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EC number: - | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Reconstructed Human Epidermis Test Method of 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: L’Oreal. In Vitro Skin Irritation Test: Human Epidermis Model EPISKIN, EPISKIN Skin Irritation Test 15min - 42 hours, Standard Operating Procedure: February 2009 Version 1.8.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro EpiSkin test
- Strain:
- other: human epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Types of Treatment in the Main Test
- Negative control: Dulbecco's Phosphate Buffered Saline (DPBS), dose volume 10 µl/tissue sample
- Test Substance: BYK-LP N 22655, dose volume 10 µl/tissue sample
- Positive control: 5% Sodium Dodecyl Sulphate (SDS) in purified water, dose volume 10 µl/tissue sample - Duration of treatment / exposure:
- 15 ± 0.5 minutes with the test substance, negative or positive control at room temperature, followed by thorough rinsing of each epidermis unit with Dulbecco's phosphate buffered saline
- Details on study design:
- Test System
EPISKIN human epidermis skin constructs consisting of normal, human-derived epidermal keratinocytes and forming a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum (matrix: collagen type 1 coated with type IV collagen).
Principle of the Test – Main Test
Irritant substances are sufficiently cytotoxic to cause cell deaths in the cell layers. Therefore, cell viability of the multilayers was determined by measurement of mitochondrial dehydrogenase activity assessed by reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) to a soluble, coloured, formazan salt. The degree of formazan salt formation (positively correlated with the degree of cell viability) was measured photometrically (i.e. determination of the optical density of formazan extracts from tissue at 540 nm).
Depending on the percentage of tissue viability attained (compared to negative control viability) a test substance is classified as skin irritating or not skin irritating.
Pre-Tests – Checking for Interference of the Test Substance with the Assay
It was found, that the test material BYK-LP N 22655 itself interacted with MTT. Therefore, additional (killed) tissue controls were used. The test substance BYK-LP N 22655 did not show any potential for colouring water.
Main Test
Each treatment group (test substance, negative/positive controls) comprised 3 live (viable) tissue samples placed into wells of 12 well plates.
Incubation of these tissues before treatment in maintenance medium: ≥ 24 h at 37°C, 5% CO2 in air, in humidified atmosphere , in wells
each containing 2 mL fresh pre-warmed maintenance medium.
Test material administration: Spreading of thin even layer over the epidermal surface.
Termination of 15 ± 0.5 minute exposure period: Removal of residual test material or positive control substance by thorough
rinsing of each epidermis unit with Dulbecco's PBS;
removal of remaining PBS by blotting on absorbent paper.
Posttreatment incubation (all tissue samples) : 42 ± 1 h at 37°C , 5% CO2 in humidified atmosphere, in wells each containing
2 mL fresh pre-warmed maintenance medium
Then MTT incubation: 3 hours (± 5 minutes) at 37°C , 5% CO2 in humidified atmosphere, in wells each containing 2 mL of 0.3 mg/mL MTT.
Formazan extraction (all tissue samples) : Further processing of tissue samples & formazan extraction by vortexing in
acidic isopropanol, 500 µL/sample. The vortexed samples were stored at 2-8°C
protected from light for 48 - 70 hours.
