Registration Dossier
Registration Dossier
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EC number: 236-948-9 | CAS number: 13560-89-9
Genetic toxicity: in vitro
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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene
- EC Number:
- 236-948-9
- EC Name:
- 1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene
- Cas Number:
- 13560-89-9
- Molecular formula:
- C18H12Cl12
- IUPAC Name:
- 1,2,3,4,7,8,9,10,13,13,14,14-dodecachloro-1,4,4a,5,6,6a,7,10,10a,11,12,12a-dodecahydro-1,4:7,10-dimethanodibenzo[a,e][8]annulene
- Details on test material:
- Dechlorane Plus, no further details reported, purity not reported
Constituent 1
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.
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