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EC number: 264-267-7 | CAS number: 63484-12-8
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation.
Key study. Method according to OECD 439, GLP study. The mean corrected percent viability of the SkinEthic™ RHE treated tissues was 71.8 %, versus 2.9% in the positive control. Therefore, the test item is not irritant to the skin.
Eye irritation.
Weight of evidence: Method according to OECD 438, GLP study. No prediction can be made, since the combinations of the 3 endpoints for the test item were 2 x II, 1 x I.
Weight of evidence: Method according to OECD 437, GLP study. The mean IVIS score for the test item was found to be 0, while the value for the positive control was 163.Therefore, the test item has been identified as not irritant to eye, not requiring classification for eye irritation or serious eye damage.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- Reconstructed Human Epidermis Test Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 19,2016 - November 4, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:room temperature - Test system:
- human skin model
- Remarks:
- SkinEthic RHE® model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Justification for test system used:
- The SkinEthic™ RHE model has been validated for irritation testing (Validation study based on the original ECVAM Performance Standards (21) in 2008) and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was applied as supplied
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:SkinEthic RHE® model
- Tissue batch number(s): 16-RHE-114
- Delivery date: 02 November 2016
Expiration date: November 7, 2016
- Date of initiation of testing: 02 November 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:25 x 1 mL of DPBS
- 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: 300 μL of a MTT solution at 1.0 mg/mL
- Incubation time: 2h 58 minutes
- Spectrophotometer: ELx800 absorbance microplate reader (BioTek)
- Wavelength:570 nm
- Linear OD range of spectrophotometer: The linearity range of optical density measured is validated for an optical density between 0 and 2.0.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: tissue batch: O.D.= 1.2 (CV = 1.3%) specification OD>0.7
Historical control data: mean O.D. range = 0.459 - 1.243
- Barrier function:4.2 h SPECIFICATION 4.0h< ET50<10H
- Morphology: 5 Cell layers, absence of significant histological abnormalities, well differentiated epidermis, specification > 4
- Contamination:no
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: no interference.
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 viability after 42 minutes exposure is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 42 minutes exposure is greater than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg of test item (32mg/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours and 30 minutes
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- ca. 71.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The mean corrected percent viability of the treated tissues was 71.8 %, versus 2.9% in the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item is not irritant to the skin.
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: A yellow non-homogenous suspension was observed after 3 hours of incubation between 36.9°C and 37.8°C, 5% CO2. Therefore, there is no direct interaction between the test item and MTT.
- Colour interference with MTT:
In water: A white non-homogenous suspension was obtained after 3 hours of incubation between 37.1°C and 37.8°C, 5% CO2.
In isopropanol: A white non-homogenous suspension was obtained after 2 hours of incubation at room temperature. Therefore the test item will not interfere with the MTT assay and there is no need to add nonspecific coloration controls to the study.
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes, A full demonstration of proficiency was performed for the EpiSkin-SM model, plus a reduced validation with the SkinEthic RHE model. Adequate results were obtained for the evaluated chemicals. Summary of proficiency chemicals testing according to OECD 439 criteria included in the report.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the standard deviation of the negative control group was 8.5%, the acceptablility criteria is SD ≤ 18%, OD mean of negative control is 1.185 and the acceptability criteria is OD >0.6 x<1.5
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean corrected percent viability of the treated tissues was 71.8 %, versus 2.9% in the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item is not irritant to the skin.
- Executive summary:
The aim of the study was to evaluate the possible irritating effects of the test item after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model). This test was performed according to OECD TG 439 (GLP study). The test item was applied at the dose of 16 mg, to 3 living Reconstructed Human epidermis during 42 minutes, followed by a rinse with 25 mL of DPBS and a 42 hours and 30 minutes post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.The mean corrected percent viability of the treated tissues was 71.8%, versus 2.9 % in the positive control (5% Sodium Dodecyl Sulfate). The test item has to be considered as Non-irritant to skin, corresponding to UN GHS No Category.
