2,2'-methyliminodiethanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Method according to Ames et al (1975)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-methyliminodiethanol

EC Number:

203-312-7

EC Name:

2,2'-methyliminodiethanol

Cas Number:

105-59-9

Molecular formula:

C5H13NO2

IUPAC Name:

2-[(2-hydroxyethyl)(methyl)amino]ethan-1-ol

Method

Target gene:

histidine gene

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

Type and composition of metabolic activation system:
- source of S9 : S9 liver homogenate, isolated from Aroclor 1254 induced rat

Test concentrations with justification for top dose:

0.1, 0.3, 1, 3, 5, 10 mg/plate

Vehicle / solvent:

water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without S9 mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S9 mix

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitrophenylenediamin

Remarks:

without S9 mix

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracen

Remarks:

with S9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: inhibition of growth of the background lawn

Evaluation criteria:

At least twice the solvent control for at least one concentration and there was evidence of a concentration-related increase in the number of revertant colonies.

Statistics:

no data

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

-S9 mix: from 3 mg/plate onwards; +S9-mix: at 10 mg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No mutagenic activity was observed in any of the 5 strains mutants over the range of concentrations tested in the absence or the presence of S9 activation, either by evidence of a dose-response relation or a doubling of the mean number of colonies over the vehicle control value.

Any other information on results incl. tables

Table 1: Results:

Chemical		TA98		TA100		TA1535		TA1537		TA1538
	Dose (mg/plate)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
water	100	22±5	14±5	123±24	127±27	10±2	11±2	7±2	6±2	8±2	11±4
4 -NPD	0.01	683±43	-	-	-	-	-	-	-	794±50	-
NaN3	0.01	-	-	1087±60	-	917±194	-	-	-	-	-
9 -AA	0.06	-	-	-	-	-	-	240±33	-	-	-
2 -AA	0.0025	-	1890±34	-	1757±164	-	123±10	-	299±6	-	1655±109
MDEA	0.1	26±3	21±6	87±13	124±17	15±12	11±4	11±6	5±2	8±1	13±3
MDEA	0.3	19±4	18±1	113±20	104±4	13±5	13±3	4±2	5±3	12±3	10±4
MDEA	1	18±3	19±0	106±13	102±6	10±4	11±2	6±3	5±2	8±1	13±5
MDEA	3	22 (s)	15±2	80±6	101±16	8 (s)	5±2	4±2	4±2	7 (T)	10±4
MDEA	5		15±3		100±11		11±1		3±1		16±1
MDEA	10	toxic		toxic		toxic		toxic		toxic

4-NPD: 4-nitrophenylenediamine;

NaN3: sodium azide;

9-AA: 9-aminoacridine;

2-AA: 2-aminoanthracene.

 

Toxic: clearing of background lawn or average number of colonies less than half of the solvent control value.

S: sparse growth of background lawn in one or two of the triplicates tested. Counts not included in the calculation of mean and standard deviations not calculated.

T: toxic to one or two of the triplicates tested.

No mutagenic activity was observed in any of the 5 strains mutants over the range of concentrations tested in the absence or the presence of S9 activation, either by evidence of a dose-response relation or a doubling of the mean number of colonies over the vehicle control value.