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Diss Factsheets
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EC number: 939-056-4 | CAS number: 1469982-95-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fixapret PC, vor Magnesiumchlorid-Zugabe
- IUPAC Name:
- Fixapret PC, vor Magnesiumchlorid-Zugabe
- Details on test material:
- - Name of test material (as cited in study report): Fixapret PC, vor Magnesiumchlorid-Zugabe
- Physical state: liquid
- Analytical purity: Reaction product of urea, formaldehyde, glyoxal and diethylene glycol, content: 62.1 % in water
- Impurities (identity and concentrations): 37.9 % water (solvent)
- Lot/batch No.: 153
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor,
and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature; avoid temperatures < 5°C >30°C
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not applicable: in vitro study
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 750µl of undiluted test substance
- Duration of treatment / exposure:
- 10 min incubation time
- Observation period (in vivo):
- 2-hours post-incubation period
- Number of animals or in vitro replicates:
- 8 corneas (3 test substance, 3 negative control, 2 positive control)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: in vitro irritation score (IVIS), test substance
- Basis:
- mean
- Time point:
- other: 2 hours
- Score:
- -4.6
- Remarks on result:
- other: IVIS > 55: risk of serious damage to the eyes; IVIS < 55: no risk of serious eye damage
- Irritation parameter:
- other: in vitro irritation score (IVIS), negative control
- Basis:
- mean
- Time point:
- other: 2 hours
- Score:
- 4.5
- Remarks on result:
- other: the negative control gave the expected result (IVIS < 55)
- Irritation parameter:
- other: in vitro irritation score (IVIS), positive control
- Basis:
- mean
- Time point:
- other: 2 hours
- Score:
- 130.1
- Remarks on result:
- other: the positive control gave the expected result (IVIS > 55)
Any other information on results incl. tables
The BCOP test showed the following results:
Testsubstance
|
Mean Opacity Value
|
Mean Permeability Value
|
In Vitro Irritancy Score |
11/0428-1 |
-4.5 |
-0.007 |
-4.6 |
NC |
4.6 |
-0.006 |
4.5 |
PC * |
88.3 |
2.784 |
130.1 |
* Values based on two corneas
In Vitro Irritancy Score |
Prediction |
> 55 |
risk of serious damage to the eyes |
≤ 55 |
no risk of serious damage to the eyes |
Based on the observed results it was concluded, that Fixapret PC, vor Magnesiumchlorid-Zugabe does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.
Applicant's summary and conclusion
- Interpretation of results:
- other: no serious eye damage
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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