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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 257-446-6 | CAS number: 51818-55-4
- 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:
- Bacterial Reverse Mutation Assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Start Date: 31 August 2017 Experimental Completion Date: 17 September 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guideline 471 (OECD, 1997).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Neodecanoic acid, iron salt
- EC Number:
- 257-446-6
- EC Name:
- Neodecanoic acid, iron salt
- Cas Number:
- 51818-55-4
- Molecular formula:
- C10H20O2.xFe
- IUPAC Name:
- λ²-iron(2+) bis(2-ethyl-2,5-dimethylhexanoate)
- Test material form:
- solid
- Details on test material:
- CAS Number: 51818-55-4
EC Number 257-446-6
Molecular formula: C30H57FeO6
Molecular weight: 569.6
Purity: 100%
Storage conditions: Refrigerated under Nitrogen ( 2-8 °C )
Constituent 1
- Specific details on test material used for the study:
- Batch number: E01133-065
Purity: 100%
Date received: 19 July 2017
Retest date: 31 July 2019
Storage conditions: 15-25°C, protected from light
Method
- Target gene:
- The test item was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation using an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- Mutation Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of the test item at 5, 16, 50, 160, 500, 1600 and 5000 µg/plate, plus vehicle and positive controls. Following these treatments, no evidence of toxicity was observed except in strain TA1537 at a concentration of 5000 µg/plate in the absence of S-9.
Mutation Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 160-5000 µg/plate, in order to examine more closely those concentrations of the test item approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments, no evidence of toxicity was observed. - Vehicle / solvent:
- All the test item treatments in this study were performed using formulations prepared in dimethylformamide (DMF).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene (2NF), Sodium azide (NaN3), 9-aminoacridine (AAC), Mitomycin C (MMC), Benzo[a]pyrene (B[a]P), 2-aminoanthracene (AAN)
- Details on test system and experimental conditions:
- The test item was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation using an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments.
- Rationale for test conditions:
- OECD guidline
- Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
1. A concentration related increase in revertant numbers was =1.5-fold (in strain TA102), =2-fold (in strains TA98 or TA100) or =3-fold (in strains TA1535 or TA1537) the concurrent vehicle control values
2. The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if both of the above criteria were met.
The test article was considered negative in this assay if neither of the above criteria were met.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA98, TA100, TA1535, TA1537 and TA102 of Salmonella typhimurium
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: It was concluded that the test item did not induce mutation
Any other information on results incl. tables
Details of all treatment solution concentrations and final test item concentrations are provided in the Test Article.
Mutation Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of the test item at 5, 16, 50, 160, 500, 1600 and 5000 µg/plate, plus vehicle and positive controls. Following these treatments, no evidence of toxicity was observed, except for a marked reduction in revertant numbers noted in strain TA1537 at a concentration of 5000µg/plate.
Mutation Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 160-5000 µg/plate, in order to examine more closely those concentrations of the test item approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments no evidence of toxicity was observed.
In Mutation Experiment 1, precipitation of the test article was observed on the test plates at concentrations of 5000 µg/plate in all strains in the absence and presence of S-9.
In Mutation Experiment 2, precipitation of the test article was observed on the test plates at concentrations of 2500 µg/plate and above in all strains in the absence of S-9 and at 1250 µg/plate and above in all strains in the presence of S-9.
The individual mutagenicity plate counts were averaged to give mean values.From the data it can be seen that vehicle control counts fell within the laboratory’s historical ranges.The positive control chemicals all induced increases in revertant numbers of=1.5-fold (in strain TA102), =2-fold (in strains TA98 and TA100) or =3-fold (in strains TA1535 and TA1537) the concurrent vehicle controlsconfirming discrimination between different strains, and an active S-9 preparation. The study therefore demonstrated correct strain and assay functioning and was accepted as valid.
Following the test item treatments of all the test strains in the absence and presence of S-9, no increases in revertant numbers were observed that were =1.5-fold (in strain TA102), =2-fold (in strains TA98 and TA100) or =3-fold (in strains TA1535 and TA1537) the concurrent vehicle control. This study was considered therefore to have provided no evidence of any test item mutagenic activity in this assay system.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the test item did not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 µg/plate (the maximum recommended concentration according to current regulatory guidelines), in the absence and in the presence of a rat liver metabolic activation system (S-9).
- Executive summary:
The test item was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium, both in the absence and in the presence of metabolic activation using an Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9), in two separate experiments.
All test item treatments in this study were performed using formulations prepared in dimethylformamide (DMF).
Mutation Experiment 1 treatments of all the tester strains were performed in the absence and in the presence of S-9, using final concentrations of the test item at 5, 16, 50, 160, 500, 1600 and 5000 µg/plate, plus vehicle and positive controls. Following these treatments, no evidence of toxicity was observed except in strain TA1537 at a concentration of 5000µg/plate in the absence of S-9.
Mutation Experiment 2 treatments of all the tester strains were performed in the absence and in the presence of S-9. The maximum test concentration of 5000 µg/plate was retained for all strains. Narrowed concentration intervals were employed covering the range 160-5000 µg/plate, in order to examine more closely those concentrations of the test item approaching the maximum test concentration and considered therefore most likely to provide evidence of any mutagenic activity. In addition, all treatments in the presence of S-9 were further modified by the inclusion of a pre-incubation step. In this way, it was hoped to increase the range of mutagenic chemicals that could be detected using this assay system. Following these treatments, no evidence of toxicity was observed.
In Mutation Experiment 1, precipitation was observed on the test plates at concentrations of 5000 µg/plate in all strains in the absence and presence of S-9.
In Mutation Experiment 2, precipitation was observed on the test plates at concentrations of 2500 µg/plate and above in all strains in the absence of S-9 and at 1250 µg/plate and above in all strains in the presence of S-9.
Vehicle and positive control treatments were included for all strains in both experiments. The mean numbers of revertant colonies fell withinacceptable ranges for vehicle control treatments, and were within historical control range of the positive control treatments.
It was concluded that the test item did not induce mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of Salmonella typhimurium when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 µg/plate (the maximum recommended concentration according to current regulatory guidelines),in the absence and in the presence of a rat
liver metabolic activation system (S-9).
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.