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EC number: 291-909-3 | CAS number: 90506-47-1
- 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:
- 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:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- EC Number:
- 291-909-3
- EC Name:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- Cas Number:
- 90506-47-1
- Molecular formula:
- complex substance
- IUPAC Name:
- Phosphoric acid, C8-16-alkyl esters, reaction products with (Z)-N-9-octadecenyl-1,3-propanediamine
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 80555E094
- Expiration date of the lot/batch: 05/12/2018
- Purity test date: 23/01/2018
- Date of receipt: 22/02/2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient
In vitro test system
- Test system:
- human skin model
- Justification for test system used:
- The EpiDerm(TM) Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The test was carried out with the reconstituted three-dimensional human skin model EpiDerm(TM) (MatTek).
- Tissue batch number: 25882
- Date of initiation of testing: 22/02/2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: incubated at 37 ± 1°C,
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Using a wash bottle, the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
- Observable damage in the tissue due to washing: no damage reported.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution: 5 mg/mL MTT (Sigma; Lot MKBZ5197V) in PBS (Gibco; Lot No.: 1909266, 1877596). MTT medium: MTT stock solution was diluted 1 + 4 with DMEM-based medium (final concentration 1 mg/mL).
- Incubation time: 3h
- Spectrophotometer used
- Wavelength: OD was measured at 570 nm
NUMBER OF REPLICATE TISSUES: 4
CONTROLS
- Negative control: Distilled water (Aqua dest.; Lot: RNBG3519, Sigma) ; 50µL applied
- Positive control: 8 N Potassium Hydroxide (KOH; CAS No.: 1310-58-3; Lot: 10357-004, NeoLab) ; 50 µL applied
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues used
- Procedure used to prepare the killed tissues: two tissues per treatment period were treated with the test item (KT) or left untreated (KU), respectively.
- N. of replicates: 2
- Method of calculation used:
NSMTT (non-specific reduction of MTT) was calculated relative to the negative control of living tissues (NK) per treatment period according to the following formula: NSMTT = [(ODKT - ODKU)/ODNK] * 100
The true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) was corrected for each treatment period according to the following formula: TODTT = ODTM - (ODKT - ODKU)
PREDICTION MODEL / DECISION CRITERIA
The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied undiluted. 50 μL of the test item were dispensed directly atop the EpiDerm(TM) tissue. The test item was spread to match size of the tissue.
Negative control: 50 μL of distilled water
Positive control: 50 μL of 8 N KOH - Duration of treatment / exposure:
- 2 treatment period: 3 min and 60 min exposure time.
- Duration of post-treatment incubation (if applicable):
- The plate was incubated for 3 h at 37 ± 1°C, 5.0% CO2 / 95% air.
- Number of replicates:
- The test was performed on a total of 4 replicates tissues, 2 replicates for each treatment period (3 min and 60 min exposure time).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3min exposure
- Value:
- 96.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: NSMTT-corrected
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60min exposure
- Value:
- 94.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: NSMTT-corrected
Any other information on results incl. tables
Results of 3 min Experiment:
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.730 |
1.801 |
1.689 |
1.761 |
0.193 |
0.300 |
1.702 |
1.800 |
1.763 |
1.784 |
0.203 |
0.278 |
|
1.784 |
1.800 |
1.796 |
1.771 |
0.227 |
0.287 |
|
OD570- Blank Corrected |
1.685 |
1.756 |
1.644 |
1.716 |
0.148 |
0.255 |
1.657 |
1.755 |
1.718 |
1.739 |
0.158 |
0.233 |
|
1.739 |
1.755 |
1.751 |
1.726 |
0.182 |
0.242 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.694 |
1.755 |
1.705 |
1.727 |
0.163 |
0.243 |
SD OD570 of 3 Aliquots |
0.042 |
0.001 |
0.055 |
0.012 |
0.017 |
0.011 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.724* |
1.716 |
0.203 |
|||
TODTT |
- |
1.659 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.043 |
0.016 |
0.057 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
99.5 |
11.8 |
|||
Mean Relative Tissue Viability [%] - NSMTT Corrected |
- |
96.2 |
- |
|||
Coefficient Of Variation [%]*** |
2.5 |
0.9 |
28.0 |
* corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is≤30%.
