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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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:
july to september 2002
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
pre llna time

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane
EC Number:
300-344-4
EC Name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane
Cas Number:
93925-42-9
Molecular formula:
C12H24O4Sn.C8H20O4Si
IUPAC Name:
Acetic acid, 1,1'-(dibutylstannylene) ester, reaction products with silicic acid (H4SiO4) tetra-Et ester

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
cotton seed oil
Concentration / amount:
induction state: 0.1 %
challenge state: 100 %
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
cotton seed oil
Concentration / amount:
induction state: 0.1 %
challenge state: 100 %
No. of animals per dose:
10 for test, 10 positive control, 5 negative control
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
15 % mercaptobenothiazole
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 15 % mercaptobenothiazole. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: erythema.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
15 % mercaptobenothiazole
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 15 % mercaptobenothiazole. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: erythema.
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
positive control
Dose level:
15 % mercaptobenothiazole
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 15 % mercaptobenothiazole. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: erythema.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
n.a.
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
n.a.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: n.a.. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: n.a..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
n.a.
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
n.a.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: n.a.. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: n.a..
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
n.a.
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
n.a.
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: n.a.. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: n.a..
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
n.a.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: n.a..
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
n.a.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: n.a..
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
n.a.
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: n.a..

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No of the test animals showed a sensitising reaction to the test item.