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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-911-1 | CAS number: 61698-32-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 20 August 2021 to April 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to the OECD TG 438 with minor deviations not affecting the reliability of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 25 June 2018
- Deviations:
- yes
- Remarks:
- During preparation, eye were dissected from the skull before the assessment of corneal integrity. This deviation has no impact on the study reliability as it has been validated by there CRO and is part of their standard SOP.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- EC Number:
- 262-911-1
- EC Name:
- 4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole
- Cas Number:
- 61698-32-6
- Molecular formula:
- C11H12N2O2
- IUPAC Name:
- [4-(hydroxymethyl)-2-phenyl-1H-imidazol-5-yl]methanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white to light-pink powder
- Storage: Keep away from heat and sources of ignition. Store in tightly closed container. Store in a well-ventilated place. Store in a cool, dark place.
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep away from heat and sources of ignition. Store in tightly closed container. Store in a well-ventilated place. Store in a cool, dark place at room temperature (20°C ± 10°C)
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: NA
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: NA
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: NA
- Reactivity of the test material with the incubation material used (e.g. plastic ware): NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): NA
- Preliminary purification step (if any): NA
- Final concentration of a dissolved solid, stock liquid or gel: NA
- Final preparation of a solid (e.g. stock crystals ground to fine powder using a mortar and pestle): NA
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Specify the relevant form characteristics if different from those in the starting material, such as state of aggregation, shape of particles or particle size distribution: NA
Test animals / tissue source
- Species:
- chicken
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Etablissement Brun, 33820 Etauliers, France
- Number of animals: Not stated
- Characteristics of donor animals (e.g. age, sex, weight):Spring chickens, 7 weeks old, 1.5 - 2.5kg
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline. Heads collected from source at 8:45am and eyes enucleated at ICARE at 10.53am.
- Time interval prior to initiating testing: 45 minutes
- Indication of any existing defects or lesions in ocular tissue samples: Eyes where ocular lesions were present were discarded prior to testing.
- Indication of any antibiotics used: Not stated
- Selection and preparation of corneas: Not stated
- Quality check of the isolated corneas: Examination under slit-lamp microscope (Haag-Streit BP900 with a slit width of 0.095mm)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (weight): 30 mg
- Concentration (if solution): NA
VEHICLE
- Amount(s) applied (volume or weight with unit): NA
- Concentration (if solution): NA
- Lot/batch no. (if required): NA
- Purity: NA - Duration of treatment / exposure:
- 10 second exposure
- Duration of post- treatment incubation (in vitro):
- 30, 75, 120, 180 and 240 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES: The selection of eyes was based on the cornea integrity following excision.
NUMBER OF REPLICATES: 3 replicates
NEGATIVE CONTROL USED: Physiological saline – Dutscher Batch No. C0543A01 – CAS : 7647-14-5 – EC: 231-598-3 – SMILES: [Na+].[Cl-] – Storage : room temperature
POSITIVE CONTROL USED: sodium hydroxide – Fisher Scientific, Batch No. 0000080257 - CAS : 1310-73-2 – EC: 215-185-5 – SMILES: [OH-].[Na+] – Storage : room temperature
APPLICATION DOSE AND EXPOSURE TIME: 30 mg of test material was used with 10s exposure time. XX was used for both control substances with 10 s exposure time
OBSERVATION PERIOD: NA
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: Two rinses with 10mL physiological saline followed by the use of a cotton bud soaked in saline to remove residual test material
- Indicate any deviation from test procedure in the Guideline: Use of cotton bud soaked with saline. However justification in the form of validated test methods does not deem this a deviation that affects the integrity of the test.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Haag-Streit BP900 slit-lamp microscope with depth-measuring device no. I. For the measurement of corneal thickness, the slit-width was set at 9½, equalling 0.095 mm
- Damage to epithelium based on fluorescein retention: NA
- Swelling: measured with optical pachymeter on a slit-lamp microscope; slit-width setting: Haag-Streit BP900 slit-lamp microscope with depth-measuring device no. I. For the measurement of corneal thickness, the slit-width was set at 9½, equalling 0.095 mm
- Macroscopic morphological damage to the surface: Not stated
- Others (e.g, histopathology): NA
SCORING SYSTEM: as per OECD TG 438
DECISION CRITERIA: as per OECD TG 438
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 45 minutes pretreatment, 30, 75, 120, 180 and 240 minutes post treatment
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- ICE class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 45 minutes pre-test and 30 minutes post treatment
- Value:
- >= 0.5 - <= 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- ICE Class III
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 45 minutes pre test, 30, 76, 120, 180 and 240 minutes post treatment
- Value:
- >= 0.5 - <= 0.62
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- ICE Class II
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 45 minutes pre test, 30, 76, 120, 180 and 240 minutes post treatment
- Value:
- >= 3 - <= 9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- ICE Class II
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none observed
DEMONSTRATION OF TECHNICAL PROFICIENCY: cf 'Attachment"
ACCEPTANCE OF RESULTS: cf. "'Attachments'
- Acceptance criteria met for negative control: The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, as expected the negative control is classified as “No Category”, as expected.
