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EC number: 275-174-6 | CAS number: 71077-31-1
- 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:
- 19 March, 2015 - 16 April, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliability 1 is assigned because the study is conducted according to OECD TG 471, in compliance with GLP, without deviations that influence the quality of the results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,8-dimethyl-4,9-decadienal
- EC Number:
- 275-174-6
- EC Name:
- 4,8-dimethyl-4,9-decadienal
- Cas Number:
- 71077-31-1
- Molecular formula:
- C12H20O
- IUPAC Name:
- 4,8-dimethyl-4,9-decadienal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material in report: Floral Super
- Description: Clear liquid
- Storage condition of test material: At room temperature flushed with nitrogen
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- Escherichia coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by Aroclor 1254.
- Test concentrations with justification for top dose:
- Direct plate:
- Dose range finding test:
TA 100 and WP2uvrA (without and with S9): 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
- Experiment 1:
Due to cytotoxicity (in TA 100), the following dose levels were used:
TA 1535, TA 1537 and TA 98 (without S9): 0.54, 1.7, 5.4, 17, 52 and 164 μg/plate
TA 1535, TA 1537 and Ta 98 (with S9): 1.7, 5.4, 17, 52, 164 and 512 μg/plate
Preincubation:
- Dose range finding test:
TA 100 (without S9): 0.17, 0.54, 1.7, 5.4, 17, 52 and 164 µg/plate
TA 100 (with S9): 0.54, 1.7, 5.4, 17, 52, 164 and 512 µg/plate
WP2uvrA (without and with S9): 5.4, 17, 52, 164, 512, 1600 and 5000 µg/plate
- Experiment 1:
Due to cytotoxicity (in TA 100), the following dose levels were used:
TA 1535, TA 1537, TA 98 and TA 100 (without S9): 0.056, 0.18, 0.55, 1.7, 5.4, 17 and 52 μg/plate
TA 1535, TA 1537 and TA 98 (with S9): 0.55, 1.7, 5.4, 17, 52 and 164 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was found to be soluble in DMSO up to 5000 µg/plate
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (100 µL/plate)
- Positive controls:
- yes
- Positive control substance:
- other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1: in agar (plate incorporation)
- Experiment 2: (independent repeat): preincubation
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain (in all experiments)
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation - Evaluation criteria:
- A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity was observed in all tester strains.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Only in the preincubation assay without S9-mix at the concentration of 164 µg/plate and upwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the direct plate assay precipitation (oily droplets) was observed at the concentration of 1600 and 5000 µg/plate. In the preincubation assay, precipitation was observed at concentrations of 512 μg/plate in tester strain TA100 and at 5000 μg/plate in tester strain WP2uvrA.
RANGE-FINDING/SCREENING STUDIES:
- Direct plate assay: In strain TA 100 toxicity (microcolonies) was observed at the concentration of 164 µg/plate and above, both in the absence and presence of S9. In tester strain WP2uvrA, no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
- Preincubation assay: In strain TA 100 toxicity was observed at the concentration of 164 µg/plate and above, in the presence of S9. In the absence of S9, toxicity was observed at concentration of 17 and 52 µg/plate. In tester strain WP2uvrA, toxicity was observed at the concentration of 164 µg/plate and above, in the absence of S9. In the presence of S9, no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Direct plate assay: In all strains toxicity (microcolonies) was observed at the higher doses (at >= 164 µg/plate), both in the absence and/or presence of S9.
- Preincubation assay: In all strains toxicity (microcolonies) was observed at the concentrations of 17 and 52 µg/plate, in the absence of S9. In the presence of S9, in all strains toxicity was observed at the concentration of 164 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Floral Super is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay performed according to OECD 471 (1997) and GLP principles. - Executive summary:
The mutagenic activity of Floral Super was evaluated in accordance with OECD 471 (1997) guideline and according to GLP principles. The test was performed in two independent experiments: at first a direct plate assay was performed and secondly a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in dose range finding tests in strain TA 100 (direct plate -/+ S9 and preincubation +S9 >= 164 µg/plate, preincubation -S9 17 and 52 µg/plate). Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and E. coli tester strain (WP2uvrA), both in the absence and presence of S9 -metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that Floral Super is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay.
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