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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-279-3 | CAS number: 68424-19-1 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid triethanol amine salt and SDA Reporting Number: 11-006-14.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a key Ames test no increase in mutations were observed in different Salmonella typhimureum strains with and without metabolic activation up to 5000 µg/plate. In a key mammalian gene mutation test in HPRT cells, the test item did not induce mutations in the absence and presence of metabolic activation when tested up to cytotoxic concentrations of 250 µg/mL. Finally, in a key in vitro Micronucleus study in human peripheral lymphocytes, no chromosome damage was observed in the absence and presence of metabolic activation when tested up to cytotoxic concentrations of 250 µg/mL (4 and 20h exposure time without metabolic activation ) and up to 250 µg/mL (4h exposure with metabolic activation).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to internationally accepted test guidelines and is considered relevant, adequate and reliable.
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use, Current Step 4 version dated November 9, 2011.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine
- 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:
- S9-mix
- Test concentrations with justification for top dose:
- Preliminary test: 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg/plate
Main test: 31.6, 100, 316, 1000, 3160 and 5000 µg/plate
The test item was examined in a preliminary cytotoxicity test without metabolic activation in test strain TA100 employing a plate incorporation test. Ten concentrations of 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate were tested. No signs of cytotoxicity were noted up to the top concentration of 5000 µg/plate. Hence, 5000 µg test item/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test item was completely dissolved in dimethyl sulfoxide (DMSO) . - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide in aqua ad iniectabilia
- Remarks:
- 10 µg/plate TA 1535, TA 100 without S9
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene in DMSO
- Remarks:
- 10 µg/plate TA 98 without S9
- Positive controls:
- yes
- Positive control substance:
- other: Mitomycin in DMSO
- Remarks:
- 10 µg/plate TA 102 without S9
- Positive controls:
- yes
- Positive control substance:
- other: 9-amino-acridine in ethanol, abs.
- Remarks:
- 100µg/plate TA 1537 without S9
- Positive controls:
- yes
- Positive control substance:
- other: benzo(a)pyrene in DMSO
- Remarks:
- 10 µg/plate TA 98, TA 102, TA 1537 with S9
- Positive controls:
- yes
- Positive control substance:
- other: 2-amino-anthracene in DMSO
- Remarks:
- 2 µg/plate TA 100, TA 1535 with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
1st experiment: in agar (plate incorporation)
2nd experiment: preincubation
DURATION
1st experiment:
- Exposure duration / Selection time: 48 to 72 hours
2nd experiment:
- Preincubation period: 20 minutes
- Exposure duration / Selection time: 48 to 72 hours
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity is evidenced by a reduction in the number of spontaneous revertants, a clearing or diminution of the background lawn or by the degree of survival of the treated cultures. Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the vehicle control and/or a scarce background lawn. - Evaluation criteria:
- In the laboratory, a test item is considered to show a positive response if
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) compared with the vehicle control to at least 2-fold of the vehicle control for TA98, TA100 and TA102 and 3-fold of the vehicle control for TA1535 and TA1537 in both independent experiments;
Or
- a concentration-related increase of the revertants is observed. The Spearman's rank correlation coefficient may be applied.
- Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the AMES test.
Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the solvent control and/or a scarce background lawn. - Statistics:
- The Mann and Whitney test (p ≤ 0.05) may be used to determine statistical significance.
The Spearman's rank correlation coefficient may be applied. - 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- No signs of cytotoxicity were noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation up to the top concentration of 5000 µg test item/plate in all test strains.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
The test item was examined in a preliminary cytotoxicity test without metabolic activation in test strain TA100 employing a plate incorporation test. Ten concentrations of 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate were tested. No signs of cytotoxicity were noted up to the top concentration of 5000 µg/plate. Hence, 5000 µg test item/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
History Profile of Negative and Positive Control Values (n = 37 studies) of the year 2012 is provided in the study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No signs of cytotoxicity were noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation up to the top concentration of 5000 µg test item/plate in all test strains. The reduction of the number of revertants by more than 50% in test strain TA1537 in the plate incorporation test without metabolic activation at concentrations of 31.6 and 1000 µg test item/plate and in the preincubation test with metabolic activation at 1000 and 3160 µg/plate is considered to be caused by the high variation in individual counts and not due to cytotoxicity. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results: negative
Under the present test conditions the Fatty acids, C16-18 and C18-unsatd., compds. with triethanolaminetested up to a concentration of 5000 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation. - Executive summary:
The Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was examined in the 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
The test item was completely dissolved in sulfoxide (DMSO). DMSO was used as vehicle control.
Preliminary test
The test item was examined in a preliminary cytotoxicity test without metabolic activation in test strain TA100 employing a plate incorporation test. Ten concentrations of 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate were tested. No signs of cytotoxicity were noted up to the top concentration of 5000 µg/plate. Hence, 5000 µg test item/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Main study
Six concentrations of 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
Cytotoxicity
No signs of cytotoxicity were noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation up to the top concentration of 5000 µg test item/plate in all test strains.
