Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
other: in vivo: Guinea pig maximisation test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
july to september 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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:
other: OECD 406
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OPPTS 870.2600
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU B.6
Deviations:
no
GLP compliance:
yes
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany

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

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: positive and negative control
Duration of treatment / exposure:
48h
Observation period:
72h
Number of animals:
10

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
the test item showed in the sensitization study no irritant properties