Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 217-586-0 | CAS number: 1895-39-2
- 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 the OECD Guideline 439 with GLP study. The test item was performed with the reconstructed human SkinEthic RHE®model. The mean percent viability of the treated tissues was 89.7% versus 1.4% in the positive control. Therefore, the test item must be considered as Non-irritant to skin.
Eye irritation (in vitro): Weight of Evidence. Test method according to the OECD Guideline 438 with GLP. The test item was determined to be classified in Category 1 "Irevversible effects on the eyesince the combination of the 3 endpoints was 3 x IV.
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:
- 07 June 2022 - 30 June 2022
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Remarks:
- (SkinEthic RHE model)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- 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
- Tissue batch number(s): 22-RHE-089
- Delivery date: 28.06.2022
- Date of initiation of testing: 28.06.2022
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 at 37°C, 5% CO2
- Spectrophotometer: ELx800 absorbance microplate reader (BioTek)
- Wavelength: 570 nm
- Linear OD range of spectrophotometer: not specified.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD=1.2 (CV = 0.7%) specification OD > 0.7. Historical negative control mean OD range =0.402-1.402 (measured after a 1:2 dilution of the extracts in isopropanol).
- Barrier function: 8.4 h (Specification 4.0h < ET50< 10.0h)
- Morphology: 6 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.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin (or corrosive) if the viability after 42 minutes exposure and 42 hours of post-treatment incubation 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 and 42 hours of post-treatment incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Application: 16 mg of the test item on 0.50 cm2 human skin model
- Application date: 28 June 2022 - Duration of treatment / exposure:
- 42 min at room temperature.
- Duration of post-treatment incubation (if applicable):
- 41 hours and 06 minutes
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 89.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 1.4% viability (5% SD)
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The mean percent viability of the treated tissues was 89.7% versus 1.4% in the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item has to be considered as Non-irritant to skin.
ACCEPTABILITY CRITERIA:
- SD value of the % viability ≤18%
- Negative control: OD values of the 3 replicates in the range ≥ 0.8 and ≤ 3.0.
The optical density was measured a 1:2 dilution of the formazan extracts in isopropanol; the acceptability criteria should be in the range ≥ 0.4 and ≤ 1.5.
- Positive control: Mean viability <40%.
Note:
- If the viability obtained for the test is greater than 50%, the test item has to be considered as non-irritant.
- If the viability obtained for the test item is less than or equal to 50% and the result of skin corrosion test is non-corrosive, the test item has to be considered as irritant.
- If the viability obtained for the test item is less than or equal to 50% and in absence of information on skin corrosion, the test item has to be considered as corrosive or irritant. - 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 89.7%
- Executive summary:
An in vitro skin irritation test was conducted for the test item in a reconstructed human epidermis model (EpiDerm™) 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 a 41 hours and 06 minutes hours post-treatment incubation period in fresh medium at 37ºC, 5% CO2, then placed into 300 μL of fresh new assay medium during 3 hours and 45 minutes, 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 89.7%, versus 1.4% 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 % | Mean viability % | SD viability | Conclusion | |
Negative control | SPL 1 | 1.022 | 1.063 | 0.989 | 107.4 | 100.0 | 7.7 | No Category |
1.088 | ||||||||
1.081 | ||||||||
SPL 2 | 1.012 | 0.994 | 100.5 | |||||
0.970 | ||||||||
1.000 | ||||||||
SPL 3 | 0.877 | 0.911 | 92.1 | |||||
0.936 | ||||||||
0.921 | ||||||||
Positive control | SPL 4 | 0.013 | 0.014 | 0.014 | 1.4 | 1.4 | 0.2 | Category 2 "Irritant" |
0.015 | ||||||||
0.014 | ||||||||
SPL 5 | 0.012 | 0.012 | 1.2 | |||||
0.013 | ||||||||
0.013 | ||||||||
SPL 6 | 0.016 | 0.016 | 1.6 | |||||
0.016 | ||||||||
0.017 | ||||||||
Test item PH-22/0352 | SPL 10 | 0.928 | 0.926 | 0.887 | 93.6 | 89.7 | 6.0 | No Category |
0.929 | ||||||||
0.923 | ||||||||
SPL 11 | 0.826 | 0.819 | 82.8 | |||||
0.817 | ||||||||
0.816 | ||||||||
SPL 12 | 0.908 | 0.917 | 92.7 | |||||
0.919 | ||||||||
0.925 |
# 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:
- 19 July 2022
- 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:
- no
- 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: 1 hours and 30 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 32.0ºC and 32.1ºC.
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.
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 65 minutes to equilibrate them to the test system prior to dosing
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
10 mL physiological saline - Dutscher Batch No. C0817A02 (one eye)
SOLVENT CONTROL USED: not applicable.
POSITIVE CONTROL USED
Sodium hydroxide – Fisher Scientific, Batch No. 0000080257 (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
- 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.
