Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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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
Study period:
short-term in vitro test
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Purity of test substance not given, but study design according to current recommendations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dechlorane Plus, no further details reported, purity not reported

Method

Target gene:
histidine dependence/independence reverting from his- to his+
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538
Additional strain / cell type characteristics:
other: Additional mutations rfa, bio, and uvrB, partly plasmid pKM101
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix, arochlor-induced
Test concentrations with justification for top dose:
0, 10, 50, 100, 500, 1000, 5000, 10000 µg/plate
Vehicle / solvent:
DMSO (concentration not reported) in cell culture medium
Controls
Untreated negative controls:
yes
Remarks:
cell culture medium
Negative solvent / vehicle controls:
yes
Remarks:
cell culture medium with DMSO
True negative controls:
yes
Remarks:
solvent control
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-anthramine
Remarks:
only 2.anthramine with and without metabolic activation, others without metabolic activation
Details on test system and experimental conditions:
The test was repeated once, for each strain and concentration with and without metabolic activation in both tests, two plates each were evaluated, the plates were incubated for 72 hours
Evaluation criteria:
dose-related increase of mutation frequency
Statistics:
none

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No increase in the frequency of mutations in any strain at any concentration with and without metabolic activation, negative and vehicle controls were clearly negative, and positive controls were clearly positive, no cytotoxicity and no precipitations observed.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Dechlorane Plus (µg/plate)              TA 1535              TA 1537              TA 1538                  TA 98                     TA 100

- S9                     10                     42       42              15       10              21       24              24       30             141       133

- S9                     50                     36       27              17       16              17       17              25       17              146       147

- S9                     100                   39       50              17       19              18       15              32       30              152       146

- S9                     500                   37       35              17       21              13       19              26       27              154       139

- S9                     1,000               46       30              14       17              29       18              35       35              154       138

- S9               5,000                41       34              20       09              22       16              31       21              144       152

+ S9                     10                     22       16              26       33              41       34              45       51              136       128

+ S9                     50                     18       19              29       33              43       35              50       64              137       132

+ S9                     100                   27       20              25       36              48       38              57       44              147       133

+ S9                     500                   18       16              32       39              40       33              44       36              155       152

+ S9                     1,000               22       17              27       27              32       40              41       38              124       140

+ S9                     5,000               32       23              22       19              38       33              41       46              152       128

Repeat study

- S9                      50                     23       18              06       06              19       16              15       35              141       99 

- S9                     100                    26       14              06       11              15       13              32       26              139       117

- S9                     500                    29       20              08       06              10       08              30       45              116       107

- S9                     1,000                 18       19              10       07              12       06              30       31              116       125

- S9                     5,000                 29       21              14       08              16       18              29       25              111       104

- S9                     10,000               37       20              12       09              16       15              42       38              117       110

+ S9                     50                     20       16              23       12              38       14              56       48              134       105

+ S9                     100                   30       11              27       20              45       10              66       30              134       105

+ S9                     500                   31       10              19       17              40       18              66       53              117       92

+ S9                     1,000               30       08              16       18              33       22              73       70              128       114

+ S9                     5,000               14       08              16       13              40       25              55       62              110       93

+ S9                     10,000              16       10              18       18              44       27              56       45              107       106

Applicant's summary and conclusion

Conclusions:
negative: no mutagenic effect observed

not mutagenic with and without metabolic activation
Executive summary:

Dechlorane Plus was tested in a standard Ames plate incorporation assay in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538 with and without metabolic activation by rat liver S9 -mix at concentrations up to 10,000 µg/plate. All plates were prepared in duplicate. The test was independently repeated once. No mutagenic effect and no cytotoxicity was observed in any strain at any concentration with and without metabolic activation, no precipitation was reported. Dechlorane Plus was essentially nonmutagenic in this test.