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Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
EC number: 700-770-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- from 2010-12-06 to 2011-01-11 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been conducted according to the standard guideline(s) and its results are acceptable for assessment and classification. The study has not been conducted fully according to GLP. It was conducted in a facility operating to GLP within the UK national GLP monitoring programme and it was Quality Assurance audited to verify the integrity of the data and to ensure the report accurately reflects the data. The analytical characterisation of the test material has been performed according to GLP. As a consequence, the overall reliability rating (according to Klimisch et al.) is considered to be between "reliable without restrictions" and "reliable with restrictions", but closer to "reliable without restrictions". Thus an overall Klimisch rating of 1 (reliable without restrictions) has been assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Principles of method if other than guideline:
- - The study was based on the in vitro technique described by Ames and his co-workers and Garner et al in which mutagenic activity is assessed by exposing histidine and tryptophan auxotrophs of Salmonella typhimurium and Escherichia coli to various concentrations of a test item.
- The dose range for the main experiment was determined in a preliminary toxicity assay.
- In the main experiment, six strains were tested (TA98, TA100, TA1535, TA1537, WP2uvrApKM101, WP2pKM101
- Each bacterial strain was treated with each concentration of test item in triplicate both with and without S9-mix in Experiment I and with S9-mix only in Experiment II.
- The plate incorporation method was used for Experiment I and the preincubation method for Experiment II. - GLP compliance:
- no
- Remarks:
- Conducted in a facility operating to GLP within the UK national GLP monitoring programme. Audited by Quality Assurance to verify the integrity of the data and to ensure the report accurately reflects the data. Analysis of test item according to GLP.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- EC Number:
- 700-770-4
- Molecular formula:
- C12H14Cl2O2
- IUPAC Name:
- Reaction mass of (1R,4S,4aR,8R,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8S,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1R,4S,4aR,8S,8aS)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one and (1S,4R,4aS,8R,8aR)-9-(dichloromethylidene)-8-hydroxyoctahydro-1,4-methanonaphthalen-5(1H)-one
- Details on test material:
- - Physical state: Light beige powder
- Stability under test conditions: not reported
- Storage condition of test material: Room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine locus of the genom of the bacterium for Salmonella typhimurium
Tryptophan locus of the genom of the bacterium for Escherichia coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: E. coli WP2 strain used: E. coli WP2 pKM101
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate metabolising system (10% liver S9 in standard co-factors)
- Test concentrations with justification for top dose:
- Preliminary toxicity test, with and without S9: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate
Experiment I, without S9: 15, 50, 150, 500, 1500, 5000 µg/plate
Experiment I, with S9: 15, 50, 150, 500, 1500, 5000 µg/plate
Experiment II, with S9: 5, 15, 50, 150, 500, 1500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: dimethyl sulphoxide (for vehicle controls, positive controls, test item formulation)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: N-ethyl-N'-nitro-N-nitrosoguanidine (TA100, TA1535, WP2uvrA pKM101 , WP2pKM101), 4-nitroquinoline-1-oxide (TA98), 9-aminoacridine (TA1537). With S9: 2-aminoanthracene (TA100, TA1535, WP2uvrA pKM101 , WP2pKM101, TA1537), benzo(a)pyrene (TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation)
Experiment II: preincubation
DURATION
- Preincubation period: 60 minutes (37°C, Experiment II only)
- Exposure duration: incubation at 37°C for approx. 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY:
- Method (preliminary toxicity test):
concentrations tested: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate;
after approx. 48 hours incubation at 37°C the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn. Manual counts were performed at 5000 μg/plate because of excessive test item precipitation.
MEASUREMENT OF FREQUENCY OF REVERTANT COLONIES:
by means of a Domino colony counter or (in case of excessive test item precipitation) by manual counts - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice the colony count of the corresponding solvent control is observed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Mainly at the highest dose level(s). For details see "ADDITIONAL INFORMATION ON CYTOTOXICITY" under "Additional information on results".
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Mainly at the highest dose level(s). For details see "ADDITIONAL INFORMATION ON CYTOTOXICITY" under "Additional information on results".
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A test item precipitate (fibrous in appearance) was noted at 5000 µg/plate in both experiments. This observation did not prevent the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES: Strain TA100 and WP2uvrApKM101 were treated with concentrations from 0 to 5000 µg/plate with and without metabilic activation. The results are presented in "Any other information on results incl. tables".
