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EC number: 700-714-9 | CAS number: 1254469-57-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25.2.2011-08.09.2011
- 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 431, OECD 439
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride
- EC Number:
- 700-714-9
- Cas Number:
- 1254469-57-2
- Molecular formula:
- C14H20ClN3O3
- IUPAC Name:
- 4-({N'-[(2-hydroxyphenyl)methylidene]hydrazinecarbonyl}methyl)-4-methylmorpholin-4-ium chloride
- Details on test material:
- - Name of test material (as cited in study report): Tinocat ES 96000
- Analytical purity: The test substance has been characterized analytically (for details see report No.: 11L00011)
- Lot/batch No.: RD173323
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this
responsibility
- Other: pH-value: Approx. 4 (undiluted test substance, moistened with water)
Constituent 1
Test animals
- Species:
- other: reconstructed human epidermal model
- Details on test animals or test system and environmental conditions:
- not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: water and PBS
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 μL bulk volume
- Concentration (if solution): about 11 mg - Duration of treatment / exposure:
- Corrosion test: 3 minutes and 1 hour
Irritation test: 1 hour - Observation period:
- Corrosion test: 0 hours
Irritation test: 42 hours - Number of animals:
- Corrosion test: 2 tissues
Irritation test: 3 tissues - Details on study design:
- not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: mean OD570 values (as measures of the viability) negative control
- Value:
- > 1 - < 2.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 min or 1 hour. Remarks: tissue viability: quotient of the mean OD570 divided by the respective OD570 NC value in percent; Corrosion test: Acceptance criteria for PC (viability ≤ 30%) reached; Irritation test: Acceptance criteria for PC (viability ≤ 20%) reached. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean OD570 values (as measures of the viability) test item; corrosion test
- Value:
- 92 - 98
- Remarks on result:
- other:
- Remarks:
- Basis: mean 2 tissues. Time point: 3 min or 1 hour. Remarks: Corrosion test: Mean tissue viability (% of negative control): 3 min: < 50 = corrosive; 3 min: ≥ 50 and 1 hour: < 15 = corrosive; 3 min: ≥ 50 and 1 hour: ