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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 224-160-8 | CAS number: 4219-49-2
- 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:
- 08/01/2018-25/01/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Reference substance name:
- Ethane-1,2-diol
- EC Number:
- 203-473-3
- EC Name:
- Ethane-1,2-diol
- Cas Number:
- 107-21-1
- Molecular formula:
- C2H6O2
- IUPAC Name:
- ethylene glycol
- Reference substance name:
- Ethane-1,2-diyl palmitate
- EC Number:
- 210-826-5
- EC Name:
- Ethane-1,2-diyl palmitate
- Cas Number:
- 624-03-3
- Molecular formula:
- C34H66O4
- IUPAC Name:
- ethane-1,2-diyl dihexadecanoate
- Reference substance name:
- 2-hydroxyethyl palmitate
- EC Number:
- 224-160-8
- EC Name:
- 2-hydroxyethyl palmitate
- Cas Number:
- 4219-49-2
- Molecular formula:
- C18H36O3 & C34H66O4
- IUPAC Name:
- 2-hydroxyethyl hexadecanoate
impurity 1
impurity 2
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- TEST ITEM : 2-hydroxyethyl palmitate
OTHER NAMES / CODES : 2-HYDROXYETHYL PALMITATE LANOL P ECAILLES 35928C
IPL REGISTRATION NUMBER : 171214
BATCH NUMBER : 170301011115
APPEARANCE : white to off-white solid (flakes by naked eyes)
WATER CONTENT : <1%
PURITY / COMPOSITION : > 99% (dry matter) (Sponsor’s information)
SALT / BASE RATIO : unknown
MOLECULAR WEIGHT : unknown
DENSITY : 1.064 ± 0.013 (Sponsor’s information)
CORRECTION FACTOR : none, at the Sponsor’s request
STORAGE CONDITIONS* : room temperature (+20±5°C)
QUANTITY SUPPLIED : unknown
MANUFACTURING DATE : 27/02/2017
ANALYSIS DATE : 08/03/2017
STABILITY UNDER
STORAGE CONDITIONS : 2 years, up to 27/02/2019 for batch 170301011115
EXPIRY DATE : 27/02/2019
Method
- Target gene:
- TA1535 and TA100 : his G 46
TA1537 : his C 3076
TA102 : His G 428
TA98 : his D 3052
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 specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- hepatic microsomes from rat livers induced by Aroclor 1254 – Incubation period: ca. 44 h
- Test concentrations with justification for top dose:
- - First toxicity test : 0, 50, 150, 500, 1500 and 5000 µg/plate. Maximum dose according to OECD Guideline, i.e. 5000 μg/plate. (1 plate / dose).
An important precipitate hindering scoring was observed in all strains both without and with metabolic activation at the 2 highest tested doses of 1500 and 5000 μg/plate. Moderate and slight precipitate was also observed at 500 and 150 μg/plate, respectively. Therefore, due to the important precipitate, the maximum dose retained for the first mutagenicity assay was lowered down to 500 μg/plate in all strains both with and without metabolic activation.
- Mutagenicity test : 0, 5, 15, 50, 150, 500 µg/plate (3 plates / dose) - Vehicle / solvent:
- The solvent used is Tetrahydrofuran (THF).
Prior to the implementation of the toxicity assay, trials for solubility were performed in sterile water, dimethylsulfoxide, ethanol and tetrahydrofuran (THF), at initial concentrations of 50 mg/mL, ranging from 100 to 6.25 mg/mL, ranging from 200 to 12.5 mg/mL, and at 250 mg/mL, respectively, at room temperature, demonstrating that the test is not soluble whatever the solvent. After heating the organic preparations at a temperature below the fusion point of 60-65°C (in accordance with the information provided by the Sponsor Representative), only the 250 mg/mL preparation in THF was clear. Noteworthy, when settled at room temperature, the solution in THF solidified.
For the preliminary toxicity assay, the test item 2-hydroxyethyl palmitate was dissolved in THF (Sigma, batch STBF9606V) at an initial concentration of 250 mg/mL, without following the qs (quantum satis) method (see § 11.1), in order to obtain the top dose of 5000 μg/plate when added at 20 μL/plate. Preparations for treatment were kept at ca. 37°C until treatments in order to anticipate the behavior of the test item in solution when temperature decreases.
For both mutagenicity assays, it was also prepared in THF but at an initial concentration of 25 mg/mL, without following the qs (quantum satis) method (see § 11.1), in order to obtain the top dose of 500 μg/plate when added at 20 μL/plate. As at this concentration the solution in THF did not solidified at room temperature, preparations for treatment were kept at room temperature until treatments.