Reference
Table 1: Summary of results:
|
SKIN |
OD |
Mean OD/disc |
Mean OD/product |
Viability % |
Mean viability % |
SD |
CRITERIA |
Negative control |
1 |
1.091 |
1.135 |
1.185 |
95.8 |
100.00 |
8.5 |
|
1.301 |
||||||||
1.118 |
||||||||
2 |
1.292 |
1.301 |
109.8 |
|||||
1.325 |
||||||||
1.285 |
||||||||
3 |
1.135 |
1.118 |
94.4 |
|||||
1094 |
||||||||
1.125 |
||||||||
Positive control |
4 |
0.034 |
0.034 |
0.035 |
2.9 |
2.9 |
0.1 |
Irritant |
0.035 |
||||||||
0.034 |
||||||||
5 |
0.038 |
0.036 |
3.0 |
|||||
0.036 |
||||||||
0.034 |
||||||||
6 |
0.036 |
0.034 |
2.9 |
|||||
0.034 |
||||||||
0.031 |
||||||||
Test item PH-15/0504 |
7 |
0.806 |
0.801 |
0.850 |
67.6 |
71.8 |
3.8 |
Non irritant |
0.792 |
||||||||
0.805 |
||||||||
8 |
0.878 |
0.859 |
72.5 |
|||||
0.811 |
||||||||
0.889 |
||||||||
9 |
0.923 |
0.890 |
75.1 |
|||||
0.886 |
||||||||
0.860 |
The results were expressed as a viability percentage compared with the negative control
validity %= (ODtest item/ OD negative control )*100
The OD values obtained for each test sample were used to calculate a percentage of viability relative
to the negative control, which was arbitrarily set at 100%.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 15, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: yes - Species:
- cattle
- Strain:
- other: Bos taurus (bovine cattle)
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: freshly slaughtered cattle at the abattoir EVA, Saint Pierre sur Dives, France.
- Characteristics of donor animals: up to 12 months old, typically, 5 to 8 months old (French Authorities avoid the use of any organs from the head of bovines aged more than 12 months).
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Transported at ambient temperature, immerged in buffered Hanks medium containing an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)]. A container with smooth internal surfaces was used for the transport to avoid damage to the corneas.
- Time interval prior to initiating testing: Upon arrival to the laboratory, preparation and selection was performed immediately. The corneas were used within a maximum of 24 hours.
- indication of any existing defects or lesions in ocular tissue samples: No - A macroscopic examination was performed on all eyes to detect the presence of any defects.
- Indication of any antibiotics used: Antibiotic used during transport in buffered Hanks medium [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)]. - Vehicle:
- other: paraffin oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):750 µL (± 8 µL) applied on each cornea.
- Concentration (if solution) :20% (w/v) in the paraffin oil
VEHICLE
- Amount(s) applied (volume or weight with unit):750 µL (± 8 µL)
- Duration of treatment / exposure:
- 4 hours (± 5 minutes)
- Duration of post- treatment incubation (in vitro):
- As the test item is solid no post-exposure incubation was required.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Every eye with some defects was discared.The examination of defects was performed under a lamp, using HBSS. The tissues surrounding the eyeball were carefully pulled away and the cornea, surrounded by approximately 2 to 3 mm of sclera, was dissected out. The isolated corneas were stored in HBSS until all corneas had been prepared. The corneas were washed for 15 minutes, three times, in HBSS plus penicillin/streptomycin (100 units/100 µg/mL final) at room temperature. The corneas were used within a maximum of 24 hours. As the corneas were not used immediately, they were stored after washing. Each cornea was stored individually in 12 mL of M199 medium containing 5% dextran, plus penicillin/streptomycin, at +4°C, for a maximum of 24 hours before use.
QUALITY CHECK OF THE ISOLATED CORNEAS: A pre-incubation was performed before treatment aplication. Both chambers of the corneal holder were filled with MEM culture media supplemented with 1% fetal bovine serum plus penicillin/streptomycin (cMEM) at room temperature. After making sure that no air bubbles were present within the holder, it was immersed in a water bath, horizontally (cornea positioned vertically), up to approximately three quarters of its height. The holders were pre incubated for 1 hour and 5 minutes (± 5 minutes) at +32°C (± 1°C). At the end of the pre-incubation period, the corneas were examined macroscopically through the holder to detect the presence of any defects. Then, the opacity of the cornea was measured to obtain OPT0. Corneas that showed any macroscopic defect or an OPT0 value over 7 were discarded.
NUMBER OF REPLICATES:3
SOLVENT CONTROL USED (if applicable): Yes, paraffin oil
POSITIVE CONTROL USED: Yes, 20% imidazole solution in 0.9% NaCl (w/w).
APPLICATION DOSE AND EXPOSURE TIME: 750 µL (± 8 µL) of 20% (w/w) in the paraffin oil, 4 hours exposure.
