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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2002-07-01 until 2002-08-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In vivo data from 2002 available.

Test material

Constituent 1
Chemical structure
Reference substance name:
(Chloromethyl)methoxydimethylsilane
EC Number:
700-268-5
Cas Number:
18143-33-4
Molecular formula:
C4 H11 Cl O Si
IUPAC Name:
(Chloromethyl)methoxydimethylsilane
Details on test material:
- Name of test material (as cited in study report): Silane 434099 VP
- Substance type: intermediate
- Physical state: liquid
- Stability under test conditions: pure: stable, in Water: hydrolysis in water with formulation of methanol
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 350-390 g
- Housing: semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
cotton seed oil
Challenge
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
No. of animals per dose:
10 in main study
Details on study design:
RANGE FINDING TESTS:
3 Animals were intradermally treated with 1% and 5% concentration of the test items. No signs of irritation or systemic toxiocity occured. 2 Animals were topically treated with 50% as well as 100 % for 24 and 48 h respectively. No signs of irritation and systemic toxicity were observed.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 7days
- Test groups: pure substance or TS 5% in Cotton seed oil
- Control group: cotton seed oil
- Site: shoulder region
- Frequency of applications: days 0, 6 and 7
- Duration: intradermally and dermally 48h occlusive
- Concentrations: 5% in cotton seed oil


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: beginning on day 20 for 3 days
- Exposure period: 24 h
- Test groups: pure substance
- Control group: cotton seed oil
- Site: shoulder region
- Concentrations: pure
- Evaluation (hr after challenge): 24, 48, and 72 h

Positive control substance(s):
yes
Remarks:
Mercaptobezothiazole, CAS number 149-30-4

Results and discussion

Positive control results:
The reliability control worked as expected (test report)

In vivo (non-LLNA)

Resultsopen allclose all
Hours after challenge:
24
Group:
test chemical
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 24.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Hours after challenge:
48
Group:
test chemical
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 48.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Hours after challenge:
72
Group:
test chemical
Dose level:
pure substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 72.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
15%
No. with + reactions:
6
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not sensitizing to the skin.
Executive summary:

A guinea pig maximization test on (Chloromethyl) methoxydimethylsilane according to OECD 406 did not show any sensitizing effects nor any sign of toxicity or irritation when applied.