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Diss Factsheets
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EC number: 257-406-8 | CAS number: 51772-35-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14 Feb 2012 - 06 Mar 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (2009)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine
- EC Number:
- 257-406-8
- EC Name:
- N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine
- Cas Number:
- 51772-35-1
- Molecular formula:
- C24H29N
- IUPAC Name:
- N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine
- Details on test material:
- - Physical state: solid/white
- Analytical purity: 99.0 g/100 g determined by 1H-MR spectroscopy
- Expiration date of the lot/batch: July 15, 2015
- Storage condition of test material: Room temperature; avoid temperatures > 35°C
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- reconstructed three dimensional human epidermis model (EpiDerm™)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: minimally moistened with PBS
- Details on test system:
- EpiDerm TM 200 kit: MatTek ln Vitro Life Science Laboratories, Bratislava, Slovakia containing: 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® 0 1 cm
Tissue for MTTreduction control: Epi-200 tissue that is killed by freezing at -20°C
Assay medium: Dulbecco's modified eagle's medium (DMEM); for the assay and for diluting MTT
Wash buffer: Dulbecco's phosphate buffered saline (P8S), w/o Ca2+ , Mg2+
Extracting agent: lsopropanol p.a.
Detection agent: 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT), 1.0 mg I ml assay medium - Amount/concentration applied:
- 25 μL de-ionized water was applied first. Thereafter, a bulk volume of 25 μL of the solid test material was applied with a sharp spoon and homogeneously distributed with the water.
- Duration of treatment / exposure:
- 1h
- Number of replicates:
- three tissue samples used each for test sample and controls
Test animals
- Details on test animals or test system and environmental conditions:
- N/A
Test system
- Controls:
- other: Control tissue used for positive and negative controls
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of three tissues
- Run / experiment:
- assay with the test article
- Value:
- 102
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results
Test material | Tissue 1 | Tissue 2 | Tissue 3 | mean | SD | |
negative control (NC) | mean OD570 |
1.824 | 2.069 | 1.717 | 1.87 | |
viability [% of NC] |
97.5 |
110.7 | 91.8 | 100 | 9.67 | |
test article | mean OD570 |
1.735 | 2.068 | 1.911 | 1.905 | |
viability [% of NC] |
92.8 | 110.6 | 102.2 | 102 | 8.92 | |
positive control (PC) | mean OD570 |
0.165 | 0.168 | 0.171 | 0.168 | |
viability [% of NC] |
8.8 | 9 | 9.1 | 9 | 0.17 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results it was concluded, that the test substance does not show a skin irritation potential in the EpiDerm(TM) irritation test under the test conditions chosen.
- Executive summary:
The test article's potential to cause dermal irritation was assessed in an in vitro irritation test according to OECD guideline 439 and in compliance with GLP. To that end, a single topical application of 25 μL bulk volume (about 14 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™) was analyzed. Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 102%. Based on the observed results it was concluded, that the test substance does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.
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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