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 6 plates
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- Without S9 mix
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 6 plates
- Positive control substance:
- benzo(a)pyrene
- other: 2-anthramine, 2 μg/plate without pre-incubation, 1 μg/plate with pre-incubation (TA1535, TA1537, TA98, TA100)
- Remarks:
- With S9 Mix
- Details on test system and experimental conditions:
- Two test of mutagenicity were realised independently : first with metabolic activation, and the second without (with a preincubation period)
MEDIA : agar, supplemented with 10 % of 0.5 mM biotin histidine solution
TOXICITY TEST :
The toxicity assay was carried out in all the strains to be tested under the same conditions as the first mutagenicity test with and without metabolic activation (See below).
NUMBER OF REPLICATIONS : 1 plates per dose (no positive controls included)
DETERMINATION OF THE CYTOTOXICITY : Microscopic examination
MUTAGENICITY TEST :
WIth metabolic activation:
For each strain : 0.1 mL of a bacterial suspension from a culture agitated overnight at ca. 37°C and 20 μL of the test item at the relevant initial concentrations were successively added to 2 mL of top agar, supplemented with 10 % of 0.5 mM biotin histidine solution, maintained in a state of superfusion at ca. 45°C. The content of each tube was agitated, then spread out in a Petri plate containing 20 mL of minimum agar. The plates were then incubated at ca. 37°C for approximately 44 h. At the end of the expression time, colonies of revertants were counted for each plate.
Without metabolic activation : The method was the same as the one described above except that immediately before spreading in the plates, 0.5 mL of the S9-mix metabolic activation system was added in soft agar.
NUMBER OF REPLICATIONS: 3 plates per dose (6 for the positive controls)
- Evaluation criteria:
- Acceptance criteria :
- Determination of the media sterility (The sterility of the test item was berified in a test where it was incubated for 44 hours at 37°C, no bacterial growth was observed, the test item was considered sterile) : ok
- Determination of the efficiency of the metabolic activation : ok
- Validation of the solvent control (The frequencies of spontaneous revertants (solvent controls) were within the limits generally observed under our experimental conditions) : ok
- Determination of the sensitivity of the strains (Statistically and biologically significant increases in the numbers of revertants were observed in the presence of positive reference test substances) : ok
- For the test, 5 doses available, as required by OECD guideline : ok (5 here)
- For the test, At least 2 plates per dose were available for the assessment of mutagenicity : ok (3 here) - Statistics:
- Data were analysed by means of Dunnett's method (Mahon et al, 1989) allowing the comparison of the mean value for each dose to the mean value for the corresponding solvent control. Statistical methods may be used as an aid in evaluating the test results. However, statistical significance should not be the only determining factor for a positive response and biological relevance of the results should be considered firs
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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- Toxicity test : statistically significant decreases were noted in the first assay in strain TA102 at 500 and 150 μg/plate without and with metabolic activation, respectively. Nevertheless, these effects had no meaning in terms of mutagenicity hazard
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- a statistically but not biologically significant increase in the number of revertants was observed at the intermediate dose of 15 μg/plate.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Mutagenicity test :
In two independent assays performed both with and without metabolic activation (the second assay with S9-mix was performed according to the pre-incubation protocol), no biologically significant increases in the mean number of revertants were noted in the five Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 tested, in the presence of 2-hydroxyethyl palmitate.
The test item 2-hydroxyethyl palmitate is thus not mutagenic in these conditions.
In the first assay in strain TA100 in presence of metabolic activation without pre-incubation, a statistically but not biologically significant increase in the number of revertants was observed at the intermediate dose of 15 μg/plate. The mean value for revertants was very slightly higher than the upper bound of the intervals of historical data for negative controls, i.e. 162 vs. 161. However, the threshold ratio for a biologically significant effect (set at 2 in this strain) was not reached, with an induction ratio of 1.3, and no dose-effect relationship was observed. Furthermore, the second assay performed under the more sensitive pre-incubation method was clearly negative. The test item 2-hydroxyethyl palmitate was thus considered as not mutagenic in this experimental condition.
Applicant's summary and conclusion
- Conclusions:
- The mutagenic activity of the test item 2-hydroxyethyl palmitate (Batch 170301011115) sponsored by SEPPIC was assessed by means of the Ames’ test in the five Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 tested both in presence and in absence of metabolic activation, in two independent assays according to OECD guideline (OECD 471, 1997), using the maximum dose compatible with the solubility of the test item in the test system, i.e. 500 μg/plate. The validity criteria for the assay were fulfilled. The study is thus valid. Under these experimental conditions, no mutagenic activity was revealed.
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.