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EC number: 944-520-4 | 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
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- 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
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- 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
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- Nanomaterial radical formation potential
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: negative based on read across from Cedryl Acetate 'mono' and Longifolene Coeur both tested in an OECD TG 471.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across information.
- Justification for type of information:
- The read across justification is presented in the Endpoint summary Genotoxicity. The accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: read-across from Cedryl Acetate 'mono'
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay, based on the results of the source substance.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 August 2000 - 29 September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This information is used for read across to Cedryl Acetate EOA
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED- Source of cells: Dr. Bruce N. Ames, University of California, Berkeley, California, USAMEDIA USED- Type and identity of media including CO2 concentration if applicable:- Properly maintained: [yes/no]- Periodically checked for Mycoplasma contamination: [yes/no]- Periodically checked for karyotype stability: [yes/no)- Periodically 'cleansed' against high spontaneous background: [yes/no]
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix
- Test concentrations with justification for top dose:
- Experiment 1:
- TA98, TA100, TA102 & TA1537 (with and without S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
- TA1535 (without S9): 50, 150, 500, 1500 and 5000 µg/plate
- TA1535 (with S9): 15, 50, 150, 500 and 1500 µg/plate
Experiment 2:
- TA98 & TA100 (with and without S9): 50, 150, 500, 1500 and 5000 µg/plate
- TA102 (with and without S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
- TA1535 & TA1537 (without S9): 50, 150, 500, 1500 and 5000 µg/plate
- TA1535 & TA1537 (with S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment 3:
- TA102 (with S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
The dose levels were chosen based on the outcome of an initial (cyto)toxicity test. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: standard solvent - Untreated negative controls:
- yes
- Remarks:
- (untreated plates)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: Alleexperiments were performed in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: assessment of the reduction in the number of revertant colonies and diminution of the background lawn - Rationale for test conditions:
- Standard plate incorporation test conditions.
- Evaluation criteria:
- A significant increase in number of mutant colonies is considered a mutagenic response. A dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels supports this. An additional general rule is that two-fold (or more) increases in mean revertant numbers must be observed between the solvent control and a specific dose level.
- Statistics:
- An estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was made using a X2-test (Mohn and Ellenberger, 1977).
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test compound on the plates was observed at 1500 and 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES: Initial toxicity test was performed to determine dose levels.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The number of spontaneous revertants observed using each of the live strains was close to those previously established in the laboratory and was within the range obtained by Ames et al. (1975) as well as reported by De Serres and Shelby (1979).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Cytotoxicity was observed in the presence of S9-mix towards the strains TA1537 and TA102 at 5000 µg/plate and in the absence of S9-mix towards the strain TA102 at 5000 µg/plate. - Conclusions:
- Under the conditions of this study, the test substance was determined to be not mutagenic and does not need to be classified for mutagenicity in accordance with the criteria outline in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed according to the standard plate-incorporation assay, in the absence and presence of S9-mix. The dose levels were selected based on an initial toxicity test. Adequate negative and positive controls were included. A significant increase in the mutation frequency of the tester strain TA102 in the presence of a metabolic activation system was seen in one of three experiments. This was not observed in the absence of S9-mix. The substance did not induce a significant increase in the number of revertant colonies in any of the other S. typhimurium strains (TA1535, TA1537, TA98 and TA100), both in the absence and presence of S9-metabolic activation. The significant increase in mutation frequency for TA102 was only evident in 1 out of 3 tests which have been performed with a metabolizing system, not found to be dose-dependent and also not two-fold as compared to the solvent control. Also the mean mutant frequency at each of the dose levels was still within the historical control range for this strain. Based on this, the overall result for strain TA102 is considered negative, as well as for the other strains. Based on these results, the substance was found to be not mutagenic and does not need to be classified for mutagenicity in accordance with the criteria outline in Annex I of the CLP Regulation (1272/2008/EC).
- 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:
- 30 May 2001 - 18 June 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This information is used for read across to Cedryl Acetate EOA
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- 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:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone.
- Test concentrations with justification for top dose:
- - Dose range finding test (direct plate and pre-incubation):
TA 98 and TA 100 (without and with S9): 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Experiment 1:
TA 1535, TA 1537, TA 98, TA 100 and TA 102 (without and with S9): 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Experiment 2:
Due to toxicity in the pre-incubation dose range finding test the following dose levels were used:
TA 1535, TA 1537 and TA 102 (without and with S9): 3, 10, 33, 100, 333 and 1000 µg/plate
TA 98 and TA 100 (without and with S9): 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Solvent used: Ethanol
- Justification for choice of solvent: The test substance was dissolved in ethanol. The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (100 µL/plate ethanol)
- 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: preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain.
