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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Salmonella mutagenicity tests. III. Results from the testing of 225 chemicals
Author:
Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K and Speck W
Year:
1987
Bibliographic source:
Environ. Mutagen. Vol. 9 (Suppl 9) 1-109
Reference Type:
other: database
Title:
National Toxicology Progam - Database Search Application
Author:
NTP database
Year:
2011
Bibliographic source:
http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters
Test concentrations with justification for top dose:
0, 33, 100, 333, 1000, 1666, 3333 and 10000 µg/plate (preincubation test)
Vehicle / solvent:
- Vehicle used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 2

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
Dipropylenetriamine did not cause gene mutations in Salmonella typhimurium (Ames test).