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EC number: 268-859-6 | CAS number: 68152-93-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2017-August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tall oil, maleated
- EC Number:
- 268-859-6
- EC Name:
- Tall oil, maleated
- Cas Number:
- 68152-93-2
- Molecular formula:
- UVCB
- IUPAC Name:
- 3,7-dimethyl-14,16-dioxo-19-(propan-2-yl)-15-oxapentacyclo[10.5.2.0²,¹¹.0³,⁸.0¹³,¹⁷]nonadeca-13(17),18-diene-7-carboxylic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid
- Test material form:
- liquid
- Details on test material:
- Lot No.: HD0258QH13
Constituent 1
- Specific details on test material used for the study:
- Viscous brown liquid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cells purchased or derived from tissues obtained by accredited institutions from donor
- Source strain:
- other: 00267
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC)
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The liquid test item was applied undiluted (50 μl) directly on top of the tissue.
- Details on test system:
- EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, 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 EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µl undiluted test item was added into the 6-well plates on top of the skin tissues.
For the negative and positive controls, 2 tissues were treated with 50 μl Milli-Q water (negative control) and 2 tissues were treated with 50 μl 8N KOH (positive control) for both the 3-minute and 1-hour time point. - Duration of treatment / exposure:
- 3 min and 1 hour treatment
- Number of replicates:
- 2 replicates for test item per each exposure time (3 minutes/1 hour)
2 replicates for the positive control per each exposure time (3 minutes/1 hour)
2 replicates for the negative control per each exposure time (3 minutes/1 hour)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 Minute application (first test)
- Value:
- 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Since the individual values for the 3-minute exposure were above and below the 50% (71 and 49% respectively) and the Coefficient of Variation was above 30%, the test was inconclusive and a repeat experiment for the 3-minute exposure was performed.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute application (second test)
- Value:
- 79
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour application
- Value:
- 90
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- EnvaMul 600 was checked for color interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that EnvaMul 600 did not interfere with the MTT endpoint.
Any other information on results incl. tables
Mean Tissue Viability in the in vitro Skin Corrosion Test with EnvaMul 600
First test
3-minute application viability (percentage of control)
Negative control 100
EnvaMul 600 60
Positive control 7.4
Second test
3-minute application viability (percentage of control)
Negative control 100
EnvaMul 600 79
Positive control 9.2
1-hour application viability (percentage of control)
Negative control 100
EnvaMul 600 90
Positive control 5.3
Coefficient of Variation between Tissue Replicates
First test- 3 minute
Negative control 5.1
EnvaMul 600 31
Positive control 26
Second test- 3 minute
Negative control 10
EnvaMul 600 30
Positive control 7.9
1 hour
Negative control 6.8
EnvaMul 600 1.9
Positive control 9.2
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- EnvaMul 600 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
The objective of this study was to evaluate EnvaMul 600 for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)).
The possible corrosive potential of EnvaMul 600 was tested through topical application for 3 minutes and 1 hour. The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch HD0379UD11 of EnvaMul 600 was a viscous brown liquid. EnvaMul 600 was applied undiluted (50 μl) directly on top of the skin tissue. The positive control had a mean relative tissue viability of 5.3% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was <7% for the negative control and 31% for the test item. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with EnvaMul 600 compared to the negative control tissues was 60% and 90%, respectively. However, since the individual values for the 3-minute exposure were above and below the 50% (71 and 49% respectively) and the Coefficient of Variation was above 30%, this part of the test was inconclusive and a repeat experiment for the 3-minute exposure was performed.
In the second test, the positive control had a mean relative tissue viability of 9.2% after the 3-minute exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 30%. The relative mean tissue viability obtained after 3-minute treatment with EnvaMul 600 compared to the negative control tissues was 79%. Because the mean relative tissue viability for EnvaMul 600 was not below 50% after the 3-minute treatment in the second experiment and not below 15% after the 1-hour treatment in the first experiment, EnvaMul 600 is considered to be not corrosive. In conclusion, EnvaMul 600 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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