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 as positive if a biologically relevant and dose related increase in the number of revertants is induced.
A test item producing neither a dose related increase in the number of revertants nor a biologically relevant positive response at any one of the test points is considered non mutagenic in this system.
A biologically relevant response is described as follows:
A test item is considered mutagenic if in strains TA 98, TA 100, and TA 102 the number of reversions will be at least twice as high and in strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate.
Also, a dose-dependent and reproducible increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the highest dose will induce the above described enhancement factors or not. - Statistics:
- A statistical analysis of the data is not required.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
- Toxicity was observed in both TA 98 and TA 100 in the pre-incubation assay up to and including 5000 µg/plate, both in the absence and presence of S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with 59 mix and in strain TA 100 with and without 59 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without 59 mix.
Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation. - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent experiments, the first in agar (plate incorporation) and the second a pre-incubation experiment, both in the absence and presence of S9-mix up to and including 5000 μg/plate. Adequate negative and positive controls were included.
In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with S9 mix and in strain TA 100 with and without S9 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without S9 mix. Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation.
The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), 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 the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity is assessed based on read-across from Cedryl Acetate 'mono' and Longifolene Coeur to Cedryl Acetate EOA. The executive summary of the source information is presented below followed by the read-across rationale.
Cedryl Acetate 'mono' Ames
The mutagenic activity of Cedryl Acetate 'mono' was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed according to the standard plate-incorporation assay, in the absence and presence of S9-mix. The dose levels were selected based on an initial toxicity test. Adequate negative and positive controls were included. A significant increase in the mutation frequency of the tester strain TA102 in the presence of a metabolic activation system was seen in one of three experiments. This was not observed in the absence of S9-mix. The substance did not induce a significant increase in the number of revertant colonies in any of the other S. typhimurium strains (TA1535, TA1537, TA98 and TA100), both in the absence and presence of S9-metabolic activation. The significant increase in mutation frequency for TA102 was only evident in 1 out of 3 tests which have been performed with a metabolizing system, not found to be dose-dependent and also not two-fold as compared to the solvent control. Also the mean mutant frequency at each of the dose levels was still within the historical control range for this strain. Based on this, the overall result for strain TA102 is considered negative, as well as for the other strains.
Longifolene Coeur Ames
The mutagenic activity of Longifolene Coeur was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent experiments, the first in agar (plate incorporation) and the second a pre-incubation experiment, both in the absence and presence of S9-mix up to and including 5000 μg/plate. Adequate negative and positive controls were included. In experiment I, toxic effects, evident as a reduction in the number of revertants, were observed in strain TA 1537 with S9 mix and in strain TA 100 with and without S9 mix. In experiment II, toxic effects were observed in strains TA 1535, 1537, 98, and 100 with and without S9 mix. Irregular background growth was observed in strains TA 1537 and TA 98 in the second experiment at 333 µg/plate and above with metabolic activation and at 1000 µg/plate and above in strain TA 100 without metabolic activation. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), 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 the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
The genetic toxicity (AMES study) of Cedryl Acetate EOA based on read across from data available for Cedryl Acetate (mono) (CAS #77-54-3) and Longifolene Coeur (CAS #475-20-7)
Introduction and hypothesis for the analogue approach
Cedryl acetate EOA consists of one major, two minor constituents and a number of impurities, all containing a hydrocarbon fused-ring system.Half of the constituents have an acetate attached to this ring the other half does not have this ester group. Most constituents have a double bond with a methyl group attached.The constituents are sub-grouped into two main types: Cedryl acetate-type and Longifolene Coeur (hydrocarbon-fused-ring-type).
For Cedryl Acetate EOA there are no in vitro mutagenicity data available.In accordance with Article 13 of REACH, lacking information can be generated by means other than experimental testing, i.e. applying alternative methods such as QSARs, grouping and read-across.For assessing the in vitromutagenicity in bacteria of Cedryl Acetate EOA, the analogue approach is selected because for one of its constituents, Cedryl Acetate ‘mono’ Ames data are available. For the hydrocarbon-fused-ring-type Longifolene Coeur is a representative for which also Ames data are available.
Hypothesis:Cedryl acetate EOA has the same mutagenicity as Cedryl Acetate ‘mono’ and as Longifolene Coeur.
Available information:For Cedryl Acetate ‘mono’ and for Longifolene Coeur negative results from Ames tests are available (OECDTG 471, Rel. 1).