- Swelling: optical pachymeter on a slit-lamp microscope. 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
- 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 - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Highest mean
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class IV
- Remarks:
- ICE Class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean at 30 minutes post-treatment
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class IV
- Remarks:
- ICE class I
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Highest mean
- Value:
- 42
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class IV
- Remarks:
- ICE class II
- 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: Category 1 "Irreversible effects on the eye" (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test item was determined to be classified in Category 1 "Irreversible effects on the eye" 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 10μL 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 was determined to be classified in Category 1 "Irreversible effects on the eye", since the combination of the 3 endpoints for the test item was 3 x IV.
Reference
Table. 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. | 0.46 |
n°2 | 0.5 | 0 | N.t.R. | 0.44 |
n°3 | 0.5 | 0 | N.t.R. | 0.48 |
n°4 | 0.5 | 0 | N.t.R. | 0.46 |
n°5 | 0.5 | 0 | N.t.R. | 0.48 |
n°6 | 0.5 | 0 | N.t.R. | 0.48 |
n°7 | 0.5 | 0 | N.t.R. | 0.46 |
n°8 | 0.5 | 0 | N.t.R. | 0.46 |
n°9 | 0.5 | 0 | N.t.R. | 0.46 |
n°10 | 0.5 | 0 | N.t.R. | 0.48 |
n°11 | 0.5 | 0 | N.t.R. | 0.48 |
n°12 | 0.5 | 0 | N.t.R. | 0.46 |
n°13 | 0.5 | 0 | N.t.R. | 0.48 |
nº 14 | 0.5 | 0 | N.t.R. | 0.48 |
nº 15 | 0.5 | 0 | N.t.R. | 0.46 |
nº 16 | 0.5 | 0 | N.t.R. | 0.48 |
Mean corneal thickness value= Range of accepted thickness: | 0.47 0.42 ≤ e ≤ 0.52 |
N.t.R: Nothing to report
Table 5: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Test item
Endpoint measured | Eye No. | Time (min | |||||
-45 | 30 | 75 | 120 | 180 | 240 | ||
Corneal opacity | 7 | 0 | 4 | 4 | 4 | 4 | 4 |
8 | 0 | 4 | 4 | 4 | 4 | 4 | |
9 | 0 | 4 | 4 | 4 | 4 | 4 | |
Mean | 0.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | |
ICE class |
| IV | |||||
Fluorescein retention | 7 | 0.5 | 3 | - | - | - | - |
8 | 0.5 | 3 | - | - | - | - | |
9 | 0.5 | 3 | - | - | - | - | |
Mean | 0.5 | 3.0 | - | - | - | - | |
ICE class |
| IV | |||||
Corneal thickness | 7 | 0.46 | 0.60 | 0.60 | 0.62 | 0.62 | 0.66 |
8 | 0.46 | 0.54 | 0.56 | 0.58 | 0.62 | 0.66 | |
9 | 0.46 | 0.56 | 0.56 | 0.60 | 0.60 | 0.64 | |
Corneal swelling (%) | 7 | - | 30 | 30 | 35 | 35 | 43 |
8 | - | 17 | 22 | 26 | 35 | 43 | |
9 | - | 22 | 22 | 30 | 30 | 39 | |
Mean | - | 23 | 25 | 30 | 33 | 42 | |
ICE class |
| IV | |||||
Combination of the 3 Endpoints | 3 x IV | ||||||
CLASSIFICATION | Category 1 "Corrosive / Severe Irritant" |
Note: No morphological effects were noted, whatever the examination time.
Table 6: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Positive control
Endpoint measured | Eye No. | Time (min)
| |||||
-45 | 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 | 0.46 | 0.70 | 0.82 | 0.84 | - | - |
2 | 0.44 | 0.68 | 0.70 | 0.72 | - | - | |
3 | 0.48 | 0.70 | 0.78 | 0.82 | - | - | |
Corneal swelling (%) | 1 | 0 | 52 | 78 | 83 | - | - |
2 | 0 | 48 | 52 | 57 | - | - | |
3 | 0 | 52 | 70 | 78 | - | - | |
Mean | 0.0 | 51 | 67 | 72 | - | - | |
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)
Severe loosening of the corneal epithelium noted from 30 minutes post-dose in eyes No. 1, No. 2 and No. 3
Table 7: INDIVIDUAL AND AVERAGE VALUES FOR EVALUATION OF CORNEAL LESIONS AFTER TREATMENT
Negative control
Endpoint measured | Eye No. | Time (min)
| |||||
-45 | 30 | 75 | 120 | 180 | 240 | ||
Corneal opacity | 16 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean
| 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
ICE class |
| I | |||||
Fluorescein retention | 16 | 0.5 | 0.5 | - | - | - | - |
Mean
| 0.5 | 0.5 | - | - | - | - | |
ICE class |
| I | |||||
Corneal thickness | 16 | 0.48 | 0.48 | 0.48 | 0.48 | 0.48 | 0.48 |
Corneal swelling (%) | 16 | 0 | 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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation/corrision: Based on the available data, the substance is considered as Non-irritant to skin according to CLP Regulation no. 1272/2008.
Eye damage/irritation: Based on the available data, the substance is classified as eye irritant (Cat 1) according to CLP Regulation 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.