Qantitative determination of optical density: At 540 nm with acidified isopropanol (0.04 N HCl final concentration,
6 x 200 µL) as blanks. - Irritation / corrosion parameter:
- other: other: Negative Control Tissue viability as % of OD of negative controls
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Following 15 ± 0.5 minutes control exposure to DPBS, 42 ± 1 h incubation in fresh maintenance medium, 3 h incubation in MTT solution and 48 - 70 h formazan extraction. Max. score: 100.0. Reversibility: other: not applicable to the EPISKIN skin irritation assay. Remarks: Mean OD of replicate blanks has been accounted for by subtraction. (migrated information)
- Irritation / corrosion parameter:
- other: other: BYK-LP N 22655 treated "true" tissue viability as % of OD of negative controls
- Value:
- 93.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Following 15 ± 0.5 minutes exposure to BYK-LP N 22655, 42 ± 1 h incubation in fresh maintenance medium, 3 h incubation in MTT solution and 48 - 70 h formazan extraction. Reversibility: other: not applicable to the EPISKIN skin irritation assay. Remarks: Mean OD of replicate blanks has been accounted for by subtraction. . (migrated information)
- Irritation / corrosion parameter:
- other: other: Positive Control Tissue viability as % of OD of negative controls
- Value:
- 11.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: Following 15 ± 0.5 minutes exposure to 5% SDS, 42 ± 1 h incubation in fresh maintenance medium, 3 h incubation in MTT solution and 48 - 70 h formazan extraction. Reversibility: other: not applicable to the EPISKIN skin irritation assay. Remarks: Mean OD of replicate blanks has been accounted for by subtraction.. (migrated information)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437 of July 2013: Bovine Corneal Opacity and Permeability test method for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro test
- Strain:
- other: bovine eyes
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 750 µl of test substance, positive control solution (ethanol) or negative control solution (physiol. saline) was introduced into the anterior part of each cornea holder. Following application, turning of the holder into horizontal position and its slight rotation ensured uniform distribution of the test substance over the surface of the cornea.
- Duration of treatment / exposure:
- 10 min (± 30 sec.).
Each cornea holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath. Following incubation, the test substance, positive and negative controls were removed and the epithelial surface of the cornea washed, at least three times or until the wash medium (EMEM* with phenol red) was clear and there was no discolouration.
* EMEM, Eagles Minimal Essential Medium - Details on study design:
- Eyes were maintained and transported to the laboratory and isolated corneas stored in sufficient HBSS* containing 1% penicillin-streptomycin solution (10’000 IU/ml and 10 mg/ml, respectively) until being used. The eyes were used within 4 hours of slaughter. Each treatment group (test substance, negative/positive controls) comprised 3 corneas from bovine eyes. Each cornea surrounded by ca. 2 to 3 mm of sclera was mounted to a holder. Adequate exposure of the epithelial surface of the cornea to the test substance was provided. Opacity of the cornea was determined by measurement of light transmission through the centre of each mounted cornea using a calibrated opacitometer. Permeability of the cornea was determined by spectrophotometric measurement at 490 nm (OD490) of medium from the posterior compartment of the cornea holder after addition of 1 ml of sodium fluorescein solution (4 mg/ml) to the anterior compartment, thus determining the degree of penetration of sodium fluorescein through all corneal cell layers. Prior to the spectrophotometric measurement, incubation with fluorescein solution had happened in horizontal position of the cornea holder at 32°C ± 1°C for 90 ± 5 minutes in a water bath. Then the medium in the posterior compartment was mixed by drawing approximately 2.5 ml gently up and down a 5 ml syringe, with a needle attached, three times. Any solution giving an OD490 value above 1.8 was diluted 1 in 5 with cMEM.
Effects to the cornea (corresponding to possible eye damage) were measured as opacity and permeability, which when combined gave an In Vitro Irritancy Score (IVIS) for each treatment group. A substance that induces an IVIS greater than 55 is defined as a corrosive or severe irritant.
*HBSS Hanks Balanced Salt Solution containing Ca++ and Mg++ without phenol red - Irritation parameter:
- other: in vitro irritancy score (IVIS)
- Basis:
- mean
- Remarks:
- calculated from the IVIS of each of 3 isolated bovine corneas
- Score:
- 0.5
- Remarks on result:
- other: IVIS = Corrected Opacity Value + (15 x Corrected permeability OD490 Value)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In both in vitro tests for skin irritation and eye irritation no irritating effects were observed. Therefore, classification of WS400136 for skin and eye irritation is not required [Regulation (EC) 1272/2008].
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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