Results of NSMTT control of 3 min Experiment:
NSMTT |
KU |
KT |
Negative Control |
|||
Tissue |
1 2 |
1 2 |
1 |
2 |
||
absolute OD570 -values |
0.267 |
0.227 |
0.282 |
0.321 |
1.730 |
1.801 |
0.267 |
0.229 |
0.290 |
0.319 |
1.702 |
1.800 |
|
0.268 |
0.225 |
0.291 |
0.323 |
1.784 |
1.800 |
|
OD570(Blank Corrected) |
0.222 |
0.182 |
0.237 |
0.276 |
1.685 |
1.756 |
0.222 |
0.184 |
0.245 |
0.274 |
1.657 |
1.755 |
|
0.223 |
0.180 |
0.246 |
0.278 |
1.739 |
1.755 |
|
mean OD570 (mean of 3 aliquots) |
0.222 |
0.182 |
0.243 |
0.276 |
1.694 |
1.755 |
total mean OD570 (mean of the replicate tissues) |
0.202 |
0.260 |
1.724 |
|||
SD OD570(of the replicate tissues) |
0.029 |
0.023 |
0.043 |
|||
NSMTT [%] |
3.3 |
- |
||||
Relative Tissue Viability [%] |
- |
98.2 |
101.8 |
|||
Mean Relative Tissue Viability [%] |
- |
100.0 |
||||
SD Tissue Viability [%] |
- |
2.5 |
||||
CV [% Viabilities] |
- |
2.5 |
Results of 60 min Experiment:
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.763 |
2.027 |
1.779 |
1.901 |
0.096 |
0.176 |
1.786 |
2.030 |
1.840 |
1.889 |
0.099 |
0.182 |
|
1.793 |
2.003 |
1.841 |
1.912 |
0.102 |
0.181 |
|
OD570- Blank Corrected |
1.718 |
1.982 |
1.734 |
1.856 |
0.051 |
0.131 |
1.741 |
1.985 |
1.795 |
1.844 |
0.054 |
0.137 |
|
1.748 |
1.958 |
1.796 |
1.867 |
0.057 |
0.136 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.736 |
1.975 |
1.775 |
1.856 |
0.054 |
0.135 |
SD OD570 of 3 Aliquots |
0.016 |
0.015 |
0.036 |
0.011 |
0.003 |
0.003 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.856* |
1.815 |
0.094 |
|||
TODTT |
- |
1.746 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.169 |
0.057 |
0.057 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
97.8 |
5.1** |
|||
Mean Relative Tissue Viability [%] - NSMTT Corrected |
- |
94.1 |
- |
|||
Coefficient Of Variation [%]*** |
9.1 |
3.1 |
60.3 |
* corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
**mean relative tissue viability of the 60 min positive control < 15%
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is≤30%.
Results of NSMTT control of 60 min Experiment:
NSMTT |
KU |
KT |
Negative Control |
|||
Tissue |
1 2 |
1 2 |
1 |
2 |
||
absolute OD570 -values |
0.217 |
0.279 |
0.271 |
0.368 |
1.763 |
2.027 |
0.222 |
0.280 |
0.272 |
0.359 |
1.786 |
2.030 |
|
0.224 |
0.282 |
0.271 |
0.375 |
1.793 |
2.003 |
|
OD570(Blank Corrected) |
0.172 |
0.234 |
0.226 |
0.323 |
1.718 |
1.982 |
0.177 |
0.235 |
0.227 |
0.314 |
1.741 |
1.985 |
|
0.179 |
0.237 |
0.226 |
0.330 |
1.748 |
1.958 |
|
mean OD570 (mean of the aliquots) |
0.176 |
0.235 |
0.226 |
0.322 |
1.736 |
1.975 |
total mean OD570 (mean of the replicate tissues) |
0.206 |
0.274 |
1.856 |
|||
SD OD570(of the replicate tissues) |
0.042 |
0.068 |
0.169 |
|||
NSMTT [%] |
3.7 |
- |
||||
Relative Tissue Viability [%] |
- |
100.7 |
114.6 |
|||
Mean Relative Tissue Viability [%] |
- |
107.6 |
||||
SD Tissue Viability [%] |
- |
9.8 |
||||
CV [% Viabilities] |
- |
9.1 |
Test acceptance criteria:
|
Value |
Cut off |
pass/fail |
Mean Absolute OD570 nmNK (3 min Experiment) |
1.769 |
0.8 ≤ NK ≤ 2.8 |
pass |
Mean Absolute OD570 nmNK (60 min Experiment) |
1.900 |
0.8 ≤ NK ≤ 2.8 |
pass |
Mean Relative Tissue Viability [%] of PC (60 min experiment) |
5.1 |
< 15% |
pass |
CV [%](in the range of 20 – 100% viability) |
0.9 – 9.1 |
≤ 30% |
pass |
Historical data:
|
Mean |
SD |
n |
OD570of NK (3 min Experiment) |
1.895 |
0.313 |
10 |
OD570of NK (60 min Experiment) |
1.867 |
0.261 |
11 |
Relative Tissue Viability [%] of PC (60 min experiment) |
6.1 |
1.99 |
11 |
CV [%](in the range of 20 – 100% viability) |
7.3 |
6.6 |
31 |
Historical control data were generated from 2015 - 2016.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In the present study the skin corrosivity potential of ARCOT 3135/384 was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm™, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was≥50% (96.2%, NSMTT-corrected) after 3 min treatment and≥15% (94.1%, NSMTT-corrected) after 60 min treatment.
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