Registration Dossier

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,7-bis(4-hydroxy-3-methoxyphenyl)heptane-3,5-dione
EC Number:
900-021-3
Molecular formula:
3,5-Heptanedione-1-(4-hydroxy-3-methoxyphenyl)-7-(4-hydroxyphenyl) :C20 H22O5, 3,5-Heptanedione-1,7 -bis(4-hydroxyphenyl) : C19H20O4, 3,5-Heptanedione-1,7-bis(4-hydroxy-3-methoxyphenyl) : C21H24O6
IUPAC Name:
1,7-bis(4-hydroxy-3-methoxyphenyl)heptane-3,5-dione
Test material form:
solid: crystalline

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535
Remarks:
S. typhimurium TA 100
Metabolic activation:
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
Remarks on result:
other: Non Mutagenic

Applicant's summary and conclusion

Conclusions:
Bacterial Reverse Mutation Test in Salmonella typhimurium Tester strains for substance confirms it is non-mutagenic .
The study is performed in compliance with OECD guidelines No.471.