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EC number: 228-985-4 | CAS number: 6386-38-5
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-guideline study, non-GLP study, no E.Coli WP2 or TA 102 was tested, with QAU statement, comparable to guideline, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no E.coli WP2 or Ta 102 strains were tested, no details on cytotoxicity, no historical data, overall limited details
- GLP compliance:
- no
- Remarks:
- QAU statement included
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 228-985-4
- EC Name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 6386-38-5
- Molecular formula:
- C18H28O3
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
- Details on test material:
- - Analytical purity: > 99%
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9 fraction of rat liver
- Test concentrations with justification for top dose:
- 20, 80, 320, 1280 and 5120 µg/0.1 ml in two independent experiments.
- Vehicle / solvent:
- - Vehicle used: acetone
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see "details on test system"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
The experiment was performed twice to confirm the results.
DURATION
- Exposure duration: 48h at 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- growth of background lawn
POSITIVE CONTROLS
- Without S9-mix
TA 98: daunorubicin-HCl, 5 and 10 µg/0.1 ml phosphate buffer;
TA 100: 4-nitroquinoline-N-oxide, 0.125 and 0.25 µg/0.1 ml phosphate buffer
TA 1535: N-methyl-N'-nitro-N-nitrosoguanidine, 3 and 5 µg/0.1 ml phosphate buffer
TA 1537: 9(5)aminoacridine hydrochloride monohydrate, 50 and 100 µg/0.1 ml DMSO
TA 1538: 2-nitrofluorene, 5 and 10 µg/0.1 ml DMSO.
- With S9-mix
TA 1535: cyclophosphamide, 250 µg/0.1 ml phosphate buffer. - 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:
- When the colonies had been counted, the arithmetic mean was calculated.
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Precipitation: At the concentration of 5120 ug/0.1 ml the substance precipitated in soft agar.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
NUMBER OF BACK-MUTANT COLONIES PER PLATE (ARITHMETIC MEAN)
EXPERIMENT 1
|
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | |||||
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Dose/0.1 ml | ||||||||||
Solvent Control | 19 | 38 | 185 | 173 | 10 | 15 | 5 | 14 | 13 | 26 |
20 µg | 21 | 45 | 178 | 157 | 12 | 12 | 6 | 13 | 8 | 23 |
80 µg | 18 | 40 | 188 | 171 | 15 | 14 | 9 | 13 | 9 | 22 |
320 µg | 21 | 42 | 156 | 175 | 12 | 12 | 9 | 13 | 9 | 26 |
1280 µg | 20 | 34 | 192 | 167 | 8 | 15 | 5 | 15 | 7 | 24 |
5120 µg | 22 | 38 | 160 | 151 | 13 | 9 | 4 | 16 | 11 | 15 |
Positive Controls* | ||||||||||
Solvent Control | 26 | - | 179 | - | 8 | 11 | 7 | - | 14 | - |
Concentration A | 534 | - | 657 | - | 395 | 455 | 103 | - | 731 | - |
Concentration B | 880 | - | 1063 | - | 1394 | - | 724 | - | 968 | - |
EXPERIMENT 2
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | ||||||
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
Dose/0.1 ml | ||||||||||
Control | 23 | 42 | 155 | 158 | 13 | 11 | 6 | 9 | 12 | 28 |
20 µg | 18 | 41 | 158 | 138 | 10 | 12 | 9 | 12 | 14 | 21 |
80 µg | 22 | 41 | 135 | 124 | 9 | 11 | 5 | 12 | 11 | 24 |
320 µg | 26 | 46 | 150 | 148 | 11 | 12 | 7 | 13 | 10 | 18 |
1280 µg | 22 | 37 | 147 | 143 | 10 | 14 | 6 | 15 | 12 | 23 |
5120 µg | 17 | 29 | 128 | 123 | 11 | 10 | 6 | 11 | 10 | 24 |
Positive Controls* | ||||||||||
Control | 15 | - | 128 | - | 12 | 10 | 9 | - | 13 | - |
Concentration A | 377 | - | 627 | - | 112 | 525 | 45 | - | 888 | - |
Concentration B | 605 | - | 989 | - | 772 | - | 219 | - | 1662 | - |
* Details on positive controls including concentrations see "Details on test system and conditions"
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
No increase of the number of histidine-prototrophic mutants after treatment with the test substance either with or without metabolic activation was observed, therefore, the test article is considered to be not mutagenic. - Executive summary:
The test substance was tested for mutagenic effects on histidine-auxotrophic mutants of Salmonella typhimurium. The investigations were performed on strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 with the following concentrations of the trial substance without and with microsomal activation: 20, 80, 320, 1280 and 5120 µg/0.1 ml. In order to confirm the results, the experiments were repeated. 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 the test article revealed no marked deviations. No evidence of the induction of point mutations by the test substance or by the metabolites of the substance formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments.
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