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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 309-629-8 | CAS number: 100545-48-0
- 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:
- From 29 August 2012 to 17 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- EC Number:
- 309-629-8
- EC Name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- Cas Number:
- 100545-48-0
- Molecular formula:
- No discrete molecular formula available for this UVCB substance
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
Method
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:
- S9 fraction, from male Sprague-Dawley rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Plate incorporation assay: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (with and without metabolic activation)
Pre-incubation assay: 50, 150, 500, 1500 and 5000 µg/plate (with and without metabolic activation)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- Sodium azide: (2 µg/plate for strains TA100 and TA1535), 9-aminoacridine: (50 µg/plate for strain TA1537), 2-nitrofluorene: (2 µg/plate for strain TA98) and 4-nitroquinoline-1-oxide: (2 µg/plate for strain WP2 uvrA (pKM101)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- 2-Aminoanthracene: 5 µg/plate for strains TA100 and TA1535 and 10 µg/plate for strain WP2 uvrA (pKM101); Benzo[a]pyrene: 5 µg/plate for strains TA98 and TA1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Plate incorporation method: (Test 1)
- Aliquots of 0.1 mL of the test substance solutions (at 5, 15, 50, 150, 500, 1500 and 5000 µg/plate), positive control or vehicle control (water + 0.15% agar) were placed in glass tubes. S9 mix (0.5 mL) or 0.1 M pH 7.4 phosphate buffer (0.5 mL) was added, followed by 0.1 mL of a 10 h bacterial culture and 2 mL of agar containing histidine (0.05 mM), biotin (0.05 mM) and tryptophan (0.05 mM). The mixture was thoroughly shaken and overlaid onto previously prepared Petri dishes containing 25 mL minimal agar. Each Petri dish was individually labeled with a unique code, identifying the contents of the dish. Triplicates were used for each treatment.
- Plates were also prepared without the addition of bacteria in order to assess the sterility of the test substance, S9 mix and sodium phosphate buffer. All plates were incubated at approximately 37°C for ca 72 h. After the incubation period, the appearance of the background bacterial lawn was examined and revertant colonies were counted using an automated colony counter. Any toxic effects of the test substance were detected by a substantial reduction in mean revertant colony counts or by a sparse or absent background bacterial lawn. In the absence of any toxic effects, the maximum concentration was selected for use in the second test. If toxic effects were observed, a lower concentration would be chosen, ensuring that signs of bacterial inhibition are present at this maximum concentration. Ideally, a minimum of four non-toxic concentrations should be obtained. If precipitate is observed on the plates at the end of the incubation period, at least one precipitating concentration should be included in the second test.
Preincubation method: (Test 2)
As a clear negative response was obtained in the first test, a variation to the test procedure was used for the second test. The variation used was the pre-incubation assay in which the tubes, which contained mixtures of bacteria, buffer or S9 mix and test dilution, were incubated at 37°C for 30 minutes with shaking before the addition of the agar overlay. The maximum concentration chosen was again 5000 µg/plate, but only five concentrations were used. - Evaluation criteria:
- - Test substance is considered to have mutagenic activity: If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive concentration-response relationship, it is considered to exhibit mutagenic activity in this test system.
- Test substance is not considered to have mutagenic activity: If exposure to a test substance does not produce a reproducible increase in revertant colony numbers, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
- If the results obtained fail to satisfy the criteria for a clear “positive” or “negative” response, even after additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers.
- Test is considered valid: If the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the current historical control range for the laboratory unless otherwise justified by the Study Director. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537, which have relatively low spontaneous reversion rates) that of the concurrent vehicle controls. Mean viable cell counts in the 10-h bacterial cultures must be at least 10E09/mL. - Statistics:
- The statistical procedures used were usually Dunnett’s test followed, if appropriate, by trend analysis. Biological importance was considered along with statistical significance.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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
- Additional information on results:
- Test 1:
- No evidence of toxicity was obtained following exposure to the test substance. A maximum exposure concentration of 5000 µg/plate was, therefore, selected for use in the second test.
- No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to test substance at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
Test 2:
- No evidence of toxicity was obtained following exposure to the test substance.
- No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to test substance at any concentration up to and including 5000 µg/plate in either the presence or absence of S9 mix.
Any other information on results incl. tables
- The results in detail obtained with the test substance and positive control compounds are presented in appendix 2 of the attached background material.
- The absence of colonies on sterility check plates confirmed the absence of microbial contamination of the S9 mix, buffer and test substance formulation.
- The viability counts confirmed that the viable cell density of the cultures of the individual organisms exceeded 109/mL in all cases, and therefore met the acceptance criteria.
- The mean revertant colony counts for the vehicle controls were within or close to the current historical control range for the laboratory.
- Appropriate positive control chemicals (with S9 mix where required) induced substantial increases in revertant colony numbers with all strains in all reported tests, confirming sensitivity of the cultures and activity of the S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance showed no evidence of mutagenic activity in the bacterial system.
- Executive summary:
An in vitro Ames assay was conducted to determine the mutagenic potential of the test substance according to OECD Guideline 471, EU Method B.13/14 and EPA OPPTS 870.5100 in compliance with GLP.
Tester strains TA98, TA100, TA1535 and TA1537 of Salmonella typhimurium and strain WP2uvrA of Escherichia coli were evaluated in the presence and absence of metabolic activation. The test was performed in two independent assays using the plate incorporation and the pre-incubation methods. Water containing 0.15% bacteriological agar was selected as the vehicle of choice. In the first test, the dose levels were: 5, 15, 50, 150, 500, 1,500 and 5,000 µg/plate (with and without metabolic activation). In the second test, the dose levels were 50, 150, 500, 1,500 and 5,000 µg/plate (with and without metabolic activation). No positive mutagenic responses were observed with any of the strains in the absence and presence of S9 mix. Neither any precipitate nor appreciable toxicity was seen.
Under the study conditions, the test substance therefore showed no evidence of mutagenic activity in the bacterial system.
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.