Target chemical and source chemical(s)
Chemical structures of the target chemical and the source chemical(s) are shown in the data matrix, including physico-chemical properties and available toxicologicalinformation.
Purity / Impurities
The unidentified impurities of Cedryl Acetate EOA are not considered to have a significant influence on the mutagenic potential.
Analogue approach justification
According to Annex XI 1.5 read across can be used to replace testing when the similarity can be based on a common backbone and a common functional group. When using read across the result derived should be applicable for C&L and/or risk assessment and it should be presented with adequate and reliable documentation, which is presented below.
Analogue selection:Cedryl Acetate ‘mono’ was selected as an analogue because Cedryl Acetate ‘mono’ is a key constituent of Cedryl acetate EOA and can represent the other acetates in Cedryl Acetate EOA. In addition, Longifolene Coeur was selected as an analogue because this source substance presents the hydrocarbon-type in Cedryl Acetate EOA.
Structural similarities and differences: The source and Cedryl Acetate EOA components all have a hydrocarbon fused-ring system with or without an acetate-group. Cedryl acetate ‘mono’ represents the subgroup of Cedryl Acetate EOA with the acetate group. Longifolene Coeur represents the one with a hydrocarbon backbone with a double bond. A number of constituents have a double bond which also can be methylated. These functional groups are prone to oxidation.
Toxico-kinetic, Absorption: Cedryl Acetate EOA will be similar absorbed compared to both source chemicals (Cedryl Acetate ‘mono’ and Longifolene Coeur) based on the similarities in chemical structure and physico-chemical properties. All constituents have high (estimated) log Kow values ( >5).Metabolism: The constituents of Cedral Acetate EOA with the acetate group will be cleaved e.g. carboxyl esterases (Toxicological handbooks) which will follow the same pattern as Cedryl Acetate ‘mono’. The (methylated) double bonds in other constituents of Cedral Acetate EOA will be prone for oxidation and give the corresponding alcohols. This is similar to the metabolic pathway of Longifolene Coeur.
Uncertainty of the prediction: There are no other uncertainties based on the reasoning above.
Data matrix
The relevant information on physico-chemical properties and toxicological characteristics are presented in the data matrix below.
Conclusions per endpoint for mutagenicity
For Cedryl Acetate EOA no mutagenicity information is available. Read across information is used to fill this data gap. When using read across the result derived should be applicable for C&L and/or risk assessment, with adequate and reliable documentation. This documentation is presented in the current text. For the two analogues Cedryl Acetate ‘mono’ and LongifoleneCoeurAmes information (Reliability 1) is available with negative results (not mutagenic). Based on these data, Cedryl acetate EOA is concluded to be not mutagenic.
Final conclusion: The Cedryl Acetate EOA is not mutagenic in the Ames test.
Data matrix for the read across to Cedryl Acetate EOSfrom Cedryl Acetate ‘mono’ and Longifolene Coeur for Ames information
Common names |
Cedryl Acetate EOA |
|
|
|
|
|
|
Cedryl acetate |
Longifolene Coeur |
|
Target |
Target |
Target |
Target |
Target |
Target |
Target |
Source |
Supporting source |
|
Cedryl Acetate type |
|
|
Longifolene type |
|
|
|
|
|
Chemical structures |
|||||||||
Typical concentration (%) |
30-45 (major) |
<10 |
<10 |
15-30 (minor)
|
8-16 (minor)
|
<10 |
<10 |
|
|
CAS no |
|
|
|
32435-95-3 |
22567-43-7 |
|
|
77-54-3 |
475-20-7 |
Einecs |
944-520-4 |
|
|
|
|
|
|
201-036-1 |
207-491-2 |
REACH |
|
2018 |
|
|
|
|
|
2018 |
2018 |
Molecular weight |
264 |
264 |
264 |
204 |
204 |
204 |
202 |
264 |
204 |
Phys-Chem data* |
|
|
|
|
|
|
|
|
|
Log Kow |
5.33 |
5.33 |
5.94 |
6.12 |
5.74 |
5.82 |
6.19 |
5.33 (6 exp.) |
5.48 (5 exp.) |
Human health |
|
|
|
|
|
|
|
|
|
Genotoxicity Ames test information |
Negative (Read across) |
Negative (Read across) |
Negative (Read across) |
Negative (Read across) |
Negative (Read across) |
Negative (RA) |
Negative (RA) |
Negative (OECDTG 471) |
Negative (OECD TG 471) |
*Physico-chemical properties are calculated with EpiSuite; RA=Read across
Justification for classification or non-classification
Based on the results, the substance does not need to be classified for genetic toxicity according to EU CLP (EC No. 1272/2008 and its amendments).
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.