2-chlorobutane

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:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study without detailed documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

reliability scoring based on 1997 guideline.

Deviations:

yes

Remarks:

Salmonella typhimurium TA102 or Escherichia coli-WP2 uvrA strain not tested; 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sec-Butylchloride

IUPAC Name:

Sec-Butylchloride

Test material form:

other: colourless liquid

Details on test material:

- Name of test material (as cited in study report): Sec-butylchlorid
- Physical state: Liquid
- Analytical purity: Not reported
- Storage condition of test material: 4°C

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 (compound used to induce CYP450 not reported)

Test concentrations with justification for top dose:

8, 40, 200, 1000 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: see Table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation

DURATION
- Exposure duration: 48 hours at 37 °C

NUMBER OF REPLICATIONS: 4 plates per strain and dose; two independent experiments performed.

Evaluation criteria:

A reproducible and dose related increase in the number of mutant counts for at least one strain is considered positive. For TA 100, TA 98 and TA 1535 a two fold increase of revertants compared to the negative controls should be reached, whereas for TA 1537 a threefold increase should be reached. Otherwise the results are deemed to be negative.

Statistics:

Revertant colony numbers were calculated as average and standard deviation. No statistical analysis was performed.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

(5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES WITH STRAIN TA100:
Test concentration: 19.5, 39, 78, 156, 312, 625, 1250, 2500, 5000 and 10000 µg/plate
No bacterial toxicity was observed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

There was no indication of a bacteriotoxic effect of Sec-butylchloride in all of the employed doses. The total bacteria counts consistently produced results comparable to the negative controls (i.e. vehicle controls). An inhibition of bacterial growth was not noted. 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

No evidence of mutagenic activity of sec-butylchlorid was found.

Executive summary:

No evidence of mutagenic activity of sec-butylchlorid was found. In this study four strains (TA98, TA100, TA1535 and TA1537) were tested with and without metabolic activation (S9 -mix) in concentrations up to 5000 µg/plate.