COMPARISON WITH HISTORICAL CONTROL DATA: The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test item was toxic to both of the strains of bacteria used (TA100 (presence and absence of S9-mix) and WP2uvrApKM101 (absence of S9-mix only)) at 5000 μg/plate (the test item formulation and S9-mix used in this experiment were both shown to be sterile).
In the first experiment (plate incorporation methodology) the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains dosed in the absence of S9-mix at 5000 µg/plate. In the presence of S9-mix, weakened bacterial background lawns were noted for TA100, TA98 and TA1537 at 5000 µg/plate with substantial reductions in revertant colony frequency noted at the same dose level for TA1535, WP2uvrApKM101 and WP2pKM101. In the second experiment (pre-incubation methodology) the test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains, initially from 1500 µg/plate (TA100) and at 5000 µg/plate (TA1535, TA98 and TA1537). There was no visible reduction in the viability of the bacterial background lawns of Escherichia coli strains WP2uvrApKM101 and WP2pKM101, however slight reductions in colony frequency were noted. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Increases in the frequency of revertant colonies
No toxicologically significant increases in the frequency of revertant colonies, in excess of two‑fold greater than the concurrent solvent controls, were recorded for any of the bacterial strains, for any dose level of the test item, either with or without metabolic activation.
Preliminary Toxicity Test
The numbers of revertant colonies for the toxicity assay were:
With (+) or without (-) |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
87 |
93 |
84 |
95 |
90 |
86 |
84 |
78 |
95 |
85 |
0 VP |
+ |
TA100 |
102 |
106 |
113 |
120 |
102 |
121 |
122 |
103 |
113 |
87 |
0 VP |
- |
WP2uvrA |
140 |
155 |
158 |
154 |
135 |
134 |
144 |
151 |
134 |
137 |
85 SP |
+ |
WP2uvrA |
173 |
166 |
161 |
201 |
173 |
170 |
177 |
180 |
188 |
184 |
130 P |
S Sparse bacterial background lawn
V Very weak bacterial background lawn
P Precipitate
Test Results: Experiment 1 – Without Metabolic Activation
Test Period |
From: 13 December 2010 |
To: 16 December 2010 |
|||||||||||
With or Without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||
TA100 |
TA1535 |
WP2uvrA |
WP2pKM101 |
TA98 |
TA1537 |
||||||||
- |
0 |
102 107 103 |
(104) 2.6# |
26 20 27 |
(24) 3.8 |
203 197 198 |
(199) 3.2 |
81 81 99 |
(87) 10.4 |
22 22 23 |
(22) 0.6 |
11 7 16 |
(11) 4.5 |
- |
15 |
82 90 96 |
(89) 7.0 0.9 |
20 27 20 |
(22) 4.0 0.9 |
177 206 197 |
(193) 14.8 1.0 |
103 92 97 |
(97) 5.5 1.1 |
15 15 18 |
(16) 1.7 0.7 |
12 14 12 |
(13) 1.2 1.2 |
- |
50 |
101 101 93 |
(98) 4.6 0.9 |
15 26 20 |
(20) 5.5 0.8 |
195 214 189 |
(199) 13.1 1.0 |
85 113 81 |
(93) 17.4 1.1 |
24 20 16 |
(20) 4.0 0.9 |
14 12 15 |
(14) 1.5 1.3 |
- |
150 |
98 89 106 |
(98) 8.5 0.9 |
26 26 23 |
(25) 1.7 1.0 |
186 188 201 |
(192) 8.1 1.0 |
89 101 82 |
(91) 9.6 1.0 |
19 18 20 |
(19) 1.0 0.9 |
11 11 11 |
(11) 0.0 1.0 |
- |
500 |
86 92 96 |
(91) 5.0 0.9 |
29 24 24 |
(26) 2.9 1.1 |
200 179 198 |
(192) 11.6 1.0 |
81 81 78 |
(80) 1.7 0.9 |
21 16 21 |
(19) 2.9 0.9 |
14 15 11 |
(13) 2.1 1.2 |
- |
1500 |
117 75 101 |
(98) 21.2 0.9 |
24 23 29 |
(25) 3.2 1.0 |
190 176 217 |
(194) 20.8 1.0 |
67 74 75 |
(72) 4.4 0.8 |