Mutagenicity
No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to a concentration of 5000 µg/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test).
The results for the vehicle controls were within the range of historical control data of the laboratory. The positive control items showed a significant increase in the number of revertant colonies compared to the vehicle controls of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions the Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine tested up to a concentration of 5000 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Bacterial reverse mutation
Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was examined in the 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (Flügge, 2013d). In on a preliminary cytotoxicity test without metabolic activation in test strain TA100 , ten concentrations of 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate were tested. No signs of cytotoxicity were noted up to the top concentration of 5000 µg/plate, hence 5000 µg test item/plate was chosen as top concentration for the main study in the plate incorporation test and in the preincubation test. In the main study, 31.6, 100, 316, 1000, 3160 and 5000 µg test item/plate employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation, did not lead to cytotoxicity nor increased mutation rates. The results for the vehicle controls were within the range of historical control data of the laboratory, whereas positive control items showed a significant increase in the number of revertant colonies compared to the vehicle controls of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system. In conclusion, under the present test conditions the Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine tested up to a concentration of 5000 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
In conclusion, the registered substance did not exert mutagenic potential in bacterial strains.
Mammalian gene mutation
Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was tested for mutagenic potential in a gene mutation assay in cultured mammalian cells (V79, genetic marker HPRT) both in the presence and absence of metabolic activation (Flügge, 2013e). The duration of the exposure with the test item was 4 hours or 24 hours in the experiments without S9 mix and 4 hours in the experiments with S9 mix.
The test item was completely dissolved in dimethylsulfoxide (DMSO), which also served as the vehicle control. In a preliminary experiment without and with metabolic activation test item concentrations of 10, 25, 100, 250, 1000, 2500 and 5000 µg/mL medium were employed. Pronounced cytotoxicity in form of decreased plating efficiency was noted starting at a concentrations of 250 µg/mL without and with metabolic activation (24-h or 4-h exposure). Test item precipitation was noted starting at a concentration of 1000 µg/mL, hence, 250 µg test item/mL was employed as the top concentration for the mutagenicity tests in the absence and in the presence of metabolic activation. Concentrations of 15.63, 31.3, 62.5, 125 or 250 µg test item/mL were selected for the experiments without and with metabolic activation, respectively. Cytotoxicity in form of decreased plating efficiency (PE1) and (PE2) was noted in the first and second experiment at the concentration of 250 µg/mL in the absence and presence of metabolic activation. In both experiments, the mutation frequency of the cultures treated were within the normal range of the vehicle controls. The positive controls EMS (ethyl methanesulfonate) in the direct test and DMBA (9,10-dimethyl-1,2-benzanthracene) caused a pronounced increase in the mutation frequencies.
In conclusion, the registered substance did not exert potential mutagenicity in mammalian cell mutagenicity test.
Chromosomal aberration
Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was assayed in an in vitro micronucleus test using human peripheral lymphocytes both in the presence and absence of metabolic activation (Flügge, 2013f). The test was carried out employing 2 exposure times without S9 mix: 4 and 20 hours, and 1 exposure time with S9 mix: 4 hours (carried out twice). The harvesting time was 20 hours after the end of exposure. The test item was diluted with dimethylsulfoxide (DMSO), which also served as the vehicle control.
The concentrations employed were chosen based on the results of a cytotoxicity study. In this preliminary experiment without and with metabolic activation test item concentrations of 10, 25, 100, 250, 1000, 2500 and 5000 µg/mL medium were employed. Pronounced to complete cytotoxicity was noted at concentrations of 250 µg test item/mL and higher in the experiment without and with metabolic activation. Hence, 250 µg/mL was employed as the top concentration for the mutagenicity tests without and with metabolic activation.
In the main study concentrations of 31.3, 62.5, 125 or 250 µg test item/mL medium (4-h or 20-h exposure withour metabolic activation and 4 h with metabolic activation) did not lead to increase in micronuclei up to the cytotoxic concentrations. In the same test, Mitomycin C and cyclophosphamide induced significant chromosomal damage and colchicine induced significant damage to the cell division apparatus, respectively, therefore, the test is considered valid.
In conclusion, the registered substance did not exert potential clastogenic activity in human peripheral lymphocytes.
Conclusion
Standard information requirements according to REACH Guidance Part 3 R7a were fulfilled for genotoxicity testing, including bacterial and mammalian mutagenicity and chromosomal aberration. Based on the available results, there were no indications of mutagenicity or genotoxicity, and no further testing is needed. The substance can be considered to have no mutagenic or genotoxic potential.
Justification for selection of genetic toxicity endpoint
Although the bacterial gene mutation study was selected, the mammalian gene mutation and chromosomal aberration tests are equivalent endpoints.
Justification for classification or non-classification
Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for genetic toxicity.
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.