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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
according to guideline
Guideline:
other: EC directive 92/69/EEC, L 383 A: part B: Methods for the Determination of Toxicity - Mutagenicity (Escherichia coli WP2 uvr A - reverse mutation assay) dated 29 December 1992
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrabutylurea
EC Number:
224-929-8
EC Name:
Tetrabutylurea
Cas Number:
4559-86-8
Molecular formula:
C17H36N2O
IUPAC Name:
1,1,3,3-tetrabutylurea
Test material form:
other: liquid

Method

Target gene:
his, trp
Species / strainopen allclose all
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0 - 5000 ug/plate
Vehicle / solvent:
acetone
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
other: 2-aminoanthracene
Details on test system and experimental conditions:
According to guideline
Evaluation criteria:
According to guideline
Statistics:
yes

Results and discussion

Test resultsopen allclose all
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

1,1,3,3-tetrabutylurea was tested negative both in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 as well as in E. coli WP2 uvr A
Executive summary:

1,1,3,3-tetrabutylurea was tested according to EC Guideline B.13/14. and OECD Guideline 471 with GLP compliance both in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 as well as in E. coli WP2 uvr A. Both with and without S9 mix there was no indication for a mutagenic activity.