut oil
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1% in peanut oil
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30% in sesame oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30% in sesame oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30% in sesame oil
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Grade 1 erythema after 24 hours in one animal.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% in sesame oil. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Grade 1 erythema after 24 hours in one animal. .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30% in sesame oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

No mortalities, clinical signs of toxicity or effects on body weight were observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guinea pig maximisation study conducted to OECD 406, but not to GLP, triethoxyisobutylsilane was not sensitising to the skin (reliability score 2).