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EC number: 800-362-7 | CAS number: 1307863-78-0
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 16 October 2003 - 5 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent adequately performed an dreported study according to standard guideline and in compliance to GLP.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Oleyl diamine, dioleate
- IUPAC Name:
- Oleyl diamine, dioleate
- Test material form:
- other: Fluid
- Details on test material:
- name: INIPOL 002
other name: N-alkyl "oleyl" propylene diamine dioleate
CAS number: 40027-38-1
batch number: 11638106
Sponsor's filing number: GRL 0023/03
description: viscous orange-colored liquid
container: one glass flask
date of receipt: 22 September 2003
storage conditions: at room temperature and protected from light
purity: 97.40%
composition: see analytical certificate
expiry date: September 2004.
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine gene
Species / strain
- 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:
- Aroclor 1254 induced rat liver microsomes
- Test concentrations with justification for top dose:
- Preliminary test: with and without S9: 10, 100, 500, 1000, 2500 and 5000 μg/plate.
Precipitate seen at ≥ 2500 μg/plate
Experiment 1 and 2: All tester strains in triplicate:
Range of dose levels up to toxicity involved:
3.91, 7.81, 15.6, 31.3, 62.5, 93.75, 125, 250, 375 and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:
Test compound was stable and soluble in ethanol and ethanol has been accepted and approved by authorities and international guidelines
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- in agar (plate incorporation) for preliminary test, both experiments without S9 mix and the first experiment with S9 mix
- preincubation method: Second experiment with S9-mix: 60 minutes at 37°C before plating
DURATION
- Exposure duration: 48 to 72 hours of incubation at 37°C,
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
DETERMINATION OF CYTOTOXICITY
- Method: Decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- Acceptance criteria:
. the number of revertants in the vehicle controls is consistent with the historical data of the testing facility,
. the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with the historical data of the testing facility.
Evaluation criteria
A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship.
Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY TOXICITY TEST
The test item was freely soluble in the vehicle (ethanol) at 100 mg/mL.
Consequently, with a treatment volume of 50 μL/plate, the dose-levels were 10, 100, 500, 1000, 2500 and 5000 μg/plate.
A marked precipitate was observed in the Petri plates when scoring the revertants at dose-levels ≥ 2500 μg/plate, toward the three strains used.
A moderate to marked toxicity was noted at dose-levels ≥ 100 μg/plate in the TA 98 and TA 102 strains without S9 mix and at dose-levels ≥ 500 μg/plate in the TA 98 and TA 102 strains with S9 mix and in the TA 100 strain, with and without S9 mix.
MUTAGENICITY EXPERIMENTS
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Since the test item was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Without S9 mix, a moderate to marked toxicity was generally noted at dose-levels ≥ 31.3 μg/plate in the TA 1537 strain, ≥ 62.5 μg/plate in the TA 1535, TA 98 and TA 102 strains, and ≥ 125 μg/plate in the TA 100 strain.
With S9 mix, a moderate to marked toxicity was generally observed at dose-levels ≥ 125 μg/plate in the TA 1537 strain, ≥ 250 μg/plate in the TA 100 and TA 102 strains, at 375 μg/plate in the TA 98 strain, and at 500 μg/plate in the TA 1535 strain.
The test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix, in any of the five strains. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Test substance Oleyl diamine, dioleate was found to be non-mutagenic in the Salmonella typhimurium reverse mutation assay. - Executive summary:
The objective of this study was to evaluate the potential of the test item INIPOL 002 (batch No. 11638106, purity: 97.40%) to induce reverse mutation in Salmonella typhimurium.
The study was performed according to the international guidelines (OECD 471, Commission Directive No. B13/14) and in compliance with the Principles of Good Laboratory Practice Regulations.
Methods
A preliminary toxicity test was performed to define the dose-levels of INIPOL 002 to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).
Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to five dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item INIPOL 002 was dissolved in ethanol.
The dose-levels of the positive controls were as follows:
without S9 mix:
• 1 μg/plate of sodium azide (NaN3): TA 1535 and TA 100 strains,
• 50 μg/plate of 9-Aminoacridine (9AA): TA 1537 strain,
• 0.5 μg/plate of 2-Nitrofluorene (2NF): TA 98 strain,
• 0.5 μg/plate of Mitomycin C (MMC): TA 102 strain.
with S9 mix:
• 2 μg/plate of 2-Anthramine (2AM): TA 1535, TA 1537, TA 98 and TA 100 strains,
• 10 μg/plate of 2-Anthramine (2AM): TA 102 strain.
Results
Since the test item was toxic in the preliminary test, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.
Without S9 mix, the selected treatment-levels ranged from 3.91 to 500 μg/plate.
A moderate to marked toxicity was generally noted at dose-levels ≥ 31.3 μg/plate in the TA 1537 strain, ≥ 62.5 μg/plate in the TA 1535, TA 98 and TA 102 strains, and ≥ 125 μg/plate in the TA 100 strain.
With S9 mix, the selected treatment-levels ranged from 15.6 to 500 μg/plate.
A moderate to marked toxicity was generally observed at dose-levels ≥ 125 μg/plate in the TA 1537 strain, ≥ 250 μg/plate in the TA 100 and TA 102 strains, at 375 μg/plate in the TA 98 strain, and at 500 μg/plate in the TA 1535 strain.
The test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix, in any of the five strains.
The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Conclusion
Under our experimental conditions, the test item INIPOL 002 (batch No. 11638106, purity: 97.40%) did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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