Distillation residue, butyl alcohols production, rectification

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010 May 19 to 2010 June 23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline 471 study performed and reported following GLP standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Distillation residue, butyl alcohols production, rectification

EC Number:

931-740-0

Molecular formula:

undefined (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Distillation residue, butyl alcohols production, rectification

Details on test material:

Solvent-still residue of butyl alcohol rectification, Composite sample K-303-III. A composite sample, consisting of 5 sub-samples taken over a period of 3 consecutive days, was collected directly from the process line. The volume of each sub-sample was approximately 5-10 L. The sub-samples were combined, resulting in a total volume of ca. 50 L. This ca. 50 L composite sample was split into two equal portions of ca. 25 L each (control sample and laboratory sample). The ca. 25 L laboratory sample was further split into two portions of ca. 5 L and 20 L before sending for analysis at two separate laboratories. After sampling and sample splitting, all the portions of the composite sample were stored at +4 deg Celsius.

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

Range-finding assay: Test article was freshly prepared in DMS0 and seven concentrations from range 0.0001 - 5.0 mg/plate were tested without and with metabolic activation.
According to the results of range-finding assays (with and without metabolic activation) six tested doses were selected for testing. Concentrations of test product ranged between 0.0001 and 0.1 mg/plate.

Vehicle / solvent:

dimethylsulphoxide (DMSO) (purum) Lot 1104114 (Fluka)

Controls

Untreated negative controls:

yes

Remarks:

dimethylsulphoxide (DMSO)

Negative solvent / vehicle controls:

yes

Remarks:

dimethylsulphoxide (DMSO)

True negative controls:

yes

Remarks:

dimethylsulphoxide (DMSO)

Positive controls:

yes

Remarks:

without activation: sodium azide: TA 1535, 2-nitrofluorene:TA 98, 9-aminoacridine: TA 97, mitomycin C: TA 102. With activation: 2-acetamidofluorene: TA 98.

Details on test system and experimental conditions:

As described in OECD guideline 471.

Evaluation criteria:

Positive results: concentration-related increase over the tested range and reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation. MF>2. Student's test was used for evaluation of statistical significance of mutation frequency increasing against solvent control value.

Statistics:

Data were presented as the number of revenant colonies per plate. The mean numbers of revertant colonies per plate and the standard deviations were presented for the test substance and positive and negative controls.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In experiments without metabolic activation the concentration of 5 mg/plate were toxic against all strains Salmonella typhimurium. In experiments with metabolic activation, the concentrations of 5 and 1 mg/ml decreased the number of revertants.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

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

The Solvent still residue of butyl alcohol rectification in accordance with these results is considered non mutagenic in this system.