Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)

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:
6,6'-(1-phenylethane-1,2-diyl)bis(6H-dibenzo[c,e][1,2]oxaphosphinine) 6,6'-dioxide
EC Number:
823-458-0
Cas Number:
1631149-46-6
Molecular formula:
C32H24O4P2
IUPAC Name:
6,6'-(1-phenylethane-1,2-diyl)bis(6H-dibenzo[c,e][1,2]oxaphosphinine) 6,6'-dioxide
Test material form:
solid: particulate/powder

Method

Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
other: 2-Aminoantracene,nitrofurantoine,4-Nitro-1,2-phenilendiammine

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:
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:
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:
cytotoxicity
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
On the basis of the results obtained, it can be concluded that, under the test conditions applied, the test item “HTP- 6123 (DIDOPO),batch n' 20161215, is considered not to be mutagenic under the 1.58 mg/plate concentration.