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Toxicological information

Genetic toxicity: in vitro

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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
Study period:
from 1989-10-12 to 1989-12-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD N°471 Guideline (1983 May 26th)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethylethylamine (DMEA)
- Physical state: liquid
- Analytical purity: 99.54%
- Purity test date: 1989-07-20
- Lot/batch No.: 8907P0193
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stable under standard conditions
- Other: origin: Usine La Chambre

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix from Aroclor 1254-induced rat liver (10%)
Test concentrations with justification for top dose:
100, 500, 1000, 2500, 5000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: solubility
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: sodium azide (TA100, TA1535), 2-nitrofluorene (TA98, TA1538), 9-aminoacridine (TA1537). +S9: 2-aminoanthracene (all strains)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20minutes at 37°C (0.1mL of the test item solution + 0.5mL of phosphat e buffer 0.2M or S09mix + 0.1mL of bacteria)
- Fixation time (start of exposure up to fixation or harvest of cells): 48hours

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, number of revertant colonies
Evaluation criteria:
dose dependent increase in the number of revertant colonies
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 2500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under these experimental conditions, DMEA is not mutagenic in S.typhimurium in Ames test.
Executive summary:

The genotoxic activity of Dimethylethylamine DMEA is evaluated in the Ames test on Salmonella typhimurium according to the OECD 471 guideline. Doses of 100, 500, 1000, 2500, 5000 ug/plate are tested on five strains (TA 98, TA 100, TA 1535, TA 1537 and TA 1538) according to the preincubation method (20 min at 37°C). The number of revertants colonies is evaluated 48 to 72 hours later.

Cytotoxicity was observed for the highest dose (5000µg/plate) with and without metabolic activation in all strain. No genotoxic activity was observed for all doses with and without metabolic activation on the 5 tested strains.

In conclusion, Dimethylethylamine did not induce genotoxicity in the Ames test on Salmonella typhimurium in the absence and presence of metabolic activation.