Registration Dossier

Administrative data

Description of key information

There are no skin sensitisation studies available for the registered substance itself.

In accordance with Column 2 of REACH Annex VII, the in vivo skin sensitisation study (required in Annex VII Section 8.3) does not need to be conducted as the available information indicates that the substance meets the criteria for classification as corrosive to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2004-01-12 to 2004-02-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no reliability check reported
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, Borchen, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: 300-500g
- Housing: in groups in Terluran cages
- Diet: standard diet: ad libitum
- Water: drinking water ad libitum
- Acclimation period: described as adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h

IN-LIFE DATES: From: To: not stated but within the period 2004-01-12 to 2004-02-13
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% for induction and challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% for induction and challenge
No. of animals per dose:
20 test, 10 controls
Details on study design:
RANGE FINDING TESTS: 50% (in corn oil) and 100% tested on 2 animals for irritancy

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: left flank
- Frequency of applications: 3 applications at weekly intervals
- Duration: exposure duration 6h
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the final induction
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48h

Challenge controls:
Negative but no concurrent positive control or reliability data provided. A reliability check was to be conducted in the future (BSL 040619).
Positive control substance(s):
no
Remarks:
reliability check was to be conducted in the future (BSL 040619)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
no treatment
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
no treatment
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
other: not included
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: not included

No response was recorded at any time point in the test or control groups.

Interpretation of results:
GHS criteria not met
Conclusions:
A well conducted, well reported Buehler sensitization test reported that a 100% concentration of the test material failed to induce a sensitization response in guinea pigs when challenged with the same neat test material. Appropriate concurrent negative controls were included, but the positive compliance test was to be undertaken at a later date.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no skin sensitisation studies available for methylsilanetriyl triacetate itself. However, two relevant in vivo skin sensitisation studies are available as supporting information. In the first test (BSL, 2004), a preparation containing a mixture of approximately 4.5% (total) methylsilanetriyl triacetate (described as triacetoxymethylsilane in the test report) and the related substance triacetoxyethylsilane was found to be not sensitising in a test conducted according to the Buehler method. In a second test (Hazelton Laboratories, 1990), a preparation containing approximately 5% methylsilanetriyl triacetate (described as triacetoxymethylsilane in the test report) was not sensitising, also using the Buehler method. These preparations are similar to products marketed for professional and consumer sealant applications and the studies therefore indicate that there is no sensitisation potential from use of the preparations.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on in vivo tests with preparations containing methylsilanetriyl triacetate, the registered substance is not classified for skin sensitisation under Regulation (EC) No 1272/2008.