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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1997
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
5-acetyl-10,11-dihydro-3-nitro-5H-dibenz[b,f]azepine
EC Number:
279-251-5
EC Name:
5-acetyl-10,11-dihydro-3-nitro-5H-dibenz[b,f]azepine
Cas Number:
79752-03-7
Molecular formula:
C16H14N2O3
IUPAC Name:
1-{5-nitro-2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaen-2-yl}ethan-1-one
Specific details on test material used for the study:
3-Nitro-5-Acetyl Iminodibenzyl

Method

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:
The enzymatic for metabolism activation (S9 mix) was prepared according to Manufacturer procedure: Regensys A has been completed by the addition of Regensys B, then 5 ml of S9 have been added to obtain a S9 mix solution at 10%.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
cyclophosphamide
mitomycin C
other: Daunomycin, 2 Aminoantracene
Details on test system and experimental conditions:
The whole essay was performed in triplicate.

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
On the basis of the results interpreted according to OECD 471:1997, the substance 3-Nitro-5-Acetyl Iminodibenzyl tested as recommended by standards, proved to be NOT MUTAGENIC for all the test strains, either in the presence or absence of metabolic activation.
Executive summary:

The bacterial reverse mutation assay was performed on five mutant strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100, TA 102).

The presumed mutagenic activity of the test substance was determined by comparing number of reverting colonies in treated cultures with the number of the reverting organisms in the control cultures.

The direct incorporation method in a plate was used both in the presence of, and without, an enzymatic system for metabolic activation.

The test substance was prepared as solution in water with a concentration equivalent to 50 mg/ml and 4 different concentrations of semi-log intervals between them were prepared.

On the basis of the results interpreted according to OECD 471: 1997, the test substance 3-Nitro-5-Acetyl Iminodibenzyl tested as recommended by standards, proved to be NOT MUTAGENIC for all the test strains, either in the presence or absence of metabolic activation.