(3-chloropropyl)dimethoxymethylsilane

Genetic toxicity: in vitro

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

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Dichloro(3-chloropropyl)methylsilane

EC Number:

232-136-3

EC Name:

Dichloro(3-chloropropyl)methylsilane

Cas Number:

7787-93-1

Molecular formula:

C4H9Cl3Si

IUPAC Name:

Dichloro(3-chloropropyl)methylsilane

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

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

(with activation)

Controls 2

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).