3-(methylamino)propane-1,2-diol

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

Study period:

March 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to international guidelines but not to GLP. Details on the test substance, e.g. lot no. lacking.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-1,2-propanediol

IUPAC Name:

3-amino-1,2-propanediol

Constituent 2

Reference substance name:

3-aminopropane-1,2-diol

EC Number:

210-475-8

EC Name:

3-aminopropane-1,2-diol

Cas Number:

616-30-8

IUPAC Name:

3-aminopropane-1,2-diol

Constituent 3

Reference substance name:

aminopropandiol

IUPAC Name:

aminopropandiol

Details on test material:

- Name of test material (as cited in study report): 3-amino-1, 2-propandiol
- physical state - viscous, colourless liquid

Method

Target gene:

Histidine operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Rat liver microsomal fraction (S9 mix)

Test concentrations with justification for top dose:

0.08,0.4, 2.0, 10.0, 50.0 mg/ plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Test substance is highly viscous, diluted 1:1 in distilled water.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: With metabolic activation: 2-aminoanthracene, benzo(a)pyrene. Without metabolic activation: sodium azide, 1-nitropyrene, 2-nitrofluorene, 2-acetylaminofluorene.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation);

DURATION
- Preincubation period: none
- Exposure duration: 2 days

SELECTION AGENT (mutation assays): histifine

NUMBER OF REPLICATIONS: 2 per concentration of test substance

NUMBER OF CELLS EVALUATED: 2x10E8/mL

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth (bacterial lawn).

Evaluation criteria:

A substance is considered mutagenic if it produces in any of the tester strains a statistically significant dose-related increase in the number of mutant colonies and/or a 2-fold increase in the number of mutant colonies compared to the control.

Results and discussion

Test results

Test results 1

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

No mutagenic activity of 3-amino-1, 2-propandiol was detected in any of the tester strains under the conditions used.