Ethylenediamine, propoxylated

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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.