Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 907-237-7 | 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
- 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:
- 02-12-2016 to 19-01-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of undec-8-enal and undec-9-enal and undec-10-enal
- EC Number:
- 907-237-7
- Molecular formula:
- C11H20O
- IUPAC Name:
- Reaction mass of undec-8-enal and undec-9-enal and undec-10-enal
Constituent 1
Method
- Target gene:
- Histidine and tryptophan genes
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
- Test concentrations with justification for top dose:
- Experiment 1 (plate incorporation method)
Without S9: Initial: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate ; Amended: TA100, TA1535 and TA1537 (without S9): 0.015, 0.05, 0.15, 0.5, 1.5, 5, 15, 50, 150 μg/plate.
With S9: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate for TA100, TA98, TA1537 and E.coli. For TA1535: 0.15, 0.5, 1.5, 5, 15, 50, 150, 500 μg/plate.
Results from the first mutation test showed significant toxicity of the test item to the bacterial tester strains and consequently an insufficient number of non-toxic dose levels.
Experiment 2 (pre-incubation method)
Without S9: 0.05, 0.15, 0.5, 1.5, 5, 15, 50, 150 μg/plate (based on results of experiment 1).
With S9: 0.05, 0.15, 0.5, 1.5, 5, 15, 50, 150 μg/plate (based on results of experiment 1). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: according to guidelines
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other:
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment 1: Plate incorporation methodology
Experiment 2: Pre-incubation methodology
DURATION
- Preincubation period: with and without S9-mix 20 minutes (prior to exposure in experiment 2 only)
- Exposure duration: 48 hours (experiment 1 and 2)
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn measurement and reduction in revertant colonies compared to the controls - Evaluation criteria:
- There are several criteria for determining a positive result. Any one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p < 0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98, TA100 and WP2 uvrA
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 150 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA1535, TA1537, TA98, TA100 and WP2uvrA
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 5 μg/plate (TA 1535), 15 μg/plate (TA 1537 & TA 100) and 50 μg/plate (TA98 and WP2uvrA).
- 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.
HISTORICAL CONTROL DATA:
-A history profile of vehicle, untreated and positive control values (reference items) can be found in the attached illustration.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
-In exp 1 (plate incorporation method): the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 50 μg/plate in the absence of S9-mix and 150 μg/plate in the presence of S9-mix. Consequently the toxic limit was employed as the maximum dose in the second mutation test.
-In exp 2 (pre-incubation method): The test item induced a stronger toxic response in the second mutation test (pre-incubation method), with weakened bacterial background lawns noted in the absence of S9-mix from 5 μg/plate (TA1535), 15 μg/plate (TA100 and TA1537) and 50 μg/plate (TA98 and WP2uvrA). In the presence of S9-mix, weakened bacterial background lawns were noted to all of the tester strains from 150 μg/plate.
ADDITIONAL INFORMATION ON TEST RESULTS
-In exp 1 (plate incorporation method): There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix).
-In exp 2 (pre-incubation method): no toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix). Statistically significant increases in TA1535 revertant colony frequency were observed in the second mutation test at 150 μg/plate in the presence of S9-mix. These increases were considered to have no biological relevance because weakened bacterial background lawns were also noted at the same dose level. Therefore these responses would be due to additional histidine being available to His- bacteria allowing these cells to undergo several additional cell divisions and presenting as non-revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Intreleven aldehyde was determined to be not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
The mutagenic activity of Intreleven aldehyde was evaluated in accordance with OECDG 471 and GLP principles. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to nine dose levels, in triplicate, both with and without the addition of S9-mix. Based on results of experiment 1 (plate incorporation), the dose range used for experiment 2 (pre-incubation method) was between 0.05 and 150 μg/plate. Cytotoxicity, as evidenced by a decrease in the number of revertants and background lawn, was observed. In the first mutation test (plate incorporation method), the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 50 μg/plate in the absence of S9-mix and 150 μg/plate in the presence of S9-mix. Consequently the toxic limit was employed as the maximum dose in the second mutation test. Weakened bacterial background lawns were noted in the absence of S9-mix from 5 μg/plate (TA1535), 15 μg/plate (TA100 and TA1537) and 50 μg/plate (TA98 and WP2uvrA) in the second experiment. In the presence of S9-mix, weakened bacterial background lawns were noted to all of the tester strains from 150 μg/plate. These increases were considered to have no biological relevance. No precipitation was observed at any of the concentrations. Adequate negative and positive controls were included. There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) for both experiments. Intreleven aldehyde was therefore considered to be non-mutagenic under the conditions of this test.
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.