Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1997-02-10 to 1997-05-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The data are read across from dichloro(3-chloropropyl)methylsilane (CAS 7787-93-1). The original study was considered reliability 1. Read-across to the registered substance is considered scientifically justified and is reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
0.2, 12.5, 25 µg/ml -S9 mix and 50 µg/ml -S9 mix in test #2. 50, 400 and 600 µg/ml + S9 mix
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
(with activation)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
(without activation)
Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION

- Exposure duration: 3 - 28 hours

- Expression time (cells in growth medium): 15 hours with S9 in exp 1, 18 hours without S9. 28 hours in exp 2.

- Selection time (if incubation with a selection agent): 4 and 7 days

- Fixation time (start of exposure up to fixation or harvest of cells): 18 - 28 hours

SPINDLE INHIBITOR (cytogenetic assays): Colcemid

STAIN (for cytogenetic assays): Giesma

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: 200 cells per treatment group


DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
Evaluation criteria:
The test chemical is considered clastogenic if it induces chromosomal aberrations (excl. gaps) in a statistically significant manner in one or more concentrations; the induced proportion of aberrant cells exceeds the normal range of the test system (i.e. > 5%), and positive results can be verified in an independent experiment.
Statistics:
Chi-square test

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

In a reliable test conducted according to OECD 473 and under GLP, the test substance did not induce biologically significant increases in the chromosomal aberration frequency of V79 Chinese hamster cells and is therefore judged to be non clastogenic in vitro. The result is a read across from dichloro(3-chloropropyl)methylsilane (CAS 7787-93-1).