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EC number: 240-610-6 | CAS number: 16545-00-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Version / remarks:
- 10.2 Deviations from the Guideline
Due to a programming error (the UV-lamp was not on) the peptide calibration samples and Co-elution controls for the Lys-peptide assay were measured after the incubated samples.
This was considered uncritical because the applicability of the calibration and stability of samples was verified using reference controls A and B. - Deviations:
- yes
- Remarks:
- The deviation was considered uncritical
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The direct peptide reactivity assay (DPRA) is an in chemico assay to quantify the reactivity of the test item towards cysteine and lysine containing peptides. This reactivity is related to the skin sensitisation potential.
This study was performed in order to estimate the skin sensitisation potential of Bis[2-(diethylamino)ethyl]adipate using a peptide model.
To quantify the sensitisation potential, the depletion of the cysteine and lysine containing peptides caused by known amounts of the test item was measured using HPLC.
The assay was used for supporting the discrimination between skin sensitizers (i.e. UN GHS Category 1) and non-sensitizers in accordance with the UN GHS. A categorization in the sub-categories 1 A and 1 B is not possible.
Test material
- Reference substance name:
- Bis[2-(diethylamino)ethyl] adipate
- EC Number:
- 240-610-6
- EC Name:
- Bis[2-(diethylamino)ethyl] adipate
- Cas Number:
- 16545-00-9
- Molecular formula:
- C18H36N2O4
- IUPAC Name:
- 1,6-bis[2-(diethylamino)ethyl] hexanedioate
- Reference substance name:
- 2-diethylaminoethanol
- EC Number:
- 202-845-2
- EC Name:
- 2-diethylaminoethanol
- Cas Number:
- 100-37-8
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 2-(diethylamino)ethanol
- Test material form:
- liquid
Constituent 1
impurity 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Run / experiment:
- mean
- Parameter:
- other: Mean peptide depletion [%]
- Value:
- 3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
According to the test guideline, the reactivity is classified as “high”, “moderate”, “low” or “minimal” using the Cysteine 1:10/Lysine 1:50 prediction model shown in Table8.4–a.
Table8.4–a Evaluation of results according to the Cysteine 1:10/Lysine 1:50 prediction model
Mean peptide depletion |
Reactivity Class |
DPRA Prediction |
0 – ≤ 6.38 |
Minimal |
Negative |
> 6.38 – ≤ 22.62 |
Low |
Positive |
> 22.62 – ≤ 42.47 |
Moderate |
|
> 42.47 - ≤ 100 |
High |
The mean peptide depletion in the Lys-peptide and Cys-peptide assay was 3.00 %, therefore the test item was classified with:
DPRA Prediction: Negative
Reactivity class: Minimal
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All acceptance criteria were fulfilled, therefore the test was considered valid. The DPRA prediction for the test item Bis[2-(diethylamino)ethyl]adipate was negative with reactivity class minimal according to the Cysteine 1:10/Lysine 1:50 prediction model.
According to the test guideline, a second run should be considered to verify the result if the mean percent depletion falls in the range of 3 % to 10 % for the cysteine 1:10/lysine 1:50 prediction model or the cysteine percent depletion falls in the range of 9 % to 17 % for the cysteine 1:10 prediction model. This was considered not necessary because the mean depletion was exactly at the lower border where a second run is recommended, but well below the limit regarding the cysteine depletion alone evaluated with the Cysteine 1:10 model (measured depletion: 5.05 % compared to recommended repetition of the experiment in the range 9 % to 17 %).
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made. - Executive summary:
The study was performed in order to evaluate the reactivity of the test itemBis[2-(diethylamino)ethyl]adipatetowards cysteine (Cys-) and lysine (Lys-) containing peptides. A test item solution in acetonitrile was incubated 24 ± 2 h at 24.6 - 24.8 °C together with cysteine and lysine peptides, respectively, and the peptide concentration after the incubation was measured using HPLC-UV.
Three replicates were prepared using 1:10 and 1:50 molar ratio of the test item with the Cys- and Lys-peptide, respectively. Triplicate samples of the solvent without test item were incubated and measured in parallel.
The peptide depletion values after incubation are shown in Table 3-a:
Table3-a Results
Cys-peptide
depletion [%]Lys-Peptide
depletion [%]Mean peptide
depletion [%]5.05
0.96
3.00
The DPRA predicition is “negative” with minimal reactivity according to the Cysteine 1:10/Lysine 1:50 prediction model.
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