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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

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:
Ethylenediamine, propoxylated
EC Number:
500-035-6
EC Name:
Ethylenediamine, propoxylated
Cas Number:
25214-63-5
Molecular formula:
(C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
IUPAC Name:
Ethylenediamine, propoxylated
Details on test material:
Name: Ethylenediamine, propoxylated mw 480 (NLP)
Physical state: clear, yellowish viscous liquid
Purity: > 99%

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA1035, 100, 98, 1037 and E.coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9, Aroclor 1254 induced
Test concentrations with justification for top dose:
20 - 5000 µg/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Remarks:
water
Negative solvent / vehicle controls:
not specified
Positive controls:
yes
Positive control substance:
other: MNNG, 9-aminoacridine, 4-NOPD and 4-NQO (in absence of S9) and 2-aminoanthracene (in presence of S9)
Details on test system and experimental conditions:
ADMINISTRATION
- Dosing: 0, 20, 100, 2500 and 5000 µg/plate.
- Number of plates: 3/dose or control
- Application: The test material was prepared in water.
- Positive and negative control groups and treatment:
Negative control: water
Positive controls dissolved in DMSO

- in absence of S9:
MNNG 5 µg/plate (TA1535, 100)
9-aminoacridine 100 µg/plate (TA1537)
4-NOPD 10 µg/plate (TA98)
4-NQO 5 µg/plate (E.coli)


- in presence of S9:
2-aminoanthracene 2.5 µg/plate (TA100, 1535, 1537, 98)
and 60 µg/plate E.coli;

- Pre-incubation time: 48 - 72 hours at 37°C
Evaluation criteria:
A reproducible, dose-related increase (e.g. 2-fold) in the revertant count in at least one strain of bacteria.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA1035, 100, 98, 1037 and E.coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: > 2500 µg/plate
Additional information on results:
GENOTOXIC EFFECTS:
No increase in reverse mutation rate in any strain tested with or without metabolic activation. All positive controls showed an appropriate increase in reverse mutation rate.

PRECIPITATION CONCENTRATION: No precipitation observed.

CYTOTOXIC CONCENTRATION: Very slight decrease in the number of revertants was occasionally observed depending of the strain and test conditions at doses >= 2500 µg/plate.

TEST-SPECIFIC CONFOUNDING FACTORS: None

Remarks on result:
other: other: Salmonella typhimurium TA1035, 100, 98, 1037 and E.coli WP2 uvrA
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
According to the results of the present study, Ethylenediamine, propoxylated was not mutagenic in Salmonella typhimurium/E.coli reverse mutation assay under the experimental conditions chosen.