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EC number: 263-179-6 | CAS number: 61791-46-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018-07-03 to 2018-07-07
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 4 February 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DB-ALM (INVITTOX) Protocol 154: Direct Peptide Reactivity assay (DPRA) for skin sensitisation testing
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SANCO Guideline 3030/99
- Version / remarks:
- rev.4, July 11, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- EC Number:
- 263-179-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Cas Number:
- 61791-46-6
- Molecular formula:
- n.a
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
In chemico test system
- Details on the study design:
- The reactivity of a test chemical and synthetic cysteine or lysine containing peptides was evaluated by combining the test chemical with a solution of the peptide (reaction samples) and monitoring the remaining concentration of the peptide following 24 ± 2 hours of interaction time at room temperature (25 ± 2.5°C). The peptide is a custom material containing phenylalanine to aid in detection and either cysteine or lysine as the reactive centre. Relative concentrations of the peptide following the 24 hour reaction time were determined by HPLC with gradient elution and UV detection at 220 nm. Samples were prepared and analysed in triplicates in batches to keep the total HPLC analysis time less than 30 hours.
Results and discussion
- Positive control results:
- The positive control replicates (Cinnamaldehyde) showed the expected percent peptide depletion values within acceptable limits (68.53% with cysteine peptide and 51.63 % mean percent lysine peptide depletion).
In vitro / in chemico
Results
- Key result
- Parameter:
- other: average peptide depletion of both peptides [%]
- Value:
- 2.69
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
Prior to routine use of the method, TOXI-COOP ZRT. demonstrated technical proficiency in a separate study (Study number.: 392-442-2996) by correctly obtaining the expected DPRA prediction for 10 proficiency substances as recommended in the OECD TG 442C guideline.
ACCEPTANCE OF RESULTS: All acceptance citeria are fulfilled.
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes (cystein peptide depletion value of 68.53% (SD 2.03%) and a mean lysine peptide depletion of 51.63% (SD 2.35%))
- Acceptance criteria met for variability between replicate measurements: Yes (SD for the test chemical replicates was 7.14% for percent cysteine depletion and 0.85% for the percent lysine peptide depletion)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Results obtained from this in chemico Direct Peptide Reactivity Assay with the test item Ethanol, 2,2’-iminobis-, N-tallow alkyl derivs., N-oxides indicated that the test item has no or minimal reactivity towards the synthetic peptides, thus is not a potential skin sensitizer.
- Executive summary:
The skin sensitisation of the test item Ethanol, 2,2’-iminobis-, N-tallow alkyl derivs., N-oxides was evaluated according to OECD guideline 442C (Direct Peptide Reactivity Assay, DPRA).
At the beginning of the assay the solubility of the test chemical was assessed and acetonitrile was chosen as the appropriate solvent with which the test item formed a homogenous solution. Concentrations of the synthetic cysteine and lysine peptides following the 24 hours incubation time were determined by HPLC with gradient elution and UV detection at 220 nm.
Cysteine and lysine depletion values were to be used to categorize the test chemical in one of the four classes of reactivity. No co-elution was observed with either cysteine or lysine peptide, therefore the Cysteine 1:10 / Lysine 1:50 prediction model was used. The threshold of 6.38 % mean percent peptide depletion supported the discrimination between skin sensitisers and non-sensitisers in the framework of Integrated Approaches to Testing and Assesment (IATA).
The positive control replicates showed the expected percent peptide depletion values within acceptable limits (68.53% with cysteine peptide and 51.63 % mean percent lysine peptide depletion). The back-calculated values of the reference control replicates were within the expected molarity concentration range of 0.50 ± 0.05 mM. The experiment was considered to be valid.
The percent cysteine peptide depletion value of Ethanol, 2,2’-iminobis-, N-tallow alkyl derivs., N-oxides was 3.58 % while the percent lysine peptide depletion was 1.79 %. The Cysteine 1:10 / Lysine 1:50 prediction model was used for the discrimination between sensitisers and non-sensitisers based on the threshold of 6.38 %. The average percent peptide depletion value of the test item was 2.69 % which does not exceed the threshold. Results obtained from this in chemico Direct Peptide Reactivity Assay with the test item Ethanol, 2,2’-iminobis-, N-tallow alkyl derivs., N-oxides indicated that the test item has no or minimal reactivity towards the synthetic peptides, thus is not a potential skin sensitizer.
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