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EC number: 610-204-7 | CAS number: 446299-90-7
- 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 (in vitro): Key study. Test method according to OECD 439, GLP study. The mean percent viability of the treated tissues was 90.5%, versus 1.9% in the positive control (5% SDS). Therefore, the test item is not irritant to the skin.
Eye irritation (in vitro): Key study. Test method according to OECD 438, GLP study. The test item does not require classification for serious eye damage/eye irritation since the combination of the 3 endpoints assessed in the ICE test ( fluorescein retention, corneal opacity and corneal swelling) was 2x I and 1xII.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July 2020 - 27 August 2020
- 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)
- Test system:
- human skin model
- Remarks:
- (SkinEthic RHE® model)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Justification for test system used:
- The SkinEthic RHE® model has been validated for irritation testing 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)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 20-RHE-104
- Production date: N/A
- Shipping date: 25.08.2020
- Delivery date: 25.08.2020
- Date of initiation of testing: 25.08.2020
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: 3 hours and 5 min at 37ºC, 5% CO2
- Spectrophotometer: ELx800 absorbance microplate reader (BioTek)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: O.D. = 1.0 (Acceptance criterion: >0.7). Historical negative control mean OD range = 0.530-1.211 (OD measured after 1:2 dilution in isopropanol; acceptability criteria should be in the range ≥ 0.4 and ≤1.5)
- Barrier function: 5.5 h (Acceptance criterion: 4.0h ≤ ET50 ≤10.0h)
- Morphology: 6 Cell layers (specification ≥ 4). Multi-layered, highly differenciated epidermis consisting of organized basal, spinous and granular layers and a multilayered stratum corneum.
- Contamination: No
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: there is no direct interaction between the test item and MTT.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test item is considered as non-irritant to skin if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non corrosive”.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test. - 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 (32 mg/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 42 min at room temperature.
- Duration of post-treatment incubation (if applicable):
- 41 hours and 29 min at 37ºC, 5% CO2.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 90.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (distilled water)
- Positive controls validity:
- valid
- Remarks:
- 1.9% viability (5% SDS)
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A full demonstration of proficiency was performed for the EpiSkin model, plus a reduced validation with the SkinEthic RHE model, having into account that both models are very similar. Adequate results were obtained for the evaluated chemicals.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, mean OD = 0.892 (OD measured after 1:2 dilution in isopropanol; criterion for acceptability should be in the range ≥ 0.4 and ≤1.5).
- Acceptance criteria met for positive control: yes, mean viability = 1.9% (criterion for acceptability should be < 40%).
- Acceptance criteria met for variability between replicate measurements: yes. SD of negative, positive and test item replicates were 8.3, 0.5 and 5.2% respectively (criterion for acceptability, SD ≤ 18%). - Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance can be considered as not irritant to skin as the mean percent viability of the treated tissues was found 90.5% in the in vitro RhE test.
- Executive summary:
An in vitro skin irritation test was conducted for the test item in a reconstructed human epidermis model ( SkinEthic™) according to OECD TG 439 (GLP study). Three epidermis units, previously moistened with 10 μL of distilled water, were treated with 16 mg test item for 42 minutes at room temperature. Exposure of the test item was terminated by rinsing with 25 x 1 mL of DPBS. The epidermis units were then incubated for the post-treatment incubation period for 41 hours and 29 minutes post-treatment incubation period in growth medium (Episkin SA, batch No. 20 SGM 064) at 37ºC, 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT, extracting the precipitated formazan crystals using isopropanol during 2 hours under gentle agitation in the dark, and measuring the concentration of formazan by determining the OD at 570 nm, just after dilution of the extracts 1:2 in isopropanol. Under the test conditions, the mean percent viability of the treated tissues was 90.5%, versus 1.9% in the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item is considered as not irritant to the skin.
