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EC number: 937-688-5 | CAS number: 1391530-05-4
- 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:
- Between 09June 2009and 15 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: See Principles of method in the following section
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The principle of the assay is based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-la in the culture medium retained following the 42 hour post-exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the non-irritant result.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-bis[3-(dimethylamino)propyl]-9-nonyl-10-octylnonadecanediamide; N-[3-(dimethylamino)propyl]-9-[2-(7-{[3-(dimethylamino)propyl]carbamoyl}heptyl)-3-[(2E)-oct-2-en-1-yl]-4-pentylcyclohexyl]nonanamide; N-[3-(dimethylamino)propyl]-9-[2-(7-{[3-(dimethylamino)propyl]carbamoyl}heptyl)-3-octyl-4-pentylcyclohexyl]nonanamide
- EC Number:
- 937-688-5
- Cas Number:
- 1391530-05-4
- Molecular formula:
- C46H82N4O2 to C46H94N4O2
- IUPAC Name:
- N,N'-bis[3-(dimethylamino)propyl]-9-nonyl-10-octylnonadecanediamide; N-[3-(dimethylamino)propyl]-9-[2-(7-{[3-(dimethylamino)propyl]carbamoyl}heptyl)-3-[(2E)-oct-2-en-1-yl]-4-pentylcyclohexyl]nonanamide; N-[3-(dimethylamino)propyl]-9-[2-(7-{[3-(dimethylamino)propyl]carbamoyl}heptyl)-3-octyl-4-pentylcyclohexyl]nonanamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST TISSUE: EPISKIN reconstituted human epidermis model
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37 °C
Test system
- Type of coverage:
- other: in vitro testing
- Preparation of test site:
- other: in vitro testing
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control and Sodium Dodecyl Sulphate (SDS) was used as the positive control (this is an in vitro test)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ul test material was added to 2 ml culture media
VEHICLE: none - Duration of treatment / exposure:
- 15 min
- Observation period:
- 42 h incubation after treatment
- Number of animals:
- Triplicate
- Details on study design:
- TEST Tissue was cultured in a 12 well plate.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 15 min after application
SCORING SYSTEM: MTT assay
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: The relative mean viability
- Value:
- 0.988
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Reversibility: other: not applicable. Remarks: This is an in vitro study. (migrated information)
In vivo
- Other effects:
- None
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test material turned blue which indicated that the test material directly reduced MTT and therefore the MTT viability assay was performed in parallel on viable and freeze-killed tissues.
Test Material, Positive Control Material and Negative Control Material
The direct reduction of MTT by the test material was less than 30% of the negative control value. Therefore, the net OD of the test material killed tissue was subtracted from the mean OD of the test material treated viable tissues to obtain the true amount of MTT reduction that reflects metabolic conversion only.
The relative mean viability of the test material treated tissues, following correction for the direct reduction of MTT, was 98.8% after a 15-minute exposure.
Following the 15-minute exposure the test material treated tissues appeared blue which was considered indicative of viable tissue.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was ≤ 40% relative to the negative control treated tissues and the Standard Deviation (SD) value of the % viability was ≤ 20%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥ 0.6 and the SD value of the % viability was ≤ 20%. The negative control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be Non-Irritant.
- Executive summary:
Introduction.The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKIN~~reconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-la in the culture medium retained following the 42 hour post-exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end-point will be used to either confirm a non-irritant result or will be used to override the
non-irritant result.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. The test material was found to have the ability to directly reduce MTT. Therefore it was necessary to apply the test material to a single water-killed tissue to allow for the differentiation of true and false viability. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and
duplicate 200 u1 samples were transferred to the appropriate wells of a pre-labelled
96-well plate. The optical density was measured at 540 nm.
Data are presented in the form of % viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results: The relative mean viability of the test material treated tissues was 98.8% after a 15-minute exposure.
Quality criteria:The quality criteria required for acceptance of results in the test were satisfied.
Conclusion:The test material was considered to be Non-Irritant.
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