Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: guidelines for microbial mutagenicity testing as set forth by various international regulatory authorities (e.g., OECD, 1981; US EPA, 1982; US FDA, 1993).
Version / remarks:
this testing protocol complies fully with (or exceeds) proposed revised testing guidelines developed by the Organisation for Economic Co-operation and Development (Gatehouse, et al., 1994) and the International Conference on Harmonisation (ICH, 1995, 1997).
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,4,5-trichloro-6-carbopentoxyphenyl) oxalate
EC Number:
250-195-3
EC Name:
Bis(2,4,5-trichloro-6-carbopentoxyphenyl) oxalate
Cas Number:
30431-54-0
Molecular formula:
C26H24Cl6O8
IUPAC Name:
pentyl 2,3,5-trichloro-6-[(2-oxo-2-{3,4,6-trichloro-2-[(pentyloxy)carbonyl]phenoxy}acetyl)oxy]benzoate
Constituent 2
Chemical structure
Reference substance name:
Butyl benzoate
EC Number:
205-252-7
EC Name:
Butyl benzoate
Cas Number:
136-60-7
Molecular formula:
C11H14O2
IUPAC Name:
butyl benzoate
Test material form:
liquid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
at doses of 5.00, 16.7, 50.0, 167, 500 and 1670 nl/plate under plate incorporation treatment conditions, and at doses of 1.67, 5.00, 16.7, 50.0, 167 and 500 nl/plate under liquid pre-incubation treatment conditions
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
other: ENNG for WP2 uvrA, without S9; 2-Aminofluorene for TA102, with S9, 2-anthramine for others with S9

Results and discussion

Test results
Key result
Species / strain:
other: S. typhimurium tester strains (TAI535, TA1537, TA98, TAIOO and TA 102), and in E. coli strain WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Inhibited growth or complete toxicity again was observed in all six tester strains at the highest 1-4 doses evaluated under both treatment conditions with and without S9.
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
True negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The test item is considered to be negative in the Ames/Salmonella-E. coli Reverse Mutation Assay, under the conditions, and according to the criteria, of the test protocol.