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EC number: 266-037-1 | CAS number: 65997-01-5
- 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:
- supporting study
- Study period:
- 3 August 2011 to 5 August 2011
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tall oil, sodium salt
- EC Number:
- 266-037-1
- EC Name:
- Tall oil, sodium salt
- Cas Number:
- 65997-01-5
- Molecular formula:
- Not applicable. UVCB substance.
- IUPAC Name:
- Alkaline Aqueous Extraction of sodium salts of fatty acids and rosin acids from the Kraft Pulping Process
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no further treatment occurred.
- Preliminary purification step: n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a
OTHER SPECIFICS:
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added: n/a
- other information:
In vitro test system
- Test system:
- human skin model
- Remarks:
- Epiderm
- Source species:
- human
- Details on animal used as source of test system:
- EpiDerm Skin Model
Supplier: MatTek Corporation, Ashland, MA, USA
Date received: 3rd of August 2011
Lot number of the tissue: 15168
Lot number of the assay medium: 072811TTA - Justification for test system used:
- N/a
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): 15168
- Production date: not specified
- Shipping date: not specified
- Delivery date: Received 3rd of August 2011
- Date of initiation of testing: 3rd of August 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: one time, unknown volume.
- Observable damage in the tissue due to washing: not specified
- Modifications to validated SOP: not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 5.0 mg/ml
- Incubation time: 3 hours
- Spectrophotometer: yes
- Wavelength: 540 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes, viable
- Barrier function: not specified
- Morphology: not specified
- Contamination: not specified
- Reproducibility: not specified
NUMBER OF REPLICATE TISSUES: Duplicate tissues used in 3-minute and 60-minute exposure. Duplicate negative and positive control tissues were also used.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues : Freeze-killed tissue were used for the MTT viability assay
- Procedure used to prepare the killed tissues: untreated EpiDerm tissues were placed in a freezer (-14 to -30°C) at least overnight
- No of replicates: Duplicate
- Method of calculation used: the relative mean viability was the mean obtained OD540 of the test item divided by the obtained mean of OD540 of the negative control and multiplied by 100.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Two
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability is ≥50 % after 3 minutes exposure and ≥15 % after 60 minutes exposure. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL of test item
NEGATIVE CONTROL
- Sterile distilled water
POSITIVE CONTROL
- 8 N potassium hydroxide - Duration of treatment / exposure:
- 3 and 60 minutes respectively
- Duration of post-treatment incubation (if applicable):
- Straight after exposure period, the tissues were rinsed and incucated for 3 hours during the MTT assay
- Number of replicates:
- duplicate cultures
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 101.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 55.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: yes
- Colour interference with MTT: not specified
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: n/a
Any other information on results incl. tables
Direct MTT Reduction:
The MTT solution containing the test item turned purple which indicated that the test item directly reduced MTT and therefore, the MTT viability assay was performed in parallel on viable and freeze-killed tissues.
Test item, positive control item and negative control item:
The mean OD540 values for the negative control, test item and positive control for the 3-Minute exposure period are given in Table 1 and for the 60-Minute exposure period in Table 2. The mean viabilities of the test item and positive control, relative to the corresponding negative control (i.e. same exposure time) are also given in each corresponding Table.
The relative mean viability of the test item treated tissues was 101.9% after the 3-Minute exposure period and 55.9% after the 60-Minute exposure period.
Quality criteria:
The mean OD540 of the two negative control tissues were 1.564 for the 3-Minute exposure period and 1.604 for the 60-Minute exposure period. These both met the test acceptance criteria.
A 3-Minute exposure period of 8.0 N Potassium Hydroxide revealed a mean relative tissue viability of 20.7%. The positive control acceptance criterion was therefore satisfied.
Table 1 - Mean OD540 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item (3-Minute exposure period)
Treatment |
OD540 of individual tissues |
Mean OD540 of duplicate tissues (tvt) |
Mean OD540 of tissues corrected for MIT direct reduction tkt-ukt |
Relative Mean Viability % |
Negative Contr019 |
1.621 |
1.564 |
na |
100* |
1.506 |
||||
Positive Controlo |
0.358 |
0.324 |
na |
20.7 |
0.289 |
||||
Test Item |
1.641 |
1.662 |
1.593 |
101.9 |
Corrected viability of treated killed tissues 0.152 (tkt) - 0.083 (ukt) = 0.069
Table 2 - Mean OD540 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item (60-Minute Exposure Period
Treatment |
|
OD540 of individual tissues |
Mean OD540 of duplicate tissues (tvt) |
Mean OD540 of tissues corrected for MTT direct reduction tkt-ukt |
Relative Mean Viability % |
Negative ControlC |
|
1.609 |
1.604 |
na |
|
|
1 598 |
||||
Positive ControlC |
|
0.199 |
0.169 |
na |
10.5 |
|
0.139 |
||||
Test Item |
|
0.907 |
1.066 |
0.896 |
55.9 |
Corrected viability of treated killed tissues 0.313 (tkt) - 0.143 (ukt) = 0.170
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro skin corrosion study using Epiderm Human Skin Models, conducted according to OECD Test Guideline 431 and in compliance with GLP, it was concluded that TOS E is not corrice to skin.
- Executive summary:
In an in vitro skin corrosion study using Epiderm Human Skin Models, conducted according to OECD Test Guideline 431 and in compliance with GLP, it was concluded that TOS E is not corrosive to skin. This was based on obtained values of 101.9 % tissue viability following 3 minutes exposure and 55.9 % tissue viability following 60 minutes exposure. To be considered as non-corrosive, a cell viability of ≥ 50% is required following 3 minutes exposure and ≥15 % following 60 minutes exposure. The tested positive and negative controls were considered to be valid.
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