Reference
Table 1. Table of results
|
Well ID |
OD |
Mean OD / disc (#) |
Mean OD / product |
Viability % |
Meanviability % |
SD viability |
Conclusion |
|
|
0.911 |
|
|
|
|
|
|
|
SPL1 |
0.795 |
0.848 |
|
95.1 |
|
|
|
|
|
0.838 |
|
|
|
|
|
|
Negativecontrol |
SPL2 |
0.859 0.838 0.855 |
0.850 |
0.892 |
95.3 |
100.0 |
8.3 |
|
|
|
0.996 |
|
|
|
|
|
|
|
SPL3 |
0.979 |
0.977 |
|
109.6 |
|
|
|
|
|
0.956 |
|
|
|
|
|
|
|
|
0.028 |
|
|
|
|
|
|
|
SPL4 |
0.020 |
0.022 |
|
2.5 |
|
|
|
|
|
0.020 |
|
|
|
|
|
|
Positive control |
SPL5 |
0.018 0.016 0.017 |
0.017 |
0.017 |
1.9 |
1.9 |
0.5 |
Irritant |
|
|
0.014 |
|
|
|
|
|
|
|
SPL6 |
0.013 |
0.013 |
|
1.5 |
|
|
|
|
|
0.014 |
|
|
|
|
|
|
|
|
0.887 |
|
|
|
|
|
|
|
SPL10 |
0.822 |
0.846 |
|
94.9 |
|
|
|
|
|
0.830 |
|
|
|
|
|
|
Test item PH-20/0572 |
SPL11 |
0.762 0.756 0.750 |
0.756 |
0.807 |
84.8 |
90.5 |
5.2 |
Non irritant |
|
|
0.832 |
|
|
|
|
|
|
|
SPL12 |
0.813 |
0.820 |
|
92.0 |
|
|
|
|
|
0.817 |
|
|
|
|
|
|
# mean of 3 values (triplicate of the same extract).
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:
- key study
- Study period:
- 03 August 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- yes
- Remarks:
- Time from collection of the heads to enucleation was 2 h and 25 min instead of 2 h. As the results obtained with controls were as expected, this deviation is considered as without impact.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- chicken
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France) where they are killed for human consumption.
- Number of animals: Not specified.
- Characteristics of donor animals (e.g. age, sex, weight): 7 weeks old. 1.5 - 2.5 kg.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Because eyes were dissected in the laboratory, the intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline.
- Time interval prior to initiating testing: 2 hours and 25 min.
- indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: no - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):30 mg of test item - Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- No post-treatment incubation is performed.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
The eyelids were carefully excised, taking care not to damage the cornea. Then, the eye was further dissected from the skull, taking care not to damage the cornea. The eyeball was pulled from the orbit by holding the nictitating membrane firmly with surgical forceps, and the eye muscles were cut with a bent, blunt-tipped scissor. When the eye is removed from the orbit, a visible portion of the optic nerve should be left attached. Once removed from the orbit, the eye was placed on an absorbent pad and the nictitating membrane and other connective tissue were cut away.
The enucleated eye was mounted in a stainless steel clamp with the cornea positioned vertically. The clamp was then transferred to a chamber of the superfusion apparatus. The clamps were positioned in the superfusion apparatus such that the entire cornea was supplied with the physiological saline drip (in the range 0.1 to 0.15 mL/min). The chambers of the superfusion apparatus was temperature controlled between 31.9ºC and 32.0ºC.
After being placed in the superfusion apparatus, the eyes were examined with a slit-lamp microscope to ensure that they have not been damaged during the dissection procedure using sodium fluorescein. Corneal thickness was also measured at this time at the corneal apex using the depth measuring device on the slit-lamp microscope.
Eyes with; (i), a fluorescein retention score of > 0.5; (ii) corneal opacity > 0.5; or, (iii), any additional signs of damage were replaced. For eyes that were not rejected based on any of these criteria, individual eyes with a corneal thickness deviating more than 10% from the mean value for all eyes were rejected. (see table appendix No.4 on "Any other information on results incl. tables")
Once all eyes had been examined and approved, the eyes were incubated between 45 and 65 minutes to equilibrate them to the test system prior to dosing.
EQUILIBRATION AND BASELINE RECORDINGS:
Eyes were incubated between 45 and 64 minutes to equilibrate them to the test system prior to dosing (TG indicates approximately 45 to 60 min. This deviation is considered as without impact on the conclusion of the study).
Following the equilibration period, a zero reference measurement was recorded for corneal thickness and opacity to serve as a baseline (i.e., time = 0). The fluorescein score determined at dissection was used as the baseline measurement for that endpoint.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED
30 μL physiological saline - Dutscher Batch No. 3014011 (one eye)
SOLVENT CONTROL USED: not applicable.
POSITIVE CONTROL USED
Sodium hydroxide – Fisher Scientific, Batch No. 1550248 - 30 mg (three eyes)
APPLICATION DOSE AND EXPOSURE TIME
30 mg of the test item was applied for 10 seconds.
OBSERVATION PERIOD:Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes (± 5 minutes) after the post-treatment rinse.
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: the eyes were rinsed twice with 10 mL of physiological saline at ambient temperature.
