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EC number: 212-216-4 | CAS number: 770-05-8
- 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:
- 26-06-2018 to 21-08-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride
- EC Number:
- 212-216-4
- EC Name:
- DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride
- Cas Number:
- 770-05-8
- Molecular formula:
- C8H11NO2.ClH
- IUPAC Name:
- 4-(2-amino-1-hydroxyethyl)phenol hydrochloride
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- Identification: Octopamine hydrochloride
Appearance: White to off white powder
Batch: D151-1710037
Purity/Composition: 99.8%
Test item storage: At room temperature protected from light
Stable under storage conditions until: 26 October 2019 (retest date)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Details on animal used as source of test system:
- Mattek corp: Human neonatal foreskin lot number 28831 keratinocyte strain number 00267
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm Skin Model (EPI-200, Lot no.: 28831, kit O&P,)
The 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:
- 28.7 to 33.8 mg of the solid test item was added into the 6-well plates on top of the
skin tissues. - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- N/A
- Number of replicates:
- Two tissues were used for a 3-minute exposure to Octopamine
hydrochloride and two for a 1-hour exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 94
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- ca. 60
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Octopamine hydrochloride 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 the test item did not interfere with the MTT endpoint.
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. The mean
relative tissue viability following the 1-hour exposure to the positive control was 7.4%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was
<=13%, indicating that the test system functioned properly.
Any other information on results incl. tables
The mean absorption at 570 nm measured after treatment with Octopamine hydrochloride and
controls are presented in Table 1.
Table 2 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with
Octopamine hydrochloride compared to the negative control tissues. Skin corrosion is
expressed as the remaining cell viability after exposure to the test item. The relative mean
tissue viability obtained after the 3-minute and 1-hour treatments with Octopamine
hydrochloride compared to the negative control tissues was 94% and 60% respectively.
Because the mean relative tissue viability for Octopamine hydrochloride was not below 50%
after 3 minutes treatment and not below 15% after 1 hour treatment Octopamine
hydrochloride is considered to be not corrosive.
Table 1
Mean Absorption in the in vitro Skin Corrosion Test with Octopamine hydrochloride
|
3 minute application |
1 hour application |
||||||
|
A(OD570) |
B(OD570) |
Mean OD570 |
SD |
A(OD570) |
B(OD570) |
Mean OD570 |
SD |
Negative Control |
1.724 |
1.762 |
1.743 |
0.027 |
1.814 |
1.715 |
1.765 |
0.070 |
Test Item |
1.745 |
1.518 |
1.632 |
0.160 |
1.095 |
1.021 |
1.058 |
0.052 |
Positive Control |
0.145 |
0.103 |
0.124 |
0.030 |
0.120 |
0.139 |
0.130 |
0.014 |
Table 2: mean Tissue Viability in the in vitro Skin corrosion test with Octopamine hydrochloride
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
|
Negative control |
100 |
100 |
Octopamine hydrochloride |
94 |
60 |
Positive control |
7.1 |
7.4 |
Table 3: Coefficient of Variation between Tissue Replicates
3 minute | 1 hour | |
Negative Control | 2.1 | 5.5 |
Octopamine hydrochloride | 13 | 6.8 |
Positive control | 29 | 14 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, Octopamine hydrochloride 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 Octopamine hydrochloride for its ability to induce
skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The
possible corrosive potential of Octopamine hydrochloride 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 D151-1710037 of Octopamine hydrochloride was a white to off white powder. Skin
tissue was moistened with 25 µL of Milli-Q water and at least 25 mg of Octopamine
hydrochloride was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 7.4% 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 <=13%, indicating that the
test system functioned properly.
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 Octopamine
hydrochloride compared to the negative control tissues was 94% and 60%, respectively.
Because the mean relative tissue viability for Octopamine hydrochloride was not below 50%
after the 3-minute treatment and not below 15% after the 1-hour treatment Octopamine
hydrochloride is considered to be not corrosive.
In conclusion, Octopamine hydrochloride is not corrosive in the in vitro skin corrosion test
under the experimental conditions described in this report.
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