1,3-dimethylurea

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure according to National Standards (NTP)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: II. Results From the Testing of 270 Chemicals

Author:

Mortelsmans K et al.

Year:

1986

Bibliographic source:

Environmental Mutagenesis 8 (Suppl. 7), 1-119

Reference 2

Reference Type:

publication

Title:

1,3-Dimethylurea (CAS: 96-31-1), SIDS Initial assessment report for SIAM 17

Author:

OECD SIDS

Year:

2009

Bibliographic source:

Unep publications

Report date:

2003

Reference 3

Reference Type:

secondary source

Title:

Unnamed

Year:

2001

Materials and methods

Principles of method if other than guideline:

Method: other: Preincubation test according to Haworth et al., Environ. Mutagen. 5 (Suppl.1), 3-142, (1983) and Zeiger E. and Drake J.W., IARC Scientific Publ. No. 27, 303-313, (1980)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethylurea

EC Number:

202-498-7

EC Name:

1,3-dimethylurea

Cas Number:

96-31-1

Molecular formula:

C3H8N2O

IUPAC Name:

1,3-dimethylurea

Details on test material:

- Name of test material (as cited in study report): 1,3-Dimethylurea (CAS: 96-31-1)
- Analytical purity: purity 98%

Method

Target gene:

his

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA97

Metabolic activation:

with and without

Metabolic activation system:

1254 Aroclor induced rat and hamster liver

Test concentrations with justification for top dose:

0; 0.10; 0.33; 1.0; 3.3; 10 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: see any other information on materials and methods

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

Evaluation criteria:

A dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold, was evaluated as a "mutagenic response". When no increase in the number of revertants was elicited by the chemical, this was evaluated a "negative response" and when there was an absence of a clear-cut dose-related increase in revertants, when the dose-related increase in the number of revertants were not reproducible or when the response was of insufficient magnitude to support a determination of mutagenicity, this was evaluated a "questionable response".

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

 1,3-dimethylurea was negative in these tests and the highest ineffective dose tested in any S. typhimurium strain was 10 mg/plate.