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EC number: 269-142-0 | CAS number: 68188-14-7
- 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:
- Feb - Apr 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, barium salts
- EC Number:
- 269-142-0
- EC Name:
- Resin acids and Rosin acids, barium salts
- Cas Number:
- 68188-14-7
- Molecular formula:
- N/A
- IUPAC Name:
- Resin acids and Rosin acids, barium salts
- Test material form:
- solid
- Details on test material:
- Specific details on test material used for the study
SOURCE OF TEST MATERIAL
- Batch number of test material: EXP NR.3757-01
- Expiration date of the lot/batch: 31 Dec 2029
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under storage conditions: The stability of the test substance under storage conditions is
guaranteed until 31 Dec 2029 as indicated by the sponsor, and the sponsor holds this responsibility.
- Stability under test conditions: no data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: BASF SE, Ludwigshafen Germany
- lot/batch number of test material: EXP NR.3757-01
- Expiration date: 31 Dec 2029
- Purity: 100 % UVCB
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Stability under storage conditions: The stability was guaranteed over the study period
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi 200
- Tissue batch number(s): 30854
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C, 1 hour
- Post-incubation temperature and time: 37°C, 18 ± 2 hours
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: yes
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL MTT diluent
- Incubation time: 3 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
- Filter: without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD570, accetable
- Barrier function: Lower acceptance limit: ET50 = 4.0 hours, Upper acceptance limit: ET50 = 8.7 hours
- Contamination: no
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- freeze-killed tissues
- Procedure used to prepare the killed tissues: freezing
- N. of replicates : 3
- Method of calculation used: The individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of three tissues treated in the same way is calculated.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the mean tissue viability after exposure is less than 50%.
- The test substance is considered to be borderline irritant (inconclusive) to skin if the mean tissue viability after exposure is 45-55%.
- The test substance is considered to be non-irritant to skin if the viability after exposure is greater than or equal to 50%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: The “borderline“ evaluation (50 ± 5%) was statistically determined by using historic BASF data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 439. - Control samples:
- yes, concurrent negative control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg per tissue
- Concentration (if solution):
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 25 minutes at room temperature and 35 minutes in the incubator
- Duration of post-treatment incubation (if applicable):
- ca. 42
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1
- Value:
- 104.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 99.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3
- Value:
- 96.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
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
Any other information on results incl. tables
Table 1: Individual and mean OD570 values, individual and mean viability values, standard deviations
and coefficient of variation
Test substance identification |
|
|
tissue 1 |
tissue 2 |
tissue 3 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.118 |
2.093 |
2.054 |
2.088 |
||
viability [% of NC] |
101.4 |
100.2 |
98.3 |
100.0 |
1.5 |
1.5 |
||
KC tissues |
mean OD570 |
0.059 |
0.072 |
0.054 |
0.061 |
|||
viability [% of NC] |
2.8 |
3.4 |
2.6 |
2.9 |
0.4 |
15.2 |
||
Barium resinate |
viable tissues |
mean OD570 |
2.189 |
2.085 |
2.008 |
2.094 |
||
viability [% of NC] |
104.8 |
99.8 |
96.1 |
100.3 |
4.4 |
4.3 |
||
KC tissues* |
mean OD570KC NC corrected |
0.000 |
0.000 |
0.000 |
0.000 |
|||
viability [% of NC] |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
||
Final mean viability of tissues after KC correction [% of NC]: |
100.3 |
|||||||
PC |
viable tissues |
mean OD570 |
0.043 |
0.043 |
0.049 |
0.045 |
||
viability [% of NC] |
2.1 |
2.0 |
2.3 |
2.1 |
0.2 |
8.1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria described, it was concluded that the test substance does not show a skin irritation potential in the EpiDermTM in vitro skin irritation test under the test conditions chosen.
- Executive summary:
The potential of the test substance to cause dermal irritation was assessed by a topical application of ca. 2 x 25 µL bulk volume of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™). Due to the chemical and physical properties of the test substance, a double bulk volume (corresponding to ca. 10 mg per tissue) was required for covering the whole tissue surface.
Three EpiDerm™ tissues were incubated with the test substance for 1 hour followed by a 42-hour post-incubation period. In addition to the test substance, 30 µL per tissue of a negative control (PBS) and of a positive control (5% SDS) were applied to three tissues each.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
The following results were obtained in the EpiDerm skin irritation test:
The test substance is able to reduce MTT directly. Therefore, an additional MTT reduction control KC (freeze-killed control tissues) was introduced. The final relative mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubation was 100.3%. The acceptance criteria for the variability of the tissues are met. Application of the positive control 5% SDS showed a relative mean viability of the tissues of 2.1% and reflects the expected sensitivity of the tissues. The mean OD570 of the negative control (PBS) fulfills the acceptance criteria and demonstrates the validity of the assay.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test substance does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation test under the test conditions chosen.
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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