Dimethylamine

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: similar to guideline study; no data regarding GLP

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals

Author:

Zeiger E. et al

Year:

1987

Bibliographic source:

Environ. Mutagen. 9, Suppl. 9, 1-110, (1987)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142

Principles of method if other than guideline:

Use of S. typhymurium strain TA98, TA100, TA1535, TA1537 and/or TA97, but no E.coli strain.
not toxic chemicals tested up to a maximum dose of 10 mg/plate, poorly soluble chemicals were tested up to the dose defined by solubility, A maximum of 0.05 ml solvent was added to each plate, only 2-Aminoanthracene was used as the indicator of the efficacy of the S9-Mix, not every individual plate count is displayed, no justification that no confirmation of the negative result has been made

GLP compliance:

no

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

Molecular formula:

C2H7N

IUPAC Name:

N-methylmethanamine

Details on test material:

Dimethylamine, no further data

Method

Target gene:

his-

Species / strain

Species / strain / cell type:

S. typhimurium, other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, TA97

Metabolic activation:

with and without

Metabolic activation system:

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

Test concentrations with justification for top dose:

0.000, 33.000, 100.000, 333.000, 1000.000, 3333.000, 4500.000 µg/plate

Vehicle / solvent:

H2O

Controls

Untreated negative controls:

not specified

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:

no data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

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: negative

Dimethylamine was considered not mutagenic in the tests performed.

Executive summary:

This test was performed according to Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142 with Salmonella typhimurium TA1535, TA1537, TA98, TA100, and TA 97. The concentrations of the test substance ranged from 0.000, 33.000, 100.000, 333.000, 1000.000, 3333.000 and 4000.000 or 4500.000 µg/plate using the pre-incubation method in either the presence or absence of 10% rat or hamster liver metabolic activation. The highest in some strains nontoxic dose tested was 1000.000 mg/plate and the test result was negative according to all strains, with and without metabolic activation. (Zeiger et al., 1987).