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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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:
supporting study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions; the applied strains of bacteria may not detect certain oxidising mutagens, cross-linking agents; the negative result was not repeated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
- TA 102 or E.coli WP2 strains are not included; negative results were not repeated
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
449-410-5
EC Name:
-
Cas Number:
18084-64-5
Molecular formula:
C36H44N4
IUPAC Name:
1,4,7,10-Tetrabenzyl-1,4,7,10-tetraazacyclododecane

Method

Target gene:
Histidine gene locus
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced male Wistar rat liver S9 mix
Test concentrations with justification for top dose:
0.01, 0.025, 0.05, 0.1, 0.25, 0.5, 1 , and 2.5mg/plate (6/7 concentrations per strain in the presence and absence of S9 mix); the initial experiments with the tester strains TA1538 and TA98 had to be repeated with lower concentrations in order to obtain an appropriate concentration range;
testing was performed up to toxicity and well into the precipitation range








Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
cyclophosphamide
other: anthracen-2-amine

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
growth inhibition of the background lawn was observed in all strains generally starting at 0.1 mg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
growth inhibition of the background lawn was observed in all strains generally starting at 0.5 mg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Precipitates were found in the agar starting at 0.1 mg/plate

Applicant's summary and conclusion

Executive summary:

The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, 1538 and TA 1537 in the presence and absence of S9 mix in a test protocol generally following OECD TG 471. Deviations from guideline were the absence of a strain which detects cross-linking mutagens (e.g. TA 102) and that the negative result was not verified. Evaluation of the data indicates that the test substance is not a mutagen in the Ames Salmonella/microsome test.