N,N-dimethylbutylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study equivalent to guideline

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylamine

EC Number:

204-697-4

EC Name:

Dimethylamine

Cas Number:

124-40-3

IUPAC Name:

N-methylmethanamine

Test material form:

not specified

Method

Target gene:

his-

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:

rat and hamster S9 (10% Aroclor 1254-induced)

Test concentrations with justification for top dose:

0, 33, 100, 333, 1000, 3333, 4500 µg/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

run with each trial

Positive controls:

yes

Remarks:

without S9: Sodium azide (TA1535, TA100), 9-aminoacridine (TA1537), 4-nitro-o-phenylenediamine (TA98) with S9: 2-aminoanthracene

Evaluation criteria:

An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose related
increase was judged insufficiently high to justify a call of " + W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.
The distinctions between a weak mutagenic response and a mutagenic response, or between a weak mutagenic response and a questionable mutagenic response are highly subjective.
A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials. A chemical was considered to be questionable (?) if a reproducible increase of hist revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials

Statistics:

not required

Results and discussion

Test results

Species / strain:

S. typhimurium, other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: >1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 82.1 DIMETHYLAMINE (LAB: EGG   SOLVENT: H2O)
DOSE	TA100						TA1535						TA1537						TA98
	NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI
ug/PLATE	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	93	8.0	89	9.1	76	2.5	24	1.9	8	1.7	13	1.2	4	1.5	4	0.9	8	1.5	18	5.2	20	0.6	24	3.2
33.000	92	5.4					21	1.5					8	1.0					20	2.7
100.000	91	8.7	90	3.1	77	2.0	19	2.5	7	1.5	11	0.9	8	0.6	6	0.9	8	2.6	15	2.8	24	2.2	17	1.0
333.000	92	6.4	80	4.5	91	0.6	20	4.0	10	0.6	10	2.7	5	1.3	6	2.3	6	2.2	17	4.8	20	2.0	17	2.7
1000.000	88	6.3	92	7.0	88	5.2	16	2.3	7	1.2	8	1.7	5	1.5	8	0.3	5	1.7	17	1.2	20	3.9	24	3.0
3333.000	t		88	5.2	89	11.0	11s	1.5	8	1.2	9	1.3	6s	0.7	7	1.5	10	0.3	t		19	5.0	22	1.5
4500.000			82	6.7	86	2.5			9s	1.8	8	2.4			6	1.3	6	3.3			19	1.2	20	1.5
POS	2003	16.5	887	78.0	580	31.2	1176	36.1	80	1.9	51	2.7	573	199.4	94	4.2	58	8.7	840	81.5	1011	82.4	639	64.7

 

Table 82.2 DIMETHYLAMINE (LAB: EGG   SOLVENT: H2O)
DOSE	TA100						TA1535						TA1537						TA98
	NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI		NA		10% HLI		10% RLI
ug/PLATE	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	117	10.1	107	6.2	132	16.2	21	3.5	13	1.5	10	0.7	7	2.0	8	0.9	8	0.6	22	4.4	34	2.9	28	3.2
100.000	126	4.8	124	3.2	106	7.0	14	1.2	10	1.2	15	4.2	8	1.9	8	0.3	9	1.5	25	2.7	25	2.9	28	1.5
333.000	112	9.5	116	5.0	120	0.9	15	3.9	15	1.8	10	0.0	8	1.3	7	1.2	10	2.2	21	1.7	28	1.7	26	1.2
1000.000	126	4.4	136	4.4	127	4.3	18	3.2	10	2.0	10	1.7	5	0.3	5	0.9	9	0.6	22	0.7	29	6.2	31	1.9
2000.000	108	7.6	115	5.1	113	16.4	15s	3.0	12s	1.9	14	1.5	9s	2.8	9	0.3	11	1.7	24s	1.8	26	1.2	27	1.2
3333.000	97s	11.5	129s	4.7	117	14.7	t		11s	1.2	11	1.2	t		7	0.6	8	0.6	20s	1.5	29	2.4	27	1.8
4000.000									16s	2.3
POS	2012	55.2	1503	72.7	1255	49.0	1205	65.2	116	7.2	60	1.7	535	18.1	184	21.0	133	2.1	2002	38.4	1270	40.2	1022	55.2

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Dimethylamine (and all other primary, secondary, and tertiary aliphatic amines tested in this valid study) was not mutagenic in the Ames test, with or without metabolic activation.

Executive summary:

Salmonella typhimurium TA 100, TA 1535, TA1537, TA 98 were exposed to 0, 33, 100, 333, 1000, 3333, 4000, and 45000 µg/plate using the pre-incubation method in either the presence or absence of 10% rat or hamster liver metabolic activation. The highest non-toxic dose was 1000 mg/plate. The number of revertants was not increased in any of the experiments, i.e. dimethylamine was not mutagenic in bacteria (Zeiger et al., 1987).

The study is considered to be valid and suitable for assessment and the result can be extrapolated to N,N-dimethylbutylamine. All other aliphatic amines that were included in this study were also negative. This includes the following substances: allylamine; n-butylamine; sec-butylamine; tert. butylamine; di-allylamine; 1,3-diamonopropane; di-ethylamine; 1,3-dimethylbutylamine; di-n-propylamine; ethyl-n-butylamine; isopropylamine; tri-allylamine; tri-butylamine; tri-ethylamine; tri-isobutylamine.