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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 948-040-6 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 March - 21 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EC) No 761/2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N,N',N'-tetrabutylmethylenediamine
- EC Number:
- 243-678-5
- EC Name:
- N,N,N',N'-tetrabutylmethylenediamine
- Cas Number:
- 20280-10-8
- Molecular formula:
- C17H38N2
- IUPAC Name:
- dibutyl[(dibutylamino)methyl]amine
- Reference substance name:
- Dibutylamine
- EC Number:
- 203-921-8
- EC Name:
- Dibutylamine
- Cas Number:
- 111-92-2
- Molecular formula:
- C8H19N
- IUPAC Name:
- 1-Butanamine, N-butyl-
- Test material form:
- liquid
- Details on test material:
- Clear, light yellow liquid
Storage: 2 to 8 °C, in the dark
Expiry date: 01-Jan-19
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 2-8 ºC, in darkness
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No, investigations of MTT and colour interference concluded that the test item did not interfere with the test system.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: N/A
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): Applied as supplied
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): N/A
OTHER SPECIFICS: N/A
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM SIT (EPI-200) three-dimensional human skin model, (lot 25800) comprising a reconstructed epidermis with a functional stratum corneum, supplied by MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Source strain:
- other: N/A
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- Guideline specific test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm SIT (EPI-200) 3D human skin model (supplied by MatTek In Vitro Life Science, Slovakia)
- Tissue batch number(s): 25803
- Production date: 05 April 2017
- Shipping date: 05 April 2017
- Delivery date: 05 April 2017
- Date of initiation of testing: 05 April 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 ºC
- Temperature of post-treatment incubation (if applicable): 37 ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsed with PBS (minimum of 3 rinses)
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: not reported
- Wavelength: 570 nm
- Filter: Not reported
- Filter bandwidth: Not reported
- Linear OD range of spectrophotometer: Not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: acceptable (provided in CoA; OD540-570 between 1.0-3.0)
- Barrier function: acceptable (provided in CoA; ET-50 between 4.77 and 8.72 h)
- Contamination: acceptable (provided in CoA; no contamination - screened for HIV-1-virus; Hep B and Hep C; bacteria, yeast and other fungi)
NUMBER OF REPLICATE TISSUES: 3 per test group
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- n/a
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after exposure is ≤ 50 %, realtive to the negative control.
- The test substance is considered to be non-irritant to skin if the viability after exposure is > 50 %, relative to the negative control.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: N/A, as per OECD 439 guidance - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration (if solution): Undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): phosphate buffered saline (PBS) - concentration not reported
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5 % w/v - Duration of treatment / exposure:
- 60 mins exposure
- Duration of post-treatment incubation (if applicable):
- Post exposure and rinsing the tissues were placed on the appropriate medium and incubated for 41 hours and 20 minutes.
Upon completion of the recovery period, each tissue was rinsed with PBS before being placed on 0.3 mL of 1 mg/mL MTT in PBS and incubated for three hours at 37 ºC. Following MTT immersion, the samples were extracted in isopropanol for 2 hours. - Number of replicates:
- 3 per test group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three test item replicates
- Value:
- 3.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The OD values for the negative controls were between ≥0.8 and ≤2.8 (1.117).
- Acceptance criteria met for positive control: Viability of tissues was ≤ 20 % (4.9 %).
- Acceptance criteria met for variability between replicate measurements: Yes, ≤18 % (ca. 6 and 7 % for the negative and positive control groups, respectively).
- Range of historical values if different from the ones specified in the test guideline: Both negative and positive control values fall within the current historical control ranges.
Any other information on results incl. tables
Table 2 Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | OD570 of tissues (corrected mean) | Relative individual tissue viability (%) | Relative mean viability (%) | ± SD of Relative mean viability (%) | % COV Relative mean viability (%) |
Negative Control Item | 1.191 | 106.6 | 100 | 5.848 | 5.848 |
1.091 | 97.7 | ||||
1.068 | 95.7 | ||||
Positive Control Item | 0.059 | 5.3 | 4.9 | 0.329 | 6.713 |
0.052 | 4.6 | ||||
0.054 | 4.8 | ||||
Test Item | 0.038 | 3.4 | 3.5 | 0.557 | 15.907 |
0.034 | 3.0 | ||||
0.046 | 4.1 |
OD= Optical Density
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100 %
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of this study the test substance is considered to be irritant to the skin and is classified as Category 2 in accordance with UN GHS and EU CLP regulation.
- Executive summary:
OECD 439 (2017) - The skin irritation potential of Reaction mass of N,N,N',N'-tetrabutylmethylenediamine and dibutylamine was assessed using an EpiSkin Reconstructed Human Epidermis (RHE) Model Kit in accordance with OECD Guidance 439 and GLP.
Triplicate tissues were exposed to the test item for 60 minutes. At the end of the exposure period the test item was rinsed and the tissues incubated for a further 40 h in the presence of maintenance solution which would be used for possible inflammatory mediator determination. Each tissue was then loaded with MTT for 3 h and any resultant colour extracted. After incubation and extraction with isopropanol, the solutions were aliquoted for absorbance measurements. Absorbency at 570 nm of each well was measured using a spectrophotometer.
Mean viability of tissues exposed to the test substance after 60 minutes were 3.5 %. It was considered unnecessary to perform IL-1a analysis as the results of the MTT test were unequivocal. The quality criteria required for acceptance of the results was met.
Under the conditions of this study the test substance is considered to be irritant to the skin and is classified as Category 2 in accordance with UN GHS and EU CLP regulation.
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.