TREATMENT METHOD: The open-chamber method was used for the test item to ensure uniform spreading of the test item formulation over the corneas. The closed chamber was used for the vehicle/positive controls.
The medium of the anterior chamber was removed and the each item was applied onto the epithelium of the cornea. The treatment time of each series of three corneas was carefully measured with a chronometer. After application of the items, the holders were incubated vertically (cornea positioned horizontally with the treated side uppermost) in a water bath at +32°C (± 1°C), for 4h.
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The test item formulation was removed with a cotton bud and a pipette of heated cMEM (32°C).The corneas were rinsed four times with pre-warmed cMEM containing phenol red until it was visually confirmed by observing the transparency and the colour changing of the rinsing medium (containing phenol red).Then, the corneas were finally rinsed with pre-warmed cMEM without phenol red.
- POST-EXPOSURE INCUBATION: No
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:An opacitometer (OPKIT opacitometer and calibrators (MC2, Clermont-Ferrand, France)) was used to measure light transmission (the level of opacity) through the center of each mounted cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry Cary 100 (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS). The following formula was used to determine the In Vitro Irritancy Score (IVIS): IVIS = cOPT + (15 x cOD490 nm)
The IVIS was calculated for each test item and positive control cornea. The mean IVIS for each series of three corneas was calculated from the individual scores.
DECISION CRITERIA: as indicated in the TG.
IVIS UN GHS
If the test item induces an IVIS ≤ 3 No category
If the test item induces an 3 < IVIS ≤ 55 No prediction can be made
If the test item induces an IVIS > 55 Category 1 - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- ca. 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability
- Run / experiment:
- Mean
- Value:
- ca. 0.016
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes, full validation dossier is available in laboratory GLP archive for review or inspection purpose.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the mean opacity (0.0) and mean OD490 nm of the vehicle control corneas (0.023) should be less than the established upper limit of historical mean ( acceptable range: opacity <= 4, mean OD490 <=0.043).
- Acceptance criteria met for positive control: Yes, the mean In Vitro Irritancy Score (IVIS) of the positive control corneas (163) should fall within two standard deviations of the historical mean (mean+2SD=168.85, acceptable range 113-169).
- Irritant / corrosive response data:
- Due to that the test item induces an IVIS of 0.0 (this is ≤ 3), the test item has no irritation potential to eye. A single experiment composed of three corneas was sufficient for the test item formulation since the resulting classification was unequivocal. Please see "Any other information on results incl. tables" for more details about individual values.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- No irritating
- Conclusions:
- Under the experimental conditions of this study, the test item has been identified as not irritant to eye, not requiring classification for eye irritation or serious eye damage (UN GHS No Category).
- Executive summary:
An in vitro (ex vivo) Bovine Corneal Opacity and Permeability study was conducted in order to determine the potential severe eye damaging effects of the test item according to the OECD guideline 437 under GLP conditions. Corneas were obtained from freshly slaughtered calves.
A single experiment was performed using three corneas for each treated series ( test item, positive control and vehicle control). Before treatment, opacity measurements were conducted. Then, the test item was applied at the concentration 20% (w/v) in the vehicle (paraffin oil), using a treatment time of 4 hours and the open-chamber method. Vehicle and positive controls were applied using the same treatment time and using the closed-chamber method. After exposure, all items were removed from the front opening of the anterior chamber and the epithelia were rinsed. Then the opacity cornea was measured. On the other hand, for measuring the permeability a fluorescein solution was used and the holders were incubated. After this procedure, the OD490 nm was measured and the corneas were examined for irregularities. The mean corneal opacity and the mean IVIS for the test item was 0, whereas the mean permeability was 0.016. All validity criteria were fulfilled. Therefore test item is considered not irritating to eye (no category).
