Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of information:
experimental study planned
Justification for type of information:
OECD 473 shows cytotoxicity and chromosome aberation. Therefore, according to Regulation (EC) No. 1907/2006 an OECD 475 study is required.

- Available GLP studies
no studies avaible for the substance

- Available non-GLP studies
no studies avaible for the substance

- Grouping and read-across
no studies avaible for possible read across substances

- Historical human data
no historical human data avaible

- (Q)SAR
out of prediction range, Regulation requires in vivo study

- In vitro methods
Regulation requires in vivo study

- Weight of evidence
not possible based on data lacking

- Substance-tailored exposure driven testing [if applicable]
n.a.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
no

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
Details on test material:
UL03475

Results and discussion

Applicant's summary and conclusion