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EC number: 288-927-9 | CAS number: 85940-40-5
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 22, 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- EC Number:
- 288-927-9
- EC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Cas Number:
- 85940-40-5
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Test material form:
- liquid: viscous
- Details on test material:
- viscous liquid, UVCB
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ 200
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: commercially available kit (EpiDerm™ 200)
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- Based on the results of ECVAM (European Center for Validation of Alternative Methods) funded validation studies, it was concluded by the ECVAM Scientific Advisory Committee that the EpiDerm™ human epidermis model is suitable to be used for distinguishing between corrosive and non-corrosive chemicals (ECVAM: ESAC statement on the application of the EpidermTM human skin model for skin corrosivity testing of 14-15 Mar 2000) as well as between irritant and non-irritant chemicals (ECVAM: ESAC statement on the scientific validity of in-vitro tests for skin irritation testing of 5 Nov 2008).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ 200
- Tissue batch number(s): not specified
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 25 Sep 2012
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature or 1 h at 37 °C (corrosion test); 25 min at room temperature followed by 35 min at 37 °C (irritation test)
- Temperature of post-treatment incubation (if applicable): 42 h at 37 °C (irritation test)
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 1 washing step, volume not specified
- 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: 1 mg/mL assay medium
- Incubation time: 3 h
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm (OD570)
- Filter: no reference filter (not further specified)
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: not specified
- Barrier function: not specified
- Morphology: not specified
- Contamination: not specified
- Reproducibility: These historical control data demonstrate the reproducibility of results and robustness of the procedures.
NUMBER OF REPLICATE TISSUES: 2 (corrosion test); 3 (irritation test)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues (if applicable): Epi-200 tissue was killed by freezing at –20 °C
- N. of replicates: 1
- Method of calculation used: In case of direct reduction of MTT by the test substance, the OD570 values measured in the freeze-killed control tissues (KC) would be used to correct the mean OD570 of the testsubstance treated tissues (mean OD570 KC corrected). Since killed tissue might still have a residual enzyme activity that is able to produce some formazan net OD570 KC is calculated by subtracting the OD570 KC of the NC from the OD570 KC of the test substance. In case the net OD570 KC is greater than 0.1 it is subtracted from the respective mean OD570 to result in the mean OD570 KC corrected. The mean OD570 KC corrected represents the formazan production linked to the tissue viability and therefore indicates the cytotoxic potency of the test substance.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 (corrosion test); 2 (irritation test)
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 1 hour exposure is less than 15%.
- 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%.
- The test substance is considered to be irritating to skin if the viability is less than or equal to 50%.
- The test substance is considered to be non-irritating to skin if the viability is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- other: MTT-reduction control (De-ionized water or test substance (corrosion test); PBS or test substance (irritation test)
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL (corrosion test); 30 µL (irritation test)
- Concentration (if solution): undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL (corrosion test); 30 µL (irritation test)
- Concentration (if solution): not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL (corrosion test); 30 µL (irritation test)
- Concentration (if solution): 8 n (corrosion test); 5 % (irritation test) - Duration of treatment / exposure:
- Corrosion test: 3 min at room temperature or 1 h at 37 °C
Irritation test: 25 min at room temperature followed by 35 min at 37 °C - Duration of post-treatment incubation (if applicable):
- Irritation test: 42 hours post-incubation period at 37 °C
- Number of replicates:
- see above
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test, 3 min exposure
- Value:
- 113
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Corrosion test, 1 h exposure
- Value:
- 82
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Irritation test, 1st test run
- Value:
- 65
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Irritation test, 2nd test run
- Value:
- 99
- 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: not reported
- Direct-MTT reduction: The test substance was able to reduce MTT directly. Therefore an additional MTT reduction control (KC) was introduced (performed with the corrosion test and the 2nd test run of the irritation test). As the MTT-reduction control was used for calculation of the 1-hour exposure in the corrosion test, an influence of the test substance due to direct MTT reduction had to be excluded for the irritation test. Therefore a 2nd test run of the irritation test was performed with an additional MTT reduction control. The ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing used during the 2nd test run.