- Acceptance criteria met for positive control: The combination of the three endpoints for the positive control, Sodium Hydroxide 5%, was
3 x IV. Therefore, as predicted the positive control is classified as “Corrosive/Severe Irritant.
- Range of historical values if different from the ones specified in the test guideline: as per OECD TG 438. Cf. 'Attachment'
Any other information on results incl. tables
Table 2: Negative control - Assessment of the eye corrosion/severe irritation individual and average values for evaluation of corneal lesions after treatment
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 | 0.51 | 0.51 | 0.51 | 0.52 | 0.52 | 0.52 |
Corneal swelling (%) | 16 | - | 0 | 0 | 2 | 2 | 2 |
Mean | - | 0 | 0 | 2 | 2 | 2 | |
ICE class | I | ||||||
Combination of the 3 endpoints | 3 x I | ||||||
Classification | No Category |
Table 3: Positive control - Assessment of the eye corrosion/severe irritation individual and average values for evaluation of corneal lesions after treatment
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 | - | - | - | - | |
ICE class | IV | ||||||
Corneal thickness | 1 | 0.54 | 0.84 | 0.98 | 1.05 | 1.10 | 1.11 |
2 | 0.53 | 0.81 | 0.86 | 0.91 | 1.05 | 1.05 | |
3 | 0.56 | 0.82 | 0.87 | 0.89 | 1.03 | 1.12 | |
Corneal swelling (%) | 1 | - | 56 | 81 | 94 | 104 | 106 |
2 | - | 53 | 62 | 72 | 96 | 98 | |
3 | - | 46 | 55 | 59 | 84 | 100 | |
Mean | - | 52 | 66 | 75 | 95 | 101 | |
ICE class | IV | ||||||
Combination of the 3 endpoints | 3 x IV | ||||||
Classification | Category I: ‘Corrosive/Severe Irritant’ |
Table 4: Test item Curezol 2PHZ-PW - Assessment of the eye corrosion/severe irritation individual and average values for evaluation of corneal lesions after treatment
Endpoint measured | Eye no. | Time (min) | |||||
-45 | 30 | 75 | 120 | 180 | 240 | ||
Corneal opacity | 7 | 0 | 4 | 0 | 0 | 0 | 0 |
8 | 0 | 4 | 0 | 0 | 0 | 0 | |
9 | 0 | 4 | 0 | 0 | 0 | 0 | |
Mean | 0.0 | 0.0 | 4.0 | 0.0 | 0.0 | 0.0 | |
ICE class | I | ||||||
Fluorescein retention | 7 | 0.5 | 2 | - | - | - | - |
8 | 0.5 | 2 | - | - | - | - | |
9 | 0.5 | 2 | - | - | - | - | |
Mean | 0.5 | 2 | - | - | - | - | |
ICE class | III | ||||||
Corneal thickness | 7 | 0.58 | 0.59 | 0.59 | 0.59 | 0.62 | 0.62 |
8 | 0.50 | 0.53 | 0.53 | 0.53 | 0.57 | 0.59 | |
9 | 0.54 | 0.54 | 0.54 | 0.54 | 0.54 | 0.55 | |
Corneal swelling (%) | 7 | - | 2 | 2 | 2 | 7 | 7 |
8 | - | 6 | 6 | 6 | 14 | 18 | |
9 | - | 0 | 0 | 0 | 0 | 2 | |
Mean | - | 3 | 3 | 3 | 7 | 9 | |
ICE class | III | ||||||
Combination of the 3 endpoints | 1 x I 1 x II 1 x III | ||||||
Classification | No prediction can be made |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The combination of the three endpoints for the test item CUREZOL 2PHZ-PW was 1 x I, 1 x II, 1 x III. No prediction can be made.
- Executive summary:
In an in vitro eye irritation / corrosion study (Isolated Chicken Eye) performed according to the OECD TG No. 438 and in compliance with GLP, 30 mg of undiluted test item was applied to three enucleated chicken eyes for 10 seconds. The eyes were then rinsed twice with 10 mL of physiological saline. Following two rinses remnants of the product was still evident on the entire cornea of all three eyes. The remaining test substance was removed using a cotton bud soaked with physiological saline soaked. Three eyes were treated in the same manner with a positive control and one eye with a negative control. Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention 45 minutes prior the treatment and at 30, 75, 120, 180 and 240 minutes (± 5) minutes post treatment rinse.
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.0, corresponding to ICE class I;
- mean score of fluorescein retention: 2.0, corresponding to ICE class III;
- maximal mean corneal swelling: 9 %, corresponding to ICE class II.
The combination of the three endpoints for the test item CUREZOL 2PHZ-PW was 1 x I, 1 x II, 1 x III.
The combination of the three endpoints for the positive control, Sodium Hydroxide 5%, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438. Therefore, on prediction can be made on the test item CUREZOL 2PHZ-PW and additional testing is required to establish a definitive classification.
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.