Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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

Referenceopen allclose all

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 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 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

Reference
Name:
Unnamed
Type:
Constituent
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:
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:
- Vehicle(s)/solvent(s) used: water
Controls
Negative controls:
not specified
Solvent 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 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:
no
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
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.

Applicant's summary and conclusion