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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD or GLP study defined.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Reference Type:
other: Microfiche
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
bacterial reverse mutation assay (e.g. Ames test)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) phosphate
EC Number:
201-116-6
EC Name:
Tris(2-ethylhexyl) phosphate
Cas Number:
78-42-2
Molecular formula:
C24H51O4P
IUPAC Name:
tris(2-ethylhexyl) phosphate
Details on test material:
no further data

Method

Target gene:
ames assay: detection of base pair substitutions and frameshift mutations
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:
Negative control: 0 µg/plate
TOF: 12500 µg/plate
TOF: 2500 µg/plate
TOF: 500 µg/plate
TOF: 100 µg/plate
TOF: 20 µg/plate
Positive control Endoxan: 435 µg/plate (only TA 1535 and TA 100)
Positive control Trypaflavin: 200 µg/plate (only TA 1537 and TA 98)
Positive control 2-Aminoantrazen: 10 µg/plate
Vehicle / solvent:
DMSO for TOF, Trypaflavin and 2-Aminoantrazen.
Mineral free water for Endoxan.
Controls
Untreated negative controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
IUCLID 4 Type: Ames test

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

In doses up to 12500 µg/plate no bacteria-toxic effects could be observed.

Applicant's summary and conclusion

Executive summary:

The test substance was tested in the Ames test in doses up to 12500 µg/plate in 4 Salmonella typhimurium strains (TA 1535, TA 100, TA 1537, and TA 98). The positive controls Endoxan, Trypaflavin and 2 -Aminoanthrazen were tested positive, but the test substance Disflamoll TOF showed no mutagen effects.