- Colour interference with MTT: not reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: Based on the historical data, a profound experience with the assay is assumed
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: see tables 4 and 5
Any other information on results incl. tables
Table 1: Results of the corrosion test
|
Exposure: 3 min |
Exposure: 1 hour |
|||||||
Test substance |
|
tissue 1 |
tissue 2 |
KC |
mean |
tissue 1 |
tissue 2 |
KC |
mean* |
NC |
mean OD570 |
1.902 |
1.691 |
0.254 |
1.797 |
2.253 |
2.118 |
0.250 |
2.185 |
viability [% of NC] |
105.9 |
94.1 |
- |
100 |
103.1 |
96.9 |
- |
100 |
|
Test substance |
mean OD570 |
2.041 |
2.010 |
0.335 |
2.025 |
1.943 |
1.950 |
0.412 |
1.785 |
viability [% of NC] |
113.6 |
111.9 |
- |
113 |
88.9 |
89.2 |
- |
82 |
|
PC |
mean OD570 |
0.185 |
0.277 |
- |
0.231 |
0.110 |
0.106 |
- |
0.108 |
viability [% of NC] |
10.3 |
15.4 |
- |
13 |
5.0 |
4.9 |
- |
5 |
* The mean for the test substance after 1 hour exposure is given after KC-correction.
The result of the KC did not indicate an increased MTT reduction at the exposure period of 3 minutes (difference to KC of NC is not greater than 0.1). Thus the KC was not used for viability calculation for this exposure time.
Table 2: Results of the irritation test - 1st test run
Test substance |
|
tissue 1 |
tissue 2 |
tissue 3 |
mean |
SD |
NC |
mean OD570 |
2.295 |
2.144 |
2.121 |
2.187 |
|
viability [% of NC] |
105.0 |
98.1 |
97.0 |
100 |
4.33 |
|
Test substance |
mean OD570 |
1.367 |
1.174 |
1.700 |
1.414 |
|
viability [% of NC] |
62.5 |
53.7 |
77.7 |
65 |
12.16 |
|
PC |
mean OD570 |
0.059 |
0.063 |
0.065 |
0.062 |
|
viability [% of NC] |
2.7 |
2.9 |
2.9 |
3 |
0.13 |
Table 3: Results of the irritation test - 2nd test run
Test substance |
|
tissue 1 |
tissue 2 |
tissue 3 |
KC |
mean |
SD |
NC |
mean OD570 |
2.404 |
2.415 |
2.401 |
0.057 |
2.407 |
|
viability [% of NC] |
99.9 |
100.3 |
99.8 |
- |
100 |
0.29 |
|
Test substance |
mean OD570 |
2.347 |
2.414 |
2.384 |
0.067 |
2.381 |
|
viability [% of NC] |
97.5 |
100.3 |
99.0 |
- |
99 |
1.38 |
|
PC |
mean OD570 |
0.096 |
0.090 |
0.105 |
- |
0.097 |
|
viability [% of NC] |
4.0 |
3.7 |
4.4 |
- |
4 |
0.32 |
The result of the KC did not indicate an increased MTT reduction (difference to KC of NC is not greater than 0.1). Thus the KC was not used for viability calculation.
Table 4: Historical control data - Corrosion test
Historical Range of NC |
|
||||
OD570 |
|||||
Exposure Time |
Historical Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Feb 2010 - Aug 2012 |
1.901 |
0.200 |
2.30 |
1.50 |
60 minutes |
Feb 2010 - Aug 2012 |
1.867 |
0.203 |
2.27 |
1.46 |
Historical Range of PC |
|
|
|
|
|
OD570 |
|
|
|
|
|
Exposure Time |
Historical Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Feb 2010 - Aug 2012 |
0.361 |
0.087 |
0.54 |
0.19 |
60 minutes |
Feb 2010 - Aug 2012 |
0.155 |
0.048 |
0.25 |
0.06 |
Viability (%) |
|
|
|
|
|
Exposure Time |
Historical Period |
Mean % |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Feb 2010 - Aug 2012 |
19.16 |
4.73 |
28.62 |
9.69 |
60 minutes |
Feb 2010 - Aug 2012 |
8.47 |
2.82 |
14.12 |
2.82 |
Table 5: Historical control data - Irritation test
Historical Range of NC |
|
|||
OD570 Historical Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
Feb 2010 - Nov 2012 |
2.060 |
0.281 |
2.62 |
1.50 |
Historical Range of PC |
|
|||
OD570 Historical Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
Feb 2010 - Nov 2012 |
0.111 |
0.052 |
0.22 |
0.01 |
Viability (%) |
|
|||
Historical Period |
Mean % |
SD |
Mean + 2 SD |
Mean - 2 SD |
Feb 2010 - Nov 2012 |
5.5 |
2.47 |
10.45 |
0.56 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that the test item does not show a skin irritation potential in the EpiDerm™ skin corrosion/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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