- Indicate any deviation from test procedure in the Guideline: NO
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: It was calculated by using the area of the cornea that was most densely opacified for scoring. The mean corneal opacity value for all test eyes was calculated for all observation time points (see table 4)
- Damage to epithelium based on fluorescein retention: Fluorescein retention value for all test eyes was calculated for the 30-minute observation time point only, which was used for the overall category score given for each test or control item (see table 5)
- Swelling: optical pachymeter on a slit-lamp microscope ((HaagStreit BP900 slit-lamp microscope with depth-measuring device no. I). The slit-width was set at 9 1/2 equalling 0.095 mm. The mean percentage of corneal swelling for all test eyes was calculated for all observation time points. Based on the highest mean score for corneal swelling, as observed at any time point, an overall category score was then given for each test item (see table 3).
- Macroscopic morphological damage to the surface: The aim of this evaluation was to determine whether any “pitting” of corneal epithelial cells, “loosening” of epithelium, “roughening” of the corneal surface and “sticking” of the test item to the cornea were visible.These findings can vary in severity and may occur simultaneously.
SCORING SYSTEM:
- Mean corneal swelling: It was expressed as a percentage and was calculated from corneal thickness measurements according to the following formula:
(corneal thickness measurement at time t - corneal thickness at time=0 / corneal thickness at ime=0 )*100
- Mean maximum opacity score:
0 - No opacity,
0.5 -Very faint opacity
1- Scattered or diffuse areas; details of the iris clearly visible
2- Easily discernible translucent area; details of the ris are slightly obscured,
3-Severe corneal opacity; no specific details of the iris are visible; size of the pupil is barely discernible
4-Complete corneal opacity; iris invisible
- Mean fluorescein retention score at 30 minutes post-treatment :
0-No fluorescein retention,
0.5-Very minor single cell staining,
1-Single cell staining scattered throughout the treated area of the cornea,
2-Focal or confluent dense single cell staining,
3-Confluent large areas of the cornea retaining fluorescein
DECISION CRITERIA: Decision criteria was used as indicated in the TG. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Highest mean
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- ICE Class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean at 30 minutes post-treatment
- Value:
- 0.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- ICE class II
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Highest mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- ICE class I
- Irritation parameter:
- morphological effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No effects
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: NO, no morphological effects were noted, whatever the examination time.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: YES, the combination of the three endpoints for the negative control, physiological saline, was 3xI classified as “No Category”
- Acceptance criteria met for positive control: YES, the combination of the three endpoints for the positive control, sodium hydroxide, was 3 x IV,classified as “Corrosive/Severe Irritant ” - Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test item was determined to not cause severe damage or irrritation for eyes in the ICE test.
- Executive summary:
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 under GLP conditions. Eyeballs were isolated from chickens killed for human consumption and after the appropriate preparation were exposed to either 30 mg of the test item, 30 mg of sodium hidroxide (positive control) or 30μL of physiological saline (negative control). Three eyeballs were used in test item and positive groups, and one for the negative control group. Fluorescein retention, corneal opacity and corneal swelling were evaluated, then the results of each endpoint were assigned to ICE classes according to OECD guideline 438. According to CLP Regulation EC no. 1272/2008 the test item does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No category), since the combination of the 3 endpoints for the test item was 2x I and 1xII.
