[2-(2-methoxymethylethoxy)methylethoxy]propanol

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:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study, equivalent to OECD Guideline no 473.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Version / remarks:

for the absence of S9positive control was not used.

Deviations:

yes

Remarks:

for the absence of S9, positive control was not used.

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxypropan-2-ol

EC Number:

203-539-1

EC Name:

1-methoxypropan-2-ol

Cas Number:

107-98-2

IUPAC Name:

1-methoxypropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Dowanol PM

- Physical state: clear liquid

Method

Target gene:

Induction of chromosomal damage (clastogenicity).

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

- Type and identity of media: Mc Conys 5A medium supplemented with 15% fetal calf serum and antibiotic ( Penicillin and streptomycin)
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 liver homogenate prepared from AROCLOR 1254 treated Sprague-Dawley rats

Test concentrations with justification for top dose:

1.25, 2.5, 5.0, 10.0 mg/ml

Vehicle / solvent:

the test material was dissolved directly in the culture medium

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Evaluation criteria:

Structural chromosomal abnormalities that were scored included chromatid and chromosome gaps, chromatid breaks and exchanges, chromosome breaks and exchanges, and chromosomal disintegration.  Chromatid and chromosome gaps were not included in the number of total aberrations.

The final interpretation of biological significance of the cytogenetic responses was based on both statistical outcome and sound scientific judgement.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: PM was not toxic to CHO cells up to 5 mg/ml and reduced survival to approximatale 50% at 10 mg/ml.

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Cultures treated with 500 ug/ml cyclophosphamide served as positive controls for activation assays.  Negative control cultures were treated with culture medium (the solvent used to dissolve the test material).  PM was not toxic to CHO cells up to 5 mg/ml and reduced survival to approximatale 50% at 10 mg/ml.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Results are shown in the table below: 

Dose Level    With/without   Cytotoxicity   Aberrations
(ug/ml)        S-9 
------------------------------------------------------
0 Dowanol PM +/-        Negative       Negative
1.25 Dowanol PM +/-        Negative       Negative

2.5 Dowanol P   +/-        Negative       Negative
5.0 Dowanol PM +/-        Negative       Negative

10 Dowanol PM +/ -       slight toxic     Negative
0.5 CP              +         no data           Positive

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Dowanol PM was non-clastogenic to cultured CHO cells under the experimental conditions used.

Executive summary:

Dowanol Propylene glyocl methyl ether (Dowanol PM) was evaluated in an vitro chromosomal aberration assay utilizing Chinese hamster ovary (CHO) cells. The clastogenicity of the test material was assessed in the absence and presence of an externally supplied metabolic activation (S-9) system at dose levels of 1.25, 2.5, 5.0, 10.0 mg/ml of Dowanol Pm. prior to main expiriment a cytotoxicity assay was performed for the dose range finding. Cultures treated with 500 µg/ml cyclophosphamide served as positive controls for the activation assays. Negative control cultures were treated with culture medium (the solvent used to dissolve the test material). There were no statistically significant increases in the frequencies of chromosomal aberrations in cultures treated with the test material either in the absence or presence of of S-9 as compared to the negative conrol cultures. The positive control chemicals induced the epxected increases in aberration frequencies. Hence, under the experimental conditions used,

Dowanol PM was considered to be non-clastogenic to CHO cells in culture.