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EC number: 302-080-5 | CAS number: 94088-77-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyltris(dimethylaminato)phosphorus(1+) tetrafluoroborate(1-)
- EC Number:
- 302-080-5
- EC Name:
- Benzyltris(dimethylaminato)phosphorus(1+) tetrafluoroborate(1-)
- Cas Number:
- 94088-77-4
- Molecular formula:
- C13H25BF4N3P
- IUPAC Name:
- benzyltris(dimethylamino)phosphanium; tetrafluoroboranuide
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been 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 representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratisla-va.
Designation of the kit: EPI-200-SIT
Day of delivery: 06. Sep. 2016
Batch no.: 23353 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25.1 mg, 24.8 mg, 24.9 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS buffer
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL 5% SDS-solution - Duration of treatment / exposure:
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates are trans-ferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL).
Then, the tissues were set in the incubator for 23 hours and 29 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2. - Duration of post-treatment incubation (if applicable):
- The tissues were removed from the incubator and shaken for 5 minutes (120 rpm). After that, 0.9 mL assay medium were filled in the lower row of the 6-well-plate Then the inserts were transferred into the lower row of the 6-well-plate and set into the incubator for 19 hours and 25 minutes for post-incubation at 37 ± 1°C and 5.0 ± 0.5% CO2.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Optical Density (Mean absorbance values)
- Run / experiment:
- 1-3
- Value:
- 1.68
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Measured Values
As blank, the optical density of isopropanol was measured in 8 wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table9.1‑a Absorbance values blank isopropanol (OD 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.047 |
0.043 |
0.043 |
0.042 |
0.040 |
0.039 |
0.040 |
0.037 |
0.041 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table9.1‑b Absorbance Values negative control, test item and positive control (OD 570 nm)
Designation |
Measurement |
Negative Control |
Tecnoflon BA 104 |
Positive Control |
Tissue 1 |
1 |
2.078 |
1.656 |
0.115 |
2 |
2.040 |
1.668 |
0.112 |
|
Tissue 2 |
1 |
2.082 |
1.681 |
0.111 |
2 |
2.091 |
1.678 |
0.112 |
|
Tissue 3 |
1 |
2.013 |
1.838 |
0.121 |
2 |
2.039 |
1.804 |
0.118 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol as given in table 9.1-a. The mean of the three tissues was also calculated.
Table9.1‑c Mean Absorbance Values
Designation |
Negative Control |
Tecnoflon BA 104 |
Positive Control |
Mean – blank (tissue 1) |
2.018 |
1.621 |
0.073 |
Mean – blank (tissue 2) |
2.046 |
1.639 |
0.071 |
Mean – blank (tissue 3) |
1.985 |
1.780 |
0.079 |
Mean of the three tissues |
2.016 |
1.680 |
0.074 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Three tissues of the human skin model EpiDermTM were treated with Tecnoflon BA 104 for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control, 5% SDS solution was used as positive con-trol.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.7% (required: < 20%).
Variation within the tissue replicates was acceptable (required: ≤ 18%).
After the treatment with the test item, the relative absorbance values were reduced to 83.3 %. This value is above the threshold for skin irritation potential (50%).
Therefore, Tecnoflon BA 104 is considered as non-irritant to skin in the Reconstructed Human Epidermis (RhE) Test Method. - Executive summary:
The test item is considered as non-irritant to skin.
After the treatment, the relative absorbance values were reduced to 83.3%. This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.
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