Registration Dossier

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:
06.02.2006 to 09.03.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
1.2 to 5000 µg/plate
Vehicle / solvent:
Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
Positive controls:
yes
Remarks:
TA100; 0.01 µg/plate
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
Remarks:
Without S9 Mix
Positive controls:
yes
Remarks:
TA1535; 0.5 µg/plate
Positive control substance:
sodium azide
Remarks:
Without S9 Mix
Positive controls:
yes
Remarks:
WP2 uvrA; 0.01 µg/plate
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
Without S9 Mix
Positive controls:
yes
Remarks:
TA 98; 0.1 µg/plate
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
Without S9 Mix
Positive controls:
yes
Remarks:
TA 1537: 1.0 µg/plate
Positive control substance:
other: 6-Chloro-9-[3-(2-chloroethylamino )-propylamino ]-2-methoxyacridine dihydrochloride (ICR-191)
Remarks:
Without S9 Mix
Positive controls:
yes
Remarks:
TA 100; 1.0 µg/plate
Positive control substance:
other: 2-Aminoanthracene
Remarks:
With S9 Mix
Positive controls:
yes
Remarks:
TA 1535; 2.0 µg/plate
Positive control substance:
other: 2-Aminoanthracene
Remarks:
With S9 Mix
Positive controls:
yes
Remarks:
WP2 uvrA; 10.0 µg/plate
Positive control substance:
other: 2-Aminoanthracene
Remarks:
With S9 Mix
Positive controls:
yes
Remarks:
TA 98; 0.5 µg/plate
Positive control substance:
other: 2-Aminoanthracene
Remarks:
With S9 mix
Positive controls:
yes
Remarks:
TA 1537; 2.0 µg/plate
Positive control substance:
other: 2-Aminoanthracene
Remarks:
With S9 Mix
Details on test system and experimental conditions:
Method: Preincubation method

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537 and Escherichia coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: 1250 (S. typhimurium) - 5000 (E. coli) µg/plate

Any other information on results incl. tables

Growth inhibition of bacteria induced by the test substance was observed at and above the doses below:

 Bacterial strains

 Without S9 Mix

 With S9 Mix

 TA100  1250 µg/plate  1250 µg/plate
 TA1535  1250 µg/plate  1250 µg/plate
 WP2 uvrA  2500 µg/plate  2500 µg/plate
 TA98  1250 µg/plate   1250 µg/plate
 TA1537  1250 µg/plate  2500 µg/plate

Precipitate of the test chemical was not observed either with or without S9 Mix.

No bacterial growth was detected in the sterility test on the test chemical solution and S9 Mix.

Applicant's summary and conclusion

Conclusions:
Based on these results, it was concluded that 2-chloro-2-methylbutane is not mutagenic under the conditions tested.