Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-358-7 | CAS number: 66423-13-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study (OECD TG 471)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate
- EC Number:
- 266-358-7
- EC Name:
- Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate
- Cas Number:
- 66423-13-0
- Molecular formula:
- C18H27ClO3
- IUPAC Name:
- octyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate
- Reference substance name:
- Mecoprop-P n-octyl ester
- IUPAC Name:
- Mecoprop-P n-octyl ester
- Reference substance name:
- Preventol B5
- IUPAC Name:
- Preventol B5
- Reference substance name:
- R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester
- IUPAC Name:
- R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, octyl ester
- Details on test material:
- - Stability under test conditions: A stability test in the solvent did not reveal significant degradation of the active ingredient.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- mutant histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from the liver of Aroclor 1254 induced male Sprague Dawley rats.
- Test concentrations with justification for top dose:
- plate incorporation assay: 0, 50, 158, 500, 1581, 5000 µg/plate with and without S9 mix
preincubation assay: 0, 50, 158, 500, 1581, 5000 µg/tube with and without S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test item formed clear colorless solutions in DMSO.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (TA 1535), nitrofurantoin (TA100), 4-nitro-1,2-phenylene diamine (TA 1535 and TA 98), mitomycin C (TA 102), cumene hydroperoxide (TA102), 2-aminoanthracene (all tester strains with S9 mix)
- Remarks:
- The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C and cumene hydroperoxide were only used without S9 mix; the positive control 2-aminoanthracene was only used with S9 mix.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for initial testing, following the directions of Maron and Ames (Mutation Res. 113, 1983, 173-215); independent repeat as preincubation testing (preincubation for 20 min. at 37°C);
Testing for each strain and dose with and without S9 mix was performed in triplicate, which is also valid for solvent and positive controls.
DETERMINATION OF CYTOTOXICITY
- background growth
- mutant count: A toxic effect was assumed when there was a marked and dose-dependent reduction in the mutant count per plate, compared to the negative controls. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100, TA 1537and TA 98 this increase should be about twice that of negative/solvent controls. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgment.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None of the five strains used showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9 mix.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was indicated at the highest dose evaluated (5000 µg/plate)
ADDITIONAL INFORMATION ON CYTOTOXICITY: Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Three replicates per dose and tester strain with and without metabolic activation (n = 3)
1st experiment plate incorporation test (without metabolic activation)
Summary of mean values without S9 mix in the plate incorporation test | |||||
Strain | |||||
Dose µg/plate | TA1535 | TA100 | TA1537 | TA98 | TA102 |
0 | 9 ± 1 | 95 ± 10 | 8 ± 2 | 22 ± 2 | 270 ± 11 |
50 | 10 ± 1 | 93 ± 14 | 8 ± 3 | 18 ± 3 | 249 ± 20 |
158 | 8 ± 1 | 105 ± 7 | 8 ± 1 | 21 ± 3 | 240 ± 33 |
500 | 7 ± 1 | 83 ± 7 | 7 ± 1 | 21 ± 3 | 236 ± 12 |
1581 | 9 ± 2 | 92 ± 22 | 8 ± 1 | 21 ± 2 | 247 ± 17 |
5000 | 9 ± 2 | 98 ± 22 | 8 ± 1 | 23 ± 1 | 249 ± 8 |
Na-azide | 710 ± 45 | ||||
NF | 311 ± 16 | ||||
4 -NPDA | 34 ± 1 | 78 ± 4 | |||
MMC | 692 ± 34 |
1st experiment plate incorporation test (with metabolic activation)
Summary of mean values with S9 mix in the plate incorporation test | |||||
Strain | |||||
Dose µg/plate | TA1535 | TA100 | TA1537 | TA98 | TA102 |
0 | 11 ± 2 | 131 ± | 10 ± 3 | 36 ± 3 | 363 ± 8 |
50 | 11 ± 4 | 129 ± | 10 ± 2 | 31 ± 10 | 373 ± 8 |
158 | 12 ± 2 | 133 ± | 10 ± 2 | 30 ± 5 | 375 ± 17 |
500 | 10 ± 3 | 128 ± | 9 ± 3 | 29 ± 6 | 384 ± 35 |
1581 | 10 ± 2 | 115 ± | 10 ± 2 | 29 ± 5 | 374 ± 6 |
5000 | 10 ± 1 | 109 ± | 9 ± 1 | 31 ± 4 | 396 ± 28 |
2 -AA | 135 ± 2 | 2404 ± | 216 ± 31 | 2131 ± 393 | 830 ± 97 |
2nd experiment pre-incubation method (without metabolic activation)
Summary of mean values without S9 mix in the pre-incubation method | |||||
Strain | |||||
Dose µg/plate | TA1535 | TA100 | TA1537 | TA98 | TA102 |
0 | 8 ± 1 | 131 ± 6 | 7 ± 1 | 20 ± 4 | 251 ± 11 |
50 | 9 ± 2 | 115 ± 29 | 7 ± 1 | 22 ± 3 | 252 ± 7 |
158 | 9 ± 2 | 127 ± 29 | 8 ± 2 | 17 ± 4 | 235 ± 31 |
500 | 9 ± 2 | 124 ± 8 | 8 ± 2 | 16 ± 1 | 249 ± 32 |
1581 | 8 ± 2 | 130 ± 17 | 6 ± 1 | 15 ± 3 | 245 ± 14 |
5000 | 9 ± 3 | 129 ± 19 | 8 ± 2 | 20 ± 3 | 262 ± 27 |
Na-azide | 872 ± 31 | ||||
NF | 463 ± 49 | ||||
4 -NPDA | 37 ± 4 | 71 ± 2 | |||
Cumene | 508 ± 16 |
2nd experiment pre-incubation method (with metabolic activation)
Summary of mean values with S9 mix in the pre-incubation method | |||||
Strain | |||||
Dose µg/plate | TA1535 | TA100 | TA1537 | TA98 | TA102 |
0 | 12 ± 3 | 216 ± 11 | 10 ± 1 | 32 ± 5 | 318 ± 12 |
50 | 13 ± 3 | 205 ± 21 | 9 ± 2 | 30 ± 5 | 298 ± 44 |
158 | 10 ± 2 | 187 ± 15 | 10 ± 1 | 31 ± 3 | 293 ± 25 |
500 | 10 ± 1 | 190 ± 15 | 8 ± 1 | 26 ± 4 | 324 ± 37 |
1581 | 10 ± 3 | 167 ± 2 | 10 ± 2 | 28 ± 3 | 334 ± 32 |
5000 | 11 ± 1 | 185 ± 8 | 9 ± 1 | 26 ± 4 | 318 ± 36 |
2-AA | 113 ± 8 | 1870 ± 139 | 288 ± 23 | 1633 ± 223 | 521 ± 13 |
Applicant's summary and conclusion
- Executive summary:
Mecoprop-P n-octyl ester was investigated in a bacterial reverse mutation (Ames) test according to OECD TG 471 on Salmonella typhimurium TA 1535, TA 100, TA, 1537, TA 98, and TA 102. Cytotoxicity was not indicated up to 5000 µg/plate. Precipitation of the test substance was noted at 5000 µg/plate.
None of the five strains showed a dose-related and biologically relevant increase in mutant counts over those of the negative controls in the initially performed plate incorporation as well as in the independently performed preincubation modification, each conducted with and without S9 mix.
Therefore, Mecoprop-P n-octyl ester was considered to be non-mutagenic.
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.
