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EC number: 696-130-6 | CAS number: 1364681-45-7
- 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:
- From 25 Sep 2012 to 18 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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)
- Version / remarks:
- July 22, 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: B.46: In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test; Official Journal of the European Union, No. L 193
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- EC Number:
- 696-130-6
- Cas Number:
- 1364681-45-7
- Molecular formula:
- Unspecified
- IUPAC Name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Resin acids and rosin acids, reaction products with formaldehyde, calcium salts
- Physical state: Solid
- Analytical purity: 96.0 % w/w
- Lot/batch No.: DMG 7245
- Expiration date of the lot/batch: July 05, 2016
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
- Others:
pH-value: Ca. 5 (undiluted test substance, moistened with water)
Constituent 1
Test animals
- Species:
- other: in vitro test on three dimensional human epidermis model (EpiDerm™ model which consists of normal human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis.)
- Strain:
- other: not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable (in vitro test)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL bulk volume (about 5 mg) - Duration of treatment / exposure:
- 1 hour followed by a 42-hours post-incubation period
- Observation period:
- not applicable (in vitro test)
- Number of animals:
- not applicable (in vitro test)
- Details on study design:
- Test system:
- In vitro test system on three dimensional human epidermis models. The EpiDermTM model consists of normal, human-derived epidermal keratinocytes cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
- The test system is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed epidermis after a 1-hour topical exposure and about 42 hours postincubation.
Material and technical equipment:
- EpiDerm™ 200 kit: MatTek Corp., Bratislava, Slovakia containing 24 Epi-200 tissues (reconstructed epidermis): surface 0.6 cm² cultured in Millicells® diameter 1 cm.
Controls:
- Negative control (NC): 30 μL PBS, sterile
- Positive control (PC): 30 µL 5% (w/v) sodium dodecyl sulfate (SDS, Sigma, Germany) in deionized water, sterile
Experimental procedure:
- Direct MTT reduction:
To assess the ability of the test material to directly reduce MTT a pretest was performed. Thereby, the test substance was added to 0.9 mL of the MTT solution. A negative control (de-ionized water) was tested concurrently. If the MTT solution colour or, in case of water-insoluble test substances the border to the water-phase, turned blue / purple, the test substance was presumed to directly reduce MTT. The direct reduction of MTT by a test substance interferes with the colour density produced by metabolic capacity of the tissue and would falsify the test results.
- Basic procedure:
Three tissues were treated with the test substance, the PC and NC, respectively.
• 25 μL sterile PBS was applied first. Thereafter, a bulk volume of 25 μL of the solid test material was applied with a sharp spoon and homogeneously distributed together with the fluid.
• 1 hour after start of application of the test material to the stratum corneum surface of the EpiDermTM tissue, residual test material was removed with sterile PBS and the surface of each tissue was dried. Subsequently, the tissues were incubated at 37°C for 24 ± 2 hours, transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and thereafter placed into the incubator for additional 18 ± 2 hours post-incubation period.
• After the postincubation period induced tissue destruction (cytotoxicity = loss of viability) was determined by measuring the metabolic activity of the tissue using a colourimetric assay. Thereby, cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow coloured water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue coloured formazan. After isopropanol extraction of the formazan from the tissues, the optical densitiy of the extract is determined spectrophotometrically. Optical density of the extracts of test substance treated tissues is compared to negative control values and expressed as relative tissue viability.
Acceptance criteria:
In case one of the below given acceptance criteria is not covered, repetition of the test is considered.
- Assay acceptance criterion for the negative control (NC): The absolute OD570 of the negative control tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is ≥ 1.0. The mean OD570 of the NC should not exceed 2.5.
- Assay acceptance criterion for the positive control (PC): 5% SDS is used as PC and reflects the sensitivity of the tissues used in the test conditions. A viability of ≤ 20% is acceptable.
- Assay acceptance criterion for tissue variability: For every treatment, 3 tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the SD of %-viability is ≤ 20.
Evaluation criteria:
- Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: viability (%)
- Value:
- 102
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 1 h. Max. score: 102.7. Reversibility: other: not applicable. Remarks: In Vitro Skin Irritation. (migrated information)
In vivo
- Irritant / corrosive response data:
- 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%. - Other effects:
- No other effects observed.
Any other information on results incl. tables
Table 2: In Vitro Skin Irritation
Test substance |
Exposure: 1 hour |
|
|
|||
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
||
NC |
Mean OD570 |
2.295 |
2.144 |
2.121 |
2.187 |
|
Viability (% of NC) |
105.0 |
98.1 |
97.0 |
100 |
4.33 |
|
Test Substance |
Mean OD570 |
2.222 |
2.237 |
2.245 |
2.234 |
|
Viability (% of NC) |
101.6 |
102.3 |
102.7 |
102 |
0.54 |
|
PC |
Mean OD570 |
0.059 |
0.063 |
0.065 |
0.062 |
|
Viability (% of NC) |
2.7 |
2.9 |
2.9 |
3 |
0.13 |
NC: Negative control, PBS, sterile
PC: Positive control, 5% SDS in deionized water, sterile
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- CLP: not classified
DSD: not classified
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