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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
The tests were carried out in accordance with the method published by AMES et al., and with the modifications described
by the Ministry of Labour of Japan.
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
EC Number:
280-479-2
EC Name:
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
Cas Number:
83547-95-9
Molecular formula:
C30H57O7PS3
IUPAC Name:
2-ethylhexyl 2-{[bis({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)phosphoryl]sulfanyl}acetate
Test material form:
liquid
Details on test material:
- Other: Trade name D 16-051
Specific details on test material used for the study:
TEST MATERIAL (as stated in study report): TK 12 184; common name D 16-51

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. Mixt. 4/5/6

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction of liver from rats induced with Aroclor 1254
Test concentrations with justification for top dose:
5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 ml. The top dose is the highest dose recommeneded by test guidelines.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-aminoanthracene
Details on test system and experimental conditions:
Each Petri dish contained: 1) approx. 20 ml of minimum agar (Agar, Difco Laboratories, Detroit, Michigan, U.S.A., plus salts (Vogel-Bonner Medium E) and glucose), 2) 0.1 ml of the solution of the test substance or the vehicle and 0.1 ml of a bacterial culture (in nutrient broth, Difco Laboratories, Detroit, Michigan, U.S.A., 0.8% plus 0.5% NaCl) in 2.0 ml of soft agar. The soft agar was composed of: 100 ml of 0.6% agar solution with 0.6% NaCl and 10 ml of a solution of 1-histidine, 0.5 mM (Fluka, Buchs, Switzerland) and +biotin 0.5 mM (Fluka, Buchs, Switzerland). In the experiments in which the substance was metabolically activated, 0.5 ml of an activation mixture was added also.

In the experiments without and with the addition of microsomal activation mixture three Petri dishes were prepared per strain
and per group (i.e. per concentration or per control group).

The plates were incubated for about 48 hours at 37 C in darkness.
Rationale for test conditions:
per referenced methods
Evaluation criteria:
The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.
Statistics:
Arithmetic means were calculated for each test group.

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA1538, TA1535, TA1537, WP2uvra
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
In the experiments performed without and with microsomal activation, comparison of the number of back-mutant colonies in the controls and the cultures treated with the various concentrations of TK 12 184 revealed no marked deviations.

Applicant's summary and conclusion

Conclusions:
Under these standard test conditions, there was no evidence of the induction of point mutations by TK 12 184 in S. typhimurium or E. coli at concentrations up to 5000 µg/plate with and without metabolic activation.