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EC number: 811-460-4 | CAS number: 53606-41-0
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Protocol for: INVITRO EpiDermTM SKIN IRRITATION TEST For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm, Model EPI-200-SIT, Rev. 26/3/2012,1-37
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methoxy-5-nitrophenyl acetate
- Cas Number:
- 53606-41-0
- Molecular formula:
- C9H9NO5
- IUPAC Name:
- 2-methoxy-5-nitrophenyl acetate
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- The reconstructed human epidermal model EpiDerm™ (EPI-200, MatTek, Ashland, USA) consists of normal human-derived epidermal keratinocytes, which have been cultured to form a multilayered highly differentiated model of the human epidermis. The EpiDerm™ System is manufactured according to defined quality assurance procedures.
The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts and shipped as kits, containing tissues on shipping agarose together with the necessary amount of culture media
Test system
- Type of coverage:
- other: topical
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Details on study design:
- The test consists of a topical exposure of the neat test chemical to a reconstructed human epidermis (RhE) model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyltetrazolium-bromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of the viability of tissues exposed to chemicals in comparison to negative controls (treated with PBS) is used to predict the skin irritation potential. Classification of skin irritation potential is performed according to criteria. The viability of tissues is measured as optical density (OD) of the formazan extracts using a spectrophotometer at 570 nm. Relative cell viability is calculated for each tissue as % of the mean OD value of the negative control tissues.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Under the described experimental design (see any other information on results part), average viability of tissues treated by the test substance was 102.7 % of negative control average value, i.e. viability was > 50 %. The effect of the test substance was negative in EpiDermTM model.
According to the classification criteria, the test substance is considered to have no category in regard to skin irritation.
Any other information on results incl. tables
In vitro alternatives that have been validated and accepted may also be used to help in classification decisions making (see Regulation (EC) 1272/2008, 3.2. Skin corrosion/ irritation, 3.2.2. Classification criteria for substances).
For further classification the relative cell viability is calculated for each tissue as % of the mean of the negative control tissues viability, which is set at 100 %.
The cut-off values for the prediction of irritation are given below; these values are stated in EU Method B.46., part 2.2. INTERPRETATION OF RESULTS:
The test substance is considered to be irritant to skin in accordance with UN GHS 1 category 2:
(i) if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50 %.
The test substance is considered to have no category:
(ii) if the tissue viability after exposure and post-treatment incubation is more than (>) 50 %.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- the test substance is considered to have no category in regard to skin irritation.
- Executive summary:
Test substance, 2-methoxy-5-nitrophenyl acetate, was assayed for the in vitro skin irritation in human epidermal model EpiDermTM. The test was performed according to the Method B.46. In vitro skin irritation: Reconstructed human epidermis model test and Protocol for: In Vitro EpiDermTM Skin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT (see par. 1.4, (1), (3)). After pre-incubation of tissues, 25 mg of the test was placed directly atop to the previously moistened tissue so it covered all tissue surfaces. Length of exposition was 60 minutes. Three tissues were used for every concentration and controls. After removal of the test substance from tissues, tissues were post incubated for 42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues. Under the above-described experimental design, average viability of tissues treated by the test substance was 102.7 %, i.e.viability was > 50 %. The effect of the test substance was negative in EpiDermTM model (the tissue was not damaged). According to the classification criteria given in chapter 3.9., the test substance is considered to have no category in regard to skin irritation.
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