2-chloro-2-methylpropane

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions Deficiencies: limited testing of positive controls, no details of test system and no evaluation criteria stated in the report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Ames et al., Mutation Research 31/6, 347-364 (1975)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloro-2-methylpropane

EC Number:

208-066-4

EC Name:

2-chloro-2-methylpropane

Cas Number:

507-20-0

Molecular formula:

C4H9Cl

IUPAC Name:

2-chloro-2-methylpropane

Method

Species / strain

Species / strain / cell type:

other: TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

10, 100, 250, 500 and 1000 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

other: limited measurements performed with strain TA 100

Positive control substance:

benzo(a)pyrene

Details on test system and experimental conditions:

not stated in the report

Evaluation criteria:

not stated in the report

Results and discussion

Test results

Species / strain:

other: TA 1535, TA 1537, TA 1538, TA 98, TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

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 metabolic activation
negative without metabolic activation

Under conditions tested, the test item did not induce gene mutations by base pair changes or frame-shifts in the genome of the tester strains used.
Thus, the test item is considered non-mutagenic in this bacterial reverse mutation assay.