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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

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

Test material

1
Chemical structure
Reference substance name:
5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-6H-pyrido(2,3-b)(1,4)benzodiazepin-6-one monohydrochloride
EC Number:
812-545-9
Cas Number:
93173-05-8
Molecular formula:
C19H21N5O2 x HCl
IUPAC Name:
5,11-dihydro-11-((4-methyl-1-piperazinyl)acetyl)-6H-pyrido(2,3-b)(1,4)benzodiazepin-6-one monohydrochloride
Test material form:
solid: bulk

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
Dose 1 : 0.1 mL/plaque Dose 2 : diltution 1/2 dose 1Dose 3 : diltution 1/2 dose 2
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Details on test system and experimental conditions:
Method of incorporation on a plaque with and without metabolic activation withmicrosomal fraction of rat liver (S9) and preincubation at 37"C during 20minutes. Following the one recommended by Ames (Maroon, D. M. And N. N.Ames, 1983. Revised Method for the Salmonella mutagenicity test. MutationRes., 113, 173-215)

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:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
According to the values of the spontaneous reversion of the strains TA 1535,TA1537, TA98, TA100, with and without the microsomal fraction S"9, theproduct analysed does not induce the reversion of the strains, so that:The sample analysed is considered NON MUTAGENIC with the doses whichcould be tested.