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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 204-826-4 | CAS number: 127-19-5
- 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study with acceptable restrictions (no details about the test substance; skin temperature 34 °C [32 °C recommended]; 3 replicates but at least 4 recommended).
Data source
Reference
- Reference Type:
- publication
- Title:
- Permeability of commercial solvents through living human skin
- Author:
- Ursin C, Hansen CM, Van Dyk JW, Jensen PO, Christensen IJ, Ebbehoej J
- Year:
- 1 995
- Bibliographic source:
- Am Ind Hyg Assoc J 56: 651-660
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Remarks:
- No details about the test substance; skin temperature 34°C (instead of 32°C); 3 replicates instead of 4
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N-dimethylacetamide
- EC Number:
- 204-826-4
- EC Name:
- N,N-dimethylacetamide
- Cas Number:
- 127-19-5
- Molecular formula:
- C4H9NO
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: dimethylacetamide (DMAC)
- Composition of test material, percentage of components: highest available commercial quality
No further details available. - Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Skin specimen of women were used; living skin was obtained during plastic surgery of the breast.
Administration / exposure
- Type of coverage:
- other: in vitro cell; cap prevented pressure build-up in the challenge half cell, containing the test substance
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- Sampling was performed 0.16, 0.33, 0.5 (or 0.66), 1, 2, 4, 6 h after application of the test substance (0.5 mL of the receptor fluid).
- Doses:
- Undiluted test substance was placed in the challenge half of the cell.
- No. of animals per group:
- 3 measurements were conducted using the skin samples of the same donor.
- Control animals:
- yes
- Remarks:
- control for leakage of skin
- Details on study design:
- The exposed skin area was 0.64 cm².
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: skin obtained during plastic surgery of the breast
- Ethical approval if human skin: no data
- Type of skin: skin of the breast
- Preparative technique: dermal tissue removed from the epidermis using a Downs-Watson dermatome
- Thickness of skin in the cell: 300-600 µm
- Membrane integrity check: yes, relative permeability was tested with 3H water for 2 h.
- Viability test: Skin viability was detemined prior to experiments by assessing the ability of the skin cells to engage in DNA synthesis as measured by incorporation of BrdU.
PRINCIPLES OF ASSAY
- Diffusion cell: Franz diffusion cell
- Receptor fluid: isotonic, nourished, saline solution (Dulbecco's medium) with gentamycin (50 µg/mL)
- Solubility od test substance in receptor fluid: yes
- Static system: yes
- Test temperature: 37 °C of the bath resulting in 34 °C of the skin
- Occlusion and humidity: cap prevented pressure build-up in the challenge half cell.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Remarks:
- (in vitro)
- Dermal irritation:
- not specified
- Remarks:
- (see freetext for cell viability at termination)
- Absorption in different matrices:
- not applicable, in vitro
- Total recovery:
- not applicable, in vitro
Percutaneous absorption
- Remarks on result:
- other: at steady state
- Remarks:
- Permeability constant: 107 ± 19 g/m²/h (mean ± SD, n = 3)
- Conversion factor human vs. animal skin:
- Human skin was used.
Any other information on results incl. tables
Prior to the permeability test, no leakage of skin and cell viability was given. Skin cell viability was checked after the permeability test (DNA synthesis as measured by incorporation of BrdU);
Result: no labelling of cells (not clearly discussed by the authors).
A normalization procedure was used to assess the effects of 3H-water on permeability: after normalisation the permeability constant was 217 ± 84 g/m²/h.
In in vitro skin absorption experiments, the skin of a female donor was used. Viability and skin integrity check was performed prior to experiments. In the diffusion cell the skin was exposed to undiluted test substance and 0.5 mL samples of receptor fluid were collected 0.16, 0.33, 0.5 (or 0.66), 1, 2, 4, 6 h after application of the test substance. Totally 3 trials were performed.
The authors calculated a permeability constant of 107 ± 19 g/m²/h (mean ± SD of 3 trials).
Applicant's summary and conclusion
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.
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