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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.

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