15 18 16 |
(16) 1.5 0.7 |
11 8 9 |
(9) 1.5 0.8 |
- |
5000 |
69 SP 78 SP 81 SP |
(76) 6.2 0.7 |
0 VP 0 VP 0 VP |
(0) 0.0 0.0 |
126 SP 172 SP 77 SP |
(125) 47.5 0.6 |
56 SP 31 SP 45 SP |
(44) 12.5 0.5 |
0 VP 0 VP 0 VP |
(0) 0.0 0.0 |
0 VP 0 VP 0 VP |
(0) 0.0 0.0 |
Positive controls |
Name |
ENNG |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
||||||
S9-Mix - |
Concentration (μg/plate) |
3 |
5 |
0.5 |
2 |
0.2 |
80 |
||||||
No. colonies per plate |
449 346 454 |
(416) 61.0 |
1212 1052 1290 |
(1185) 121.3 |
1486 1709 1784 |
(1660) 155.0 |
1784 1597 1730 |
(1704) 96.2 |
140 150 157 |
(149) 8.5 |
2203 2882 2046 |
(2377) 444.3 |
ENNG N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
S Sparse bacterial background lawn
V Very weak bacterial background lawn
P Precipitate
0.0 Fold increase over concurrent vehicle control
# Standard deviation
Test Results: Experiment 1 – With Metabolic Activation
Test Period |
From: 13 December 2010 |
To: 16 December 2010 |
|||||||||||
With or Without |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||
TA100 |
TA1535 |
WP2uvrA |
WP2pKM101 |
TA98 |
TA1537 |
||||||||
+ |
0 |
103 91 99 |
(98) 6.1# |
16 15 11 |
(14) 2.6 |
252 286 231 |
(256) 27.8 |
135 130 128 |
(131) 3.6 |
30 23 24 |
(26) 3.8 |
14 11 15 |
(13) 2.1 |
+ |
15 |
90 82 93 |
(88) 5.7 0.9 |
15 12 12 |
(13) 1.7 0.9 |
242 227 210 |
(226) 16.0 0.9 |
98 123 136 |
(119) 19.3 0.9 |
27 21 30 |
(26) 4.6 1.0 |
14 16 14 |
(15) 1.2 1.2 |
+ |
50 |
79 80 74 |
(78) 3.2 0.8 |
10 14 12 |
(12) 2.0 0.9 |
222 217 213 |
(217) 4.5 0.8 |
115 133 130 |
(126) 9.6 1.0 |
33 22 19 |
(25) 7.4 1.0 |
14 8 13 |
(12) 3.2 0.9 |
+ |
150 |
91 74 84 |
(83) 8.5 0.8 |
16 9 23 |
(16) 7.0 1.1 |
232 206 269 |
(236) 31.7 0.9 |
118 122 115 |
(118) 3.5 0.9 |
22 23 25 |
(23) 1.5 0.9 |
12 12 13 |
(12) 0.6 0.9 |
+ |
500 |
86 104 80 |
(90) 12.5 0.9 |
16 15 12 |
(14) 2.1 1.0 |
229 236 253 |
(239) 12.3 0.9 |
114 115 121 |
(117) 3.8 0.9 |
29 22 23 |
(25) 3.8 1.0 |
10 13 14 |
(12) 2.1 0.9 |
+ |
1500 |
95 86 99 |
(93) 6.7 0.9 |
3 8 3 |
(5) 2.9 0.4 |
199 199 224 |
(207) 14.4 0.8 |
93 97 117 |
(102) 12.9 0.8 |
22 25 21 |
(23) 2.1 0.9 |
12 7 8 |
(9) 2.6 0.7 |
+ |
5000 |
47 SP 65 SP 67 SP |
(60) 11.0 0.6 |
0 P 0 P 0 P |
(0) 0.0 0.0 |
196 P 179 P 157 P |
(177) 19.6 0.7 |
68 P 67 P 64 P |
(66) 2.1 0.5 |
0 VP 0 VP 0 VP |
(0) 0.0 0.0 |
10 SP 10 SP 8 SP |
(9) 1.2 0.7 |
Positive controls |
Name |
2AA |
2AA |
2AA |
2AA |
BP |
2AA |
||||||
S9-Mix + |
Concentration (μg/plate) |
1 |
2 |
10 |
10 |
5 |
2 |
||||||
No. colonies per plate |
574 668 548 |
(597) 63.1 6.1 |
120 147 165 |
(144) 22.7 10.3 |
2106 2191 2232 |
(2176) 64.3 8.5 |
500 435 472 |
(469) 32.6 3.6 |
361 308 299 |
(323) 33.5 12.4 |
122 122 122 |
(122) 0.0 9.4 |
BP Benzo(a)pyrene
2AA 2-Aminoanthracene
S Sparse bacterial background lawn
V Very weak bacterial background lawn
P Precipitate
0.0 Fold increase over concurrent vehicle control
# Standard deviation
Test Results: Experiment 2 – With Metabolic Activation & Pre-Incubation
Remark: due to constraints of this IUCLID field it was not possible to include this table. The complete "Any other information on results incl. tables of endpoint study record" can be found in attachment DCHK-NBA_Ames_add_info.pdf.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item was considered to be non-mutagenic under the conditions of this test.
