Butanenitrile, 2-amino-2,3-dimethyl-

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: Meets generally accepted scientific standards, is well documented and is accepted for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Reference 2

Reference Type:

secondary source

Title:

Robust Summary for Aminoalkylnitrile Category

Author:

US EPA HPVIS

Year:

2006

Bibliographic source:

Doc ID 201-16274

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-2,3-dimethylbutanenitrile

Cas Number:

13893-53-3

Molecular formula:

C6H12N2

IUPAC Name:

2-amino-2,3-dimethylbutanenitrile

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

with and without Aroclor induced rat liver S-9 (50 ml/plate S-9 preparation)

Test concentrations with justification for top dose:

Preliminary test: 1000 and 5000 µg/plate.
Main test: 0.1, 1, 10, and 100 µg/plate (0.1 µl test substance per plate)

Controls

Negative solvent / vehicle controls:

yes

Remarks:

ethanol solvent control

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (2-AA), N-methyl-N-nitro- N-nitrosoguanidine (MNNG), 9-aminoacridine (9-AA), and 2- nitrofluorene (2-NF)

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:

cytotoxicity

Remarks:

1000 and 5000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

2-amino-2,3-dimethylbutanenitrile was non-mutagenic in the Ames Salmonella Plate Assay with and without metabolic activation (S-9) using bacterial strains TA-98, TA-100, TA-1535, and TA-1537. The maximum 2-amino-2,3-dimethylbutanenitrile concentration tested was 5,000 µg/plate. 2-amino-2,3-dimethylbutanenitrile was cytotoxic at 5,000 and 1,000 µg/plate. The assay was repeated using 2-amino-2,3-dimethylbutanenitrile concentrations of 0.1, 1, 10, and 100 µg/plate. No evidence of base-pair substitution or frame-shift mutation was seen. Details see table 1.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Overview of revertants per plate after treatment of bacteria with test substance, solvent and positive controls.

Strain	S9 -Mix	Number of revertants in vehicle control	Maximal number of revertants (dose µg/plate)	Number of revertants in positive control
TA1535	-	10	8 (1 µg/plate)	981 (MNNG)
	+	18	12 (1 µg/plate)	266 (2 -AA)
TA 1537	-	6	9  (1 µg/plate)	575 (9 -AA)
	+	5	6  (1 µg/plate)	197 (2 -AA)
TA 98	-	14	16 ( (0.1 µg/plate)	792 (2 -NF)
	+	22	24  (1 µg/plate)	1226 (2 -AA)
TA 100	-	58	68  (0.1 µg/plate)	1375 (MNNG)
	+	96	96 (0.1 µg/plate)	1705 (2 -AA)