Reference
Appendix No. 4: Selected eyes for the performance of the ICE test
Chamber |
Fluoresceinretention |
Cornealopacity |
Morphological effects |
Corneal thickness (e) |
n°1 |
0.5 |
0 |
N.t.R. |
0.51 |
n°2 |
0.5 |
0 |
N.t.R. |
0.53 |
n°3 |
0.5 |
0 |
N.t.R. |
0.52 |
n°4 |
0.5 |
0 |
N.t.R. |
0.54 |
n°5 |
0.5 |
0 |
N.t.R. |
0.55 |
n°6 |
0.5 |
0 |
N.t.R. |
0.56 |
n°7 |
0.5 |
0 |
N.t.R. |
0.52 |
n°8 |
0.5 |
0 |
N.t.R. |
0.51 |
n°9 |
0.5 |
0 |
N.t.R. |
0.56 |
n°10 |
0.5 |
0 |
N.t.R. |
0.55 |
n°11 |
0.5 |
0 |
N.t.R. |
0.54 |
n°12 |
0.5 |
0 |
N.t.R. |
0.55 |
n°13 |
0.5 |
0 |
N.t.R. |
0.50 |
n°14 |
0.5 |
0 |
N.t.R. |
0.52 |
n°15 |
0.5 |
0 |
N.t.R. |
0.50 |
n°16 |
0.5 |
0 |
N.t.R. |
0.52 |
Mean corneal thickness value= Range of accepted thickness: |
0.53 0.48 ≤ e ≤ 0.58 |
N.t.R: Nothing to report
Table 9: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Test item
Endpoint measured |
Eye No. |
Time (min |
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal opacity |
13 |
0 |
0 |
0 |
0 |
0 |
0 |
14 |
0 |
0 |
0 |
0 |
0 |
0 |
|
15 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
ICE class |
|
I |
|||||
Fluorescein retention |
13 |
0.5 |
0.5 |
- |
- |
- |
- |
14 |
0.5 |
0.5 |
- |
- |
- |
- |
|
15 |
0.5 |
1 |
- |
- |
- |
- |
|
Mean |
0.5 |
0.7 |
- |
- |
- |
- |
|
ICE class |
|
II |
|||||
Corneal thickness |
13 |
0.50 |
0.50 |
0.50 |
0.50 |
0.50 |
0.50 |
14 |
0.52 |
0.52 |
0.52 |
0.52 |
0.52 |
0.52 |
|
15 |
0.50 |
0.51 |
0.52 |
0.52 |
0.52 |
0.52 |
|
Corneal swelling (%) |
13 |
- |
0 |
0 |
0 |
0 |
0 |
14 |
- |
0 |
0 |
0 |
0 |
0 |
|
15 |
- |
2 |
4 |
4 |
4 |
4 |
|
Mean |
- |
1 |
1 |
1 |
1 |
1 |
|
ICE class |
|
I |
|||||
Combination of the 3 Endpoints |
2 x I, 1 x II |
||||||
CLASSIFICATION |
No Category |
Note: No morphological effects were noted, whatever the examination time.
Table 8: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Positive control
Endpoint measured |
Eye No. |
Time (min)
|
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal opacity |
1 |
0 |
4 |
4 |
4 |
4 |
4 |
2 |
0 |
4 |
4 |
4 |
4 |
4 |
|
3 |
0 |
4 |
4 |
4 |
4 |
4 |
|
Mean |
0.0 |
4.0 |
4.0 |
4.0 |
4.0 |
4.0 |
|
ICE class |
|
IV |
|||||
Fluorescein retention |
1 |
0.5 |
3 |
- |
- |
- |
- |
2 |
0.5 |
3 |
- |
- |
- |
- |
|
3 |
0.5 |
3 |
- |
- |
- |
- |
|
Mean |
0.5 |
3.0 |
- |
- |
- |
- |
|
ICE class |
|
IV |
|||||
Corneal thickness |
1 |
0.51 |
|
- |
- |
- |
- |
2 |
0.53 |
- |
- |
- |
- |
- |
|
3 |
0.52 |
- |
- |
- |
- |
- |
|
Corneal swelling (%) |
1 |
(-) |
(-) |
(-) |
(-) |
(-) |
(-) |
2 |
(-) |
(-) |
(-) |
(-) |
(-) |
(-) |
|
3 |
(-) |
(-) |
(-) |
(-) |
(-) |
(-) |
|
Mean |
- |
- |
- |
- |
- |
- |
|
ICE class |
|
IV |
|||||
Combination of the 3 Endpoints |
3 x IV |
||||||
CLASSIFICATION |
Category 1 : Corrosive / Severe irritant |
Note:
( - ): evaluation of corneal swelling not possible (Corneal opacity = 4 at each examination time)
Table 7: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Negative control
Endpoint measured |
Eye No. |
Time (min)
|
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal opacity |
16 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
ICE class |
|
I |
|||||
Fluorescein retention |
16 |
0.5 |
0.5 |
- |
- |
- |
- |
ICE class |
|
I |
|||||
Corneal thickness |
16 |
0.52 |
0.52 |
0.52 |
0.52 |
0.52 |
0.52 |
Corneal swelling (%) |
16 |
- |
0 |
0 |
0 |
0 |
0 |
ICE class |
|
I |
|||||
Combination of the 3 Endpoints |
3 x I |
||||||
CLASSIFICATION |
No Category |
Note: No morphological effects were noted, whatever the examination time.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available information, the substance is not classified for skin irritation/corrosion in accordance with CLP, Regulation (EC) No. 1272/2008.
Based on the available information, the substance is not classified for serious eye damage/eye irritation according to CLP Regulation no. 1272/2008.
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