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EC number: 428-190-4 | CAS number: 68490-66-4 CUREZOL 2MA-OK
- 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:
- key study
- Study period:
- 03 Aug 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- instead of the In Vitro Irritancy Score (IVIS) used in TG OECD 437, another scoring system was used: the Curren et al In Vitro Scores of up to 25 are classified as negative; scores greater than 25 are classified as positive potential eye irritants.
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron, P., Dukic, M., Alix, D. and Sina, J.F. (1992). Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam. Appl. Toxicol. 18:442-449.
- Principles of method if other than guideline:
- - Principle of test: The test followed the principles established by Gautheron, et al. (1992), the same as are incorporated into OECD TG number 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. The OECD TG was adopted 26 July 2013.
- Short description of test conditions: Briefly, two endpoints were measured in the assay, which used isolated bovine corneas obtained as a by-product from the meat production industry. These measurements were combined to give an In Vitro Score which was used to determine the potential eye irritancy of the test substance according to the Prediction Model developed by Curren, et al. (1996).
- Parameters analysed / observed: Corneal opacity and permeability.
Curren, R.D., Harbell, J.W., Raabe, H.A.,Sussman, R.G., and Kimmel, T.A. (1996). The utility of a two-test in vitro battery to assess the ocular irritancy of drug intermediates: Developments in Animal and Veterinary Sciences, 27. Proceedings of the 2nd World Congress on Alternatives and Animal use in the Life Sciences, Utrecht, 20-24 October 1996. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United kingdom, London, England.
Test material
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Local abattoir as a by-product from freshly slaughtered animals.
- Number of animals: no data
- Characteristics of donor animals: no data
- Storage, temperature and transport conditions of ocular tissue: Eyes were excised after slaughter and were transported on the same day (of slaughter), at ambient temperature, in Hank's Balanced Salt Solution (HBSS) supplemented with antibiotics.
- Time interval prior to initiating testing: Corneas were used within 4 hours of slaughter.
- indication of any existing defects or lesions in ocular tissue samples: The eyes were free of defects such as opacity, scratches, pigmentation, cuts, and neovascularization. Prior to testing, corneal opacity was determined by the amount of light transmitted through the cornea via a opacitometer.
- Indication of any antibiotics used: 1% (w/v) Penicillin/Streptomycin in HBSS.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL
- Concentration (if solution): 20% (w/v) solution in 0.9% (w/v) sodium chloride
VEHICLE
- Amount applied: 0.75 mL
- Concentration (if solution): 0.9% sodium chloride solution
- Lot/batch no.: Sigma, S8776 lot number 125K2365
- Purity: 0.9% - Duration of treatment / exposure:
- 240 minutes at 32 ± 1 °C
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: Sourced from a local abattoir as a by-product from freshly slaughtered animals.
QUALITY CHECK OF THE ISOLATED CORNEAS: The eyes were visually inspected to be free of defects such as opacity, scratches, pigmentation, cuts, and neovascularization. Prior to testing, corneal opacity was determined by the amount of light transmitted through the cornea via a opacitometer.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: 0.9% sodium chloride
POSITIVE CONTROL USED: Imidazole 20% (w/v) in 0.9% (w/v) sodium chloride
APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL for 240 minutes at 32 ± 1 °C
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: a post-treatment opacity was measured and each cornea was visually observed prior to incubation with sodium fluorescein [5 mg/mL in cMEM]
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490): after 90 minutes at 32 ± 1 °C
- Others: None
SCORING SYSTEM: In Vitro Score according to the Prediction Model developed by Curren, et al (1996).
DECISION CRITERIA: In Vitro Scores up to 25 are classified as negative and scores greater than 25 are classified as positive eye irritants.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean out of all 3 eyes
- Value:
- 3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: throughout the assay,the corneas were examined for opaque spots or other irregularities. The corneas treated with the test material were noted as clear with opaque spots. The corneas treated with the positive control, Imadazole, were very opaque. The negative control treated corneas were clear.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control gave opacity of 0.333 ± 2.309 and permeability of 0.003 ± 0.001, therefore acceptance criteria were satisfied.
- Acceptance criteria met for positive control: The positive control In Vitro Score was 119.3 ± 10.1, therefore the acceptance criteria were satisfied.
- Range of historical values if different from the ones specified in the test guideline: Positive Control, Imidazole assay validity acceptance range: 114.2 to 168.1.
Any other information on results incl. tables
Treatment |
Cornea number |
Opacity |
Permeability (OD) |
In Vitro Score |
||||
Pre-trmt |
Post-trmt |
Post – pre |
Corrected change |
|
Corrected |
|||
Negative Control |
1 |
5 |
4 |
-1 |
|
0.004 |
|
|
2 |
4 |
7 |
3 |
|
0.004 |
|
|
|
3 |
4 |
3 |
-1 |
|
0.002 |
|
|
|
Test Material |
7 |
5 |
11 |
6 |
5.667 |
0.006 |
0.003 |
5.707 |
8 |
4 |
8 |
4 |
3.667 |
0.002 |
-0.001 |
3.647 |
|
9 |
5 |
5 |
0 |
-0.333 |
0.002 |
-0.001 |
-0.353 |
|
Positive Control |
4 |
4 |
110 |
106 |
105.667 |
1.477 |
1.474 |
127.772 |
5 |
4 |
93 |
89 |
88.667 |
2.22 |
2.217 |
121.917 |
|
6 |
5 |
77 |
72 |
71.667 |
2.435 |
2.432 |
108.142 |
OD = optical density
trmt = treatment
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The test substance is a negative potential eye irritant.
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.
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