2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride

EC Number:

303-085-5

EC Name:

2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride

Cas Number:

94158-14-2

Molecular formula:

C9H11NO3.ClH

IUPAC Name:

2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride

Test material form:

solid: crystalline

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix

Test concentrations with justification for top dose:

33, 100, 333, 1000, 2500 and 5000 µg/plate (highest test concentration recommended by the respective guideline)

Vehicle / solvent:

de-ionized water

Controls

Untreated negative controls:

yes

Remarks:

de-ionized water

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that under the experimental conditions reported HYDROXYETHYL-3,4-METHYLENEANILINE HCL did not induce gene mutations in any of the tester strains in the presence or absence of S9 mix, up to a concentration of 5000 µg/plate.

Executive summary:

HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL,dissolved in de-ionized water, was tested for mutagenicity in the reverse mutation assay (experiment 1: plate incorporation method, experiment 2: pre-incubation method) both with and without metabolic activation (S9 mix from the liver of phenobarbital/ß-naphthoflavone induced male Wistar Hanlbm rats). TheSalmonella typhimuriumstrains TA98, TA100, TA102, TA1535 and TA1537 were exposed to the test substance at concentrations ranging from 33 µg/plate to 5000 µg/plate with and without S9 mix. Test concentrations were selected based on the results obtained in a pre-experiment with strains TA98 and TA100. For control purposes, untreated, solvent (deionized water) and positive controls (without S9 mix: 4-nitro-o-phenylene­-diamine for strains TA98 and TA1537, sodium azide for strains TA100 and TA1535; methyl methane sulfonate for strain TA102; with S9 mix: 2-aminoanthracene for all tester strains) were evaluated in parallel.

Normal background growth was observed up to the highest test concentration of 5000 µg/plate (highest test concentration recommended by the respective guideline) in the presence and absence of S9 mix in all strains investigated. No toxic effects, evident as a reduction in the number of revertants, was noted in any of the five tester strains with and without S9 mix at all concentrations investigated. No biologically relevant increase in revertant colony numbers in any of the five tester strains was observed following treatment withHYDROXYETHYL-3,4-METHYLENEANILINE HCLat any dose level, neither in presence nor in absence of metabolic activation. Reference mutagens revealed a distinct increase in revertant colonies and demonstrated the sensitivity of the assay.