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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

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

Constituent 1
Chemical structure
Reference substance name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
EC Number:
816-324-8
Cas Number:
2044770-20-7
Molecular formula:
C19H44N4O2
IUPAC Name:
1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol
Test material form:
liquid

Method

Target gene:
Histidine gene
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
Post-mitochondrial fraction (S9 fraction) from rats treated with Aroclor 1254, prepared according to MARON and AMES (1983) was obtained from Trinova Biochem8. S9 was collected from male rats.
Test concentrations with justification for top dose:
Strains:
5 strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535, TA1537)
Concentrations: 31.6, 100, 316, 1000, 3160 and 5000 μg test item per plate

Plates:
3 per concentration and experiment

Experiments:
2 independent experiments, each with and without metabolic activation

Justification for top dose:
The test item (PU-2017-766) was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at the top concentration of 5000 μg PU-2017-766/plate in both experiments (see tables 1 and 2).
Hence, 5000 μg PU-2017-766 per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
mitomycin C
other: 2-aminoanthracene

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In conclusion, under the present test conditions, the test item tested up to a concentration of 5000 µg/plate (cytotoxic in the preincubation test) caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Executive summary:

In conclusion, under the present test conditions, the test item tested up to a concentration of 5000 µg/plate (cytotoxic in the preincubation test) caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.

Cytotoxicity:

No signs of cytotoxicity were noted in the plate incorporation test without and with metabolic activation up to the top concentration of 5000 μg the test item//plate in any test strain. Cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted in the preincubation test without and with metabolic activation at the top concentration of 5000 μg/plate in all test strains and, in addition, at 3160 μg/plate in test strains TA100 and TA102.

Mutagenicity:

No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to a concentration of 5000 μg/plate (cytotoxic in the preincubation test), in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).

The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.

The results of the negative and positive control cultures are within the range of the historical data generated by the examining laboratory.