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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-062-9 | CAS number: 102-86-3
- 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 20 March 1997 to 16 March 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trihexylamine
- EC Number:
- 203-062-9
- EC Name:
- Trihexylamine
- Cas Number:
- 102-86-3
- Molecular formula:
- C18H39N
- IUPAC Name:
- trihexylamine
- Test material form:
- liquid
- Remarks:
- colorless
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: batch no. 44-0793
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified
- Date of manufacture: May 1996
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions:about 8 month after the date of manufacture
- Solubility and stability of the test substance in the solvent/vehicle: the test item was soluble in the vehicle Precipitation of the test substance
was found from about 2,500 µg/plate onward.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not specified
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: uvrB (S. Typhimurium), uvrA (E. Coli)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Fraction from rat liver which were treated intraperitoneally with Aroclor 1254
- Test concentrations with justification for top dose:
- DOSE RANGE: 15 µg - 5,000 µg/plate (SPT; Salmonella strains) ; 20 µg - 5,000 µg/plate (SPT; E. coli) ; 0.625 µg - 100 µg/plate (PIT; Salmonella strains) ; 4 µg - 2,500 µg/plate (PIT; E. coli)
SPT : Standard plate test ; PIT : Preincubation test
The top dose was chosen as 2500 µg/plate due to the limit of solubility of the test item in vehicle. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Due to limited solubility of the test substance in water, acetone was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical data are available
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): 10E9 bacteria/mL
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 to 72 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): revertant colonies were counted after 48 hours to 72 hours exposure period
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: triplicates were used per condition
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: individual plate count to determine the nomber of revertant colony
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertants ; clearing or diminution of the background lawn (reduced his- or trp - background growth) ; reduction in titer
- Any supplementary information relevant to cytotoxicity: tested for all test groups both with and without S9 mix in all experiments
- Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
-A dose-related and reproducible increase in the nuinber of revertant colonies, i.e. about daubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
-The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in twa experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- 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
- 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
- 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
- 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
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- for preincubation method condition
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect reduced his background growth, decrease in the number of his revertants, reduction in the titer) was observed in the standard plate test depending on the strain and test conditions from about 60 µg - 250 µg/plate onward.
With E. coli only a weak bacteriotoxic effect was observed with S-9 mix only at doses >= 2,500 µg/plate.
In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 0.625 µg - 6.0 µg/plate onward (Salmonella strains) or from about 4 µg - 20 µg/plate onward (E. coli).
Applicant's summary and conclusion
- Conclusions:
- According to the results of the study, the test substance did not led to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in serval experiments carried out independently of each other (standard plate test and preincubation assay). Thus, under the experimental conditions, it is concluded that Tri-N-hexylamine is not a mutagenic agent in a bacterial reverse mutation test in vitro. However, the test item induced bacteriotoxicity effect.
- Executive summary:
In this GLP compliant study, the substance Tri-N-hexylamin was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains in a reverse mutation assay according to OECD TG 471/472 method.
TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA strains were used in this study. Two methods were performed, standard plate test, and preincubation method with and without metabolic activation system. For preincubation method, test item and bacteria were incubated 20 minutes. After 48 hours – 72 hours incubation of the test item with bacteria, number of revertant colony and cytotoxicity were determined.
An increase in the number of his or trp revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. However, bacteriotoxicity occurred under all test conditions.
According to the results of the study, the test substance did not lead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in serval experiments carried out independently of each other (standard plate test and preincubation assay). Thus, under the experimental conditions, it is concluded that Tri-N-hexylamin is not a mutagenic agent in a bacterial reverse mutation test in vitro. However, the test item induced bacteriotoxicity effect.
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.