Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1-propanamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro DNA damage and/or repair study

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

peer reviewed publication

Justification for type of information:

For detailed justification see summary

Data source

Reference

Reference Type:

publication

Title:

Genotoxic activity and potency of 135 compounds in the Ames reversion test and in a bacterial DNA-repair test.

Author:

De Flora, S., Zanacchi, P., Camoirano, A., Bennicelli, C., Badolati, G.S.

Year:

1984

Bibliographic source:

Mutation Research 133: 161-198

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test

Principles of method if other than guideline:

Procedure similar to those described by Kada et al. (1980) in the rec-assay system with B. subtilis and by McCarroll et al. (1981a) with various strains of E. coli.

GLP compliance:

not specified

Type of assay:

other: in vitro DNA damage and/or repair study with E. coli

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol

EC Number:

200-578-6

EC Name:

Ethanol

Cas Number:

64-17-5

Molecular formula:

C2H6O

IUPAC Name:

ethanol

Test material form:

liquid

Details on test material:

No details specified

Method

Species / strain

Species / strain / cell type:

E. coli, other: WP2, WP67, CM871

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

3-methylcholanthrene

4-nitroquinoline-N-oxide

9,10-dimethylbenzanthracene

benzo(a)pyrene

cyclophosphamide

methylmethanesulfonate

Results and discussion

Test results

Key result

Species / strain:

E. coli, other: WP2, WP67, CM871

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

Additional information on results:

Ethanol (H3) also induced a direct DNA damage in E. coli, though extremely weak. Clearly, accurate chemical analyses should be performed to rule out the presence of DNA-damaging impurities in the products used, prior to considering ethanol as genotoxic agent.

Applicant's summary and conclusion

Conclusions:

Ethanol was not mutagenic to E. coli strains in this DNA repair test.