Reference
Results:
Vehicle control |
Opacity |
Permeability |
||||
HOLDER |
OPT0 |
OPT2 |
OPT2-OPT0 |
NEG. correction |
OD490nm |
NEG. correction |
72 |
1 |
0 |
-1 |
0 |
0.031 |
0.031 |
77 |
1 |
0 |
-1 |
0 |
0.023 |
0.023 |
53 |
1 |
1 |
0 |
0 |
0.016 |
0.016 |
Mean |
|
|
|
0.0 |
|
0.023 |
SD |
|
|
|
0.0 |
|
0.008 |
Test item |
Opacity |
Permeability |
|||||||
HOLDER |
OPT0 |
OPT2 |
OPT2-OPT0 |
NEG. correction |
cOPT |
OD490nm |
NEG. correction |
cOD490nm |
IVIS |
83 |
0 |
0 |
0 |
0 |
0 |
0.032 |
0.032 |
0.009 |
0 |
55 |
1 |
0 |
-1 |
0 |
0 |
0.013 |
0.013 |
0.000 |
0 |
50 |
2 |
2 |
0 |
0 |
0 |
0.063 |
0.063 |
0.040 |
1 |
Mean |
|
|
|
|
0.0 |
|
0.023 |
0.016 |
0 |
SD |
|
|
|
|
0.0 |
|
0.008 |
0.021 |
0.3 |
POSITIVE CONTROL |
Opacity |
Permeability |
|||||||
HOLDER |
OPT0 |
OPT2 |
OPT2-OPT0 |
NEG. correction |
cOPT |
OD490nm |
NEG. correction |
cOD490nm |
IVIS |
73 |
0 |
110 |
110 |
110 |
110 |
3.264 |
3.264 |
3.241 |
159 |
79 |
1 |
123 |
122 |
122 |
122 |
3.228 |
3.228 |
3.205 |
170 |
61 |
2 |
114 |
112 |
112 |
112 |
3.192 |
3.192 |
3.169 |
160 |
Mean |
|
|
|
|
114.7 |
|
|
3.205 |
163 |
SD |
|
|
|
|
6.4 |
|
|
0.036 |
6.4 |
Np- not performed
OD: optical density
cOD-optical density corrected by mean OD value of vehicle control
cOPT: corneal opacity corrected by mean opacity value of vehicle control
OPT0: corneal opcity before treatment
OPT2: corneal opacity after treatment
Neg. correction: all individual values below 0 are set at 0
SD: standart deviations
IVIS:in vitro irritation source
Vehicle control: Parrafin oil
Positive control: 20% imidazole solution in 0.9 & NaCl
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation: Key study: The aim of the study was to evaluate the possible irritating effects of the test item after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model). This test was performed according to OECD TG 439 (GLP study). The test item was applied at the dose of 16 mg, to 3 living Reconstructed Human epidermis during 42 minutes, followed by a rinse with 25 mL of DPBS and a 42 hours and 30 minutes post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The mean corrected percent viability of the treated tissues was 71.8%, versus 2.9 % in the positive control (5% Sodium Dodecyl Sulfate). The test item has to be considered as Non-irritant to skin, corresponding to UN GHS No Category.
Eye irritation: A first study was conducted with the test item according to Isolated Chicken Eye Test Method and the results indicate that no prediction can be made.
Weight of evidence: An in vitro (ex vivo) study was conducted in order to determine the potential severe eye damaging effects of the test item according to the OECD guideline 438 (GLP study). Three eyeballs per group were isolated from chickens and, after appropriate preparation, were exposed to either 30 mg of the test item, 30 mg of sodium hydroxide (positive control) or 30μL of physiological saline (negative control).According to the overall in vitro classification (UN GHS), no prediction can be made since the combinations of the 3 endpoints for the test item were 2 x II, 1 x I.
Due to that results from this first in vitro study do not allow a conclusive decision on the classification of the substance or the absence of eye irritation potential, an other in vitro study for this endpoint has been considered. The Bovine Corneal Opacity and Permeability study has been conducted.
Weight of evidence: An in vitro (ex vivo) Bovine Corneal Opacity and Permeability study was conducted in order to determine the potential severe eye damaging effects of the test item according to the OECD guideline 437 under GLP conditions. A single experiment was performed using three corneas for each treated series ( test item, positive control and vehicle control). Before treatment, opacity measurements were conducted. Then, the test item was applied at the concentration 20% (w/v) in the vehicle, for 4 hours with the open-chamber method. Vehicle and positive controls were applied using the closed-chamber method. After exposure, all items were removed and the epithelia were rinsed. Then the opacity cornea was measured. On the other hand, for measuring the permeability a fluorescein solution was used and the holders were incubated. After this procedure, the OD490 nm was measured and the corneas were examined for irregularities. The mean corneal opacity and the mean IVIS for the test item was 0, whereas the mean permeability was 0.016. All validity criteria were fulfilled. Therefore test item is considered not irritating to eye (no category).
Justification for classification or non-classification
Based on the available information, the test item is not classified for irritation/corrosion, in accordance with CLP Regulation (EU) No. 1272/2008.
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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