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EC number: 264-165-2 | CAS number: 63449-95-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 August 2016 - 22 September 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(isopropyl)cyclohexyl propionate
- EC Number:
- 264-165-2
- EC Name:
- 4-(isopropyl)cyclohexyl propionate
- Cas Number:
- 63449-95-6
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 4-(isopropyl)cyclohexyl propionate
- Test material form:
- other: liquid
- Details on test material:
- - Storage condition of test material: Store in cool dark place at room temperature
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- Escherichia coli: Tryptophan gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
TA 1535, TA 1537 and TA 98 (without and with S9): 17, 52, 164, 512, 1600 and 5000 μg/plate
Pre-incubation:
- Dose range finding test:
TA 100 and WP2uvrA (without and with S9): 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate
- Experiment 2:
TA 1535, TA 1537 and TA98 (without S9): 0.17, 0.55, 1.7, 5.4, 17 and 52 μg/plate
TA 1535, TA 1537 and TA98 (with S9): 1.7, 5.4, 17, 52, 164 and 512 μg/plate
TA 100 (without S9): 0.17, 0.55, 1.7, 5.4, 17 and 52 μg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: A solubility test was performed. The test item was dissolved in dimethyl sulfoxide.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100 μL/plate DMSO
- 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 item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 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. - Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Direct plate: without S9 at concentrations of 164 μg/plate and upwards and with S9 no toxicity was observed. Pre-incubation: without S9-mix at concentrations of 52 μg/plate and upwards and with S9 at concentrations of 164 μg/plate and upwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Direct plate: without S9 at concentrations of 164 μg/plate and upwards and with S9 no toxicity was observed. Pre-incubation: without S9-mix at concentrations of 17 μg/plate and upwards and with S9 at the concentration of 512 μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Direct plate: without S9 at conc. of 164 μg/plate and upwards and with S9 at conc. of 1600 μg/plate and upwards. Pre-incubation: without S9-mix at conc. of 17 μg/plate and upwards and with S9 at conc. of 164 μg/plate and upwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Direct plate: without S9 at conc. of 164 μg/plate and upwards and with S9 at the conc. of 5000 μg/plate and upwards. Pre-incubation: without S9-mix at conc. of 17 μg/plate and upwards and with S9 at the conc. of 512 μg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Direct plate: no toxicity was observed. Pre-incubation: no toxicity was observed without S9-mix and with S9 toxicity was observed at conc. of 1600 μg/plate and upwards.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Direct plate: The test item precipitated at the concentrations of 1600 and/or 5000 μg/plate in the absence and presence of S9-mix in the strains TA1535, TA1537 and TA98. The test item did not precipitate in strain TA 100 and WP2uvrA.
Pre-incubation: The test item precipitated on the plates at dose levels of 1600 and 5000 μg/plate in the absence of S9-mix and at 5000 μg/plate in the presence of S9-mix in strains TA 100 and WP2uvrA. In the tester strains TA1535, TA1537 and TA98 no precipitate was observed up to the highest dose level tested.
RANGE-FINDING/SCREENING STUDIES:
Direct plate: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in TA100 without S9 at concentrations of 164 μg/plate and upwards and with S9 no toxicity was observed. In addition, no toxicity was observed at any of the dose levels tested in strain WP2uvrA.
Pre-incubation: Toxicity was observed in TA100 without S9-mix at concentrations of 52 μg/plate and upwards and with S9 at concentrations of 164 μg/plate and upwards. In strain WP2uvrA no toxicity was observed without S9-mix and with S9 toxicity was observed at conc. of 1600 μg/plate and upwards.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
TA1535 TA1537 TA98
S9-mix - + - + - +
Range 78 - 1381 78 - 1058 55 – 1565 55 – 1112 410 – 2057 263 - 1907
Mean 785 228 653 387 1155 860
SD 167 105 290 143 370 323
n 1684 1662 1448 1536 1646 1686
TA100 WP2uvrA
S9-mix - + - +
Range 549 – 1848 620 - 2651 127 – 1951 85 - 1390
Mean 892 1404 1263 342
SD 178 327 461 165
n 1650 1677 1370 1410
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between 31 May 2014 and 31 May 2016.
- Negative (solvent/vehicle) historical control data:
TA1535 TA1537 TA98 TA100 WP2uvrA
S9-mix - + - + - + - + - +
Range 4 - 36 3 - 34 3 – 25 3 - 28 9 - 50 9 - 57 63 - 153 60 - 156 12 – 68 12 - 70
Mean 14 13 7 9 17 25 100 103 26 32
SD 6 5 3 4 5 7 16 18 7 8
n 1662 1677 1548 1547 1662 1703 1659 1691 1421 1424
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between 31 May 2014 and 31 May 2016.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Direct plate: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all Salmonella typhimurium tester strains in the absence and presence of S9-mix, except in tester strain TA100 in the presence of S9-mix. In addition, no toxicity was observed at any of the dose levels tested in strain WP2uvrA.
- Pre-incubation: Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix, except in tester strain WP2uvrA in the absence of S9-mix.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed according to OECD 471 - Ames (1997) and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in the Ames test 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 in the absence and presence of S9-mix up to and including the precipitating concentration of 5000 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in TA 98, TA 1535, TA 1537 and TA 100 in the absence of S9 -mix tester strains in the absence and presence of S9-mix. In tester strain TA100 in the presence of S9-mix and in tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested.
In the second pre-incubation experiment, test item was initially tested in the dose range-finding study in TA 100 and WP2uvrA up to concentrations of 5000 μg/plate.
The test item was tested up to concentrations of 52 μg/plate in the tester strains TA1535, TA1537, TA98 and TA100 in the absence of S9-mix, and up to 512 μg/plate in the tester strains TA1535, TA1537 and TA98 in the presence of S9-mix in the pre-incubation assay. Cytotoxicity, as evidenced by a decrease in the number of revertants, reduction of the bacterial background lawn and/or the presence of microcolonies, was observed in all tester strains in the absence and presence of S9-mix.
Acceptable responses were obtained for the negative and strain-specific positive control items indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in any of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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