This study has been initiated (study initiation date: 24 November 2010) for other purposes than to support a registration according to Regulation (EC) No 1907/2006 (REACH). It has not been carried out in compliance with the principles of good laboratory practice (GLP), which is, according to REACH Article 13 (4), required for toxicological tests. The study has been conducted according to the standard guideline(s). It was conducted in a facility operating to GLP within the UK national GLP monitoring programme and it was Quality Assurance audited to verify the integrity of the data and to ensure the report accurately reflects the data. The original data and the original final report are retained in the archives of the test facility. No formal claim of GLP compliance has been made for this study. The analytical characterisation of the test material has been performed according to GLP.
After assessing all information on this study, the registrant has concluded that the following conditions are met:
(1) adequacy for the purpose of classification and labelling and/or risk assessment;
(2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);
(3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and
(4) adequate and reliable documentation of the study is provided.
Thus, according to REACH Annex XI, 1.1 ("Testing does not appear scientifically necessary - Use of existing data"), these existing data are considered to be acceptable for fulfilling the information requirements of this endpoint.
As a consequence, the overall reliability rating (according to Klimisch et al.) is considered to be between "reliable without restrictions" and "reliable with restrictions", but closer to "reliable without restrictions". Thus an overall Klimisch rating of 1 (reliable without restrictions) has been assigned. - Executive summary:
This study was designed to assess the mutagenic potential of test item using a bacterial/microsome test system. The study was based on the in vitro technique described by Ames.
The bacterial strains S. typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2uvrApKM101 and WP2pKM101 were treated with the test item at up to seven dose levels in triplicate. In experiment I, the plate incorporation method was followed and cultures with and without S9 mix were tested. In experiment II, the preincubation method was followed and only cultures with S9 mix were tested. The solvent, untreated and positive controls were also tested in triplicate.
The sensitivity of the assay and the efficacy of the S9-mix were validated by the results obtained for the solvent and positive controls.
In the first experiment (plate incorporation methodology) the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains dosed in the absence of S9-mix at 5000 µg/plate. In the presence of S9-mix, weakened bacterial background lawns were noted for TA100, TA98 and TA1537 at 5000 µg/plate with substantial reductions in revertant colony frequency noted at the same dose level for TA1535, WP2uvrApKM101 and WP2pKM101. In the second experiment (pre-incubation methodology) the test item caused a visible reduction in the growth of the bacterial background lawns of all of the Salmonella tester strains, initially from 1500 µg/plate (TA100) and at 5000 µg/plate (TA1535, TA98 and TA1537). There was no visible reduction in the viability of the bacterial background lawns of Escherichia coli strains WP2uvrApKM101 and WP2pKM101, however slight reductions in colony frequency were noted. The test item was tested up to the maximum recommended dose level (5000 µg/plate). A test item precipitate (fibrous in appearance) was noted at 5000 µg/plate in both experiments. This observation did not prevent the scoring of revertant colonies.
No toxicologically significant increases in the frequency of revertant colonies, in excess of two‑fold greater than the concurrent solvent controls, were recorded for any of the bacterial strains, for any dose level of the test item, either with or without metabolic activation.
In conclusion, the test item was considered to be non-mutagenic under the conditions of this test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.