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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 May - 15 July, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide
EC Number:
643-078-7
Cas Number:
87855-59-2
Molecular formula:
C11 H22 N2 O2 Si Si(CH3)(CH=CH2)[N(CH2CH3)(C(=O)CH3)]2
IUPAC Name:
N-[ethenyl(N-ethylacetamido)methylsilyl]-N-ethylacetamide
Test material form:
solid: compact
Details on test material:
Identification: ZMATNo.4094103, supplied as Dow Coming® 1-6008
Source: Korea Biogen Co" Ltd" 690 Sinduk-Ri, SungnamMyuan, Chunan-City, Chungnam, 330-893, Korea
Description: Amber liquid
Lot Number: 091217
Purity: 77.9% ± 0,3 area %
Stability of Test Item: Stable under storage conditions.
Expiry Date: December 26, 20 I 0
Stability of Test Item dilution: The test item formulated in acetone-d6 appeared to be stable at concentrations of 50% and unstable at
I % within 30 minutes of preparation. Degradation at 10% and 5% was also noticeable.
Storage Conditions: At room temperature (range of 20 ± 5 QC), light protected.
Kept away from sources water or humid air.
Safety Precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone-d6
Concentration / amount:
Concentrations at initial irritation screen (I): 100% (undiluted), 75%, 50%, 25% and acetone d-6 alone.
At induction, the test group was treated with the test item at 50% in acetone d-6 and the control group with acetone d-6 only.
At challenge, both test and conlrol group animals were treated with the test item at 1 % and 5% in acetone d-6 as well as with acetone d-6 alone.
Concentrations at initial irritation screen (2): 15%, 10%, 5% and 1 % in acetone d-6.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone-d6
Concentration / amount:
Concentrations at initial irritation screen (I): 100% (undiluted), 75%, 50%, 25% and acetone d-6 alone.
At induction, the test group was treated with the test item at 50% in acetone d-6 and the control group with acetone d-6 only.
At challenge, both test and conlrol group animals were treated with the test item at 1 % and 5% in acetone d-6 as well as with acetone d-6 alone.
Concentrations at initial irritation screen (2): 15%, 10%, 5% and 1 % in acetone d-6.
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in acetone d-6
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in acetone d-6
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: 1% in acetone d-6 . No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% in acetone d-6
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% in acetone d-6
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: 5% in acetone d-6. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% acetone d-6
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: 100% acetone d-6. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% acetone d-6
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: 100% acetone d-6. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
no visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: no visible change.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
discrete or patchy erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
No. with + reactions:
14
Total no. in group:
20
Clinical observations:
no visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: no visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
discrete or patchy erythrema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: ALPHA-HEXYLCINNAMALDEHYDE at 5% in PEG 300. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: discrete or patchy erythrema.

Any other information on results incl. tables

Viability / Mortality / Macroscopic Findings

There were no deaths during the course of the study, hence no necropsies were performed.

Skin Reactions in the Induction

No skin effect was observed in the control group after treatment with acetone d-6 during the

three weeks of induction.

Discrete/patchy erythema was observed in 85% of the test animals after treatment with the test

item at 50% in acetone d-6 during the first week: of induction. Discrete/patchy erythema was

observed in all test animals during the second and third weeks of induction.

Skin Reactions in the Challenge

No skin reactions were observed in neither the control nor test animals after treatment with the

test item at 1 % and 5% in acetone d.6, or with acetone d-6 alone.

The control and test animals were depilated three hours prior to the 24-hour reading to facilitate

the reading of the skin reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance did not exhibit the ability to induce dermal sensitization in guinea pigs when used as such,
Executive summary:

The purpose of this skin sensitizing study was to assess the .ability of test item, ZMA T No.

4094103, to induce delayed contact hypersensitivity when administered topically to albino

guinea pigs.

For this purpose the "Buehler Test" modified by Ritz, H.L. and Buehler, E.V. (1980) was used.

Twenty male animals of the test group were treated topically with ZMATNo. 4094103 at 50% in

acetone d·6 once a week for a 3·week induction phase. The ten animals of the control group

were treated in the same way as the test animals with the vehicle (acetone d-6) only. Two weeks

aller the final induction application the control and test animals were challenged with the test

item at I % and 5% in acetone d-6 as well as with acetone d-6 alone.

No skin reactions were recorded in neither the control nor test groups after topical challenge with

ZMA T No, 4094103 at 1 % and 5% in acetone d·6 or with acetone d·6 alone.

Under the conditions of this study, ZMAT No, 4094103 did not exhibit the ability to induce

dermal sensitization in guinea pigs when used as such,