Triethylamine

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no E. coli strain included

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:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Triethylamine

EC Number:

204-469-4

EC Name:

Triethylamine

Cas Number:

121-44-8

Molecular formula:

C6H15N

IUPAC Name:

triethylamine

Details on test material:

Triethylamine, no further data

Method

Target gene:

his-

Species / strain

Species / strain / cell type:

other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, TA97

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

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

Test concentrations with justification for top dose:

0, 100, 333, 1000, 3333 and 10000 ug/plate

Vehicle / solvent:

95% ethanol

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

was run with each trial

True negative controls:

not specified

Positive controls:

yes

Remarks:

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

Positive control substance:

not specified

Details on test system and experimental conditions:

SYSTEM OF TESTING
- Species/cell type: Salmonella typhimurium TA 100, TA 1535, TA1537, TA 98
- Deficiency: histidine
- Solvent: 95% ethanol
- Metabolic activation system: rat and hamster S9 (10% Aroclor  1254-induced)

ADMINISTRATION: 
- Dosing: 0, 100, 333, 1000, 3333 and 10000 ug/plate 
- Number of replicates: 3
- Application: plate incubation
- Positive and negative control groups and treatment:  without S9: Sodium azide (TA1535, TA100), 9-aminoacridine (TA1537),  4-nitro-o-phenylenediamine (TA98) with S9: 2-aminoanthracene
- Pre-incubation time: 20 minutes

DESCRIPTION OF FOLLOW UP REPEAT STUDY: If initial test was equivocal or  negative, repeat with other level of S9. 

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

Species / strain:

S. typhimurium, other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>10000 ug/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other:

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 236. TRIETHYLAMINE (LAB: SRI   VOLVENT: ET95)
DOSE	TA100												TA1535
	NA		NA		10% HLI		10% HLI		10% RLI		10% RLI		NA		10% HLI		10% RLI
µg/plate	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	125	1.0	104	4.6	160	12.8	117	5.3	142	5.8	127	9.9	32	1.8	35	4.3	24	1.3
100.000	114	7.3	117	9.7	125	9.5	123	3.2	127	6.5	112	8.6	30	4.1	26	2.6	22	1.3
333.000	133	9.6	115	15.3	147	0.6	158	4.7	127	11.8	113	2.7	24	2.2	30	3.5	24	1.5
1.000.000	110	4.1	113	14.8	138	7.0	128	11.3	125	17.3	111	8.2	32	4.8	33	10.5	18	2.0
3.333.000	112	5.2	92	7.2	140	6.9	138	14.7	119	14.5	89	3.2	21	3.8	42	5.2	17	2.1
10000.000	t		t		129	0.9	t		120	31.5	t		t		t		4	2.1
POS	277	18.4	419	12.6	1100	18.7	778	10.2	688	39.0	335	6.4	379	22.3	356	53.3	120	13.2

 

Table 236. TRIETHYLAMINE (CONTINUED)
DOSE	TA1537						TA98
	NA		10% HLI		10% RLI		NA		10% HLI		10% RLI
µg/plate	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM	MEAN	SEM
0.000	6	0.6	7	0.7	15	1.2	18	3.8	26	2.9	33	4.0
100.000	8	1.0	6	0.6	9	0.3	29	4.5	35	5.1	26	5.4
333.000	8	1.9	6	0.7	6	0.3	18	2.0	32	5.8	26	2.7
1000.000	5	0.6	9	3.2	9	1.5	19	1.5	24	2.4	29	1.2
3333.000	6	0.6	8	0.7	5	1.9	12	1.3	34	3.9	15	4.5
10000.000	t		3	2.0	2	0.5	t		t
POS	211	25.1	454	17.6	204	14.8	730	18.6	457	34.3	401	33.1

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Triethylamine do not revert mutations in the Salmonella typhimurium.

Executive summary:

Salmonella typhimurium TA 100, TA 1535, TA1537, TA 98 were exposed to 0, 100, 333, 1000, 3333 and 10000 µg/plate  using the pre-incubation method in either the presence or absence of 10% rat or hamster liver metabolic activation. The highest nontoxic dose tested was 3333 mg/plate (32.94 mmol/plate).