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EC number: 612-975-5 | CAS number: 6225-08-7
- 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:
- 22 December 2016 to 09 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guidelines for the testing of chemicals No. 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”, adopted on 28 July 2015.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-dimethylnonanamide
- EC Number:
- 612-975-5
- Cas Number:
- 6225-08-7
- Molecular formula:
- C11H23NO
- IUPAC Name:
- N,N-dimethylnonanamide
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material:Clariant Produkte Deutschland GmbH and 112-2016-11 D
- Expiration date of the batch:May 2018
- Purity test date: 98.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
FORM AS APPLIED IN THE TEST (if different from that of starting material): Liquid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Human Epidermal Model {EpiDerm™ (EPI-200-SIT)}
- Justification for test system used:
- As recommended in OECD Guideline No. 439, Reconstructed Human Epidermal Model EpiDerm™ (EPI-200-SIT) has been selected as test system for in vitro skin irritation.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE:
- Model used: The Reconstructed Human Epidermal Model - EpiDerm™ (EPI-200-SIT)
- Tissue Lot number(s): 23387
- Production date: 21 Dec-2016
- Delivery date:23 December 2016
- Date of initiation of testing: 23 December 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C
- Temperature of post-treatment incubation (if applicable): 37±1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
washing steps: After 60 minutes of test item exposure, the tissues were rinsed with sterile DPBS by filling and emptying the tissue insert for 15 times to remove any residual test item.
- 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 5 minutes
- Spectrophotometer: Spectromax M5e
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:MTT QC Assay-4 hours, 1.354±0.216
- Barrier function:5.19 hours (Pass)
- Contamination: Sterile (Pass)
NUMBER OF REPLICATE TISSUES: Three
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
The assay met the acceptance criterion as the mean OD570 of the NC tissues is 1.762 which in the range of ≥ 0.8 and ≤ 2.8.
The assay met the acceptance criterion as the mean viability of PC tissues is 2.7% which were ≤ 20% of the negative control tissues and the SD of the three tissues replicates is 0.42 (below the 18%).
The assay met the acceptance criterion as the standard deviation (SD) calculated from individual % tissue viabilities of the 3 identically treated replicates is < 18% i.e., in the range of 0.13 to 17.36
The test item is considered as “irritant” to skin in accordance with UN GHS Category 2, as the tissue viability after exposure and post-treatment incubation is ≤ 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume with unit): 30 µL test item (Genagen PA / N, N-Dimethylnonanamide).
NEGATIVE CONTROL
- Amount(s) applied (volume ): 30 µL each of DPBS (negative control: NC),
POSITIVE CONTROL
- Amount(s) applied (volume ):30 µL of 5% aq. SDS solution (positive control: PC) - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 23 hours and 30 minutes
- Number of replicates:
- Three
Test animals
- Details on test animals or test system and environmental conditions:
- Not Applicable
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Not Applicable
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment
- Value:
- < 50
- 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:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The registration substance, Genagen PA/N,N-Dimethylnonanamide was evaluated for the skin irritation property in an in-vitro test system using reconstructed human epidermal model according to the Guideline OECD 439. A clear reduction of tissue viability was obtained and thus the registration substance was found to be irritating to skin.
- Executive summary:
The registration substance, Genagen PA/N,N-Dimethylnonanamide was evaluated for the skin irritation property in an in-vitro test system using reconstructed human epidermal model according to the Guideline OECD 439. A clear reduction of tissue viability was obtained and thus the registration substance was found to be irritating to skin.
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.
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