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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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, OECD 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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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
- Species:
- other: reconstructed human epidermis
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable: in vitro study
Test system
- Amount / concentration applied:
- single topical application of 30 μL of the test substance
- Duration of treatment / exposure:
- 1 hour treatment
- Observation period:
- 42-hours post-incubation period
- Number of animals:
- 9 EpiDerm™ Tissues (3 test substance, 3 negative control, 3 positive control)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: mean OD570, test substance
- Value:
- 1.939
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 hours. Remarks: viability of treated tissues = OD570 (test substance)/OD570(negative control). (migrated information)
- Irritation / corrosion parameter:
- other: other: mean OD570, negative control
- Value:
- 1.981
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 hours. (migrated information)
- Irritation / corrosion parameter:
- other: other: viability (% of negative control)
- Value:
- 98
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 hours. Max. score: 100.0. Remarks: viability <50% = irritant; >50% = non-irritant; the positive control included in the test design had the expected value . (migrated information)
Any other information on results incl. tables
The EpiDerm skin irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 98%. The viability was calculated by the ratio of the OD570 of the test substance and the OD570 of the negative control.
Mean tissue viability (% of negative control) |
Prediction |
≤ 50 |
irritant |
> 50 |
non-irritant |
Test substance |
|
mean |
Standard Deviation |
NC |
mean OD570
|
1.981 |
|
viability [% of NC] |
100 |
2.97 |
|
11/0428-1
|
mean OD570 |
1.939 |
|
viability [% of NC] |
98 |
3.96 |
|
PC |
mean OD570 |
0.108 |
|
viability [% of NC] |
5 |
0.42 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on the observed results it was concluded, that Fixapret PC, vor Magnesiumchlorid-Zugabe does not show a skin
irritation potential in the EpiDermTM skin irritation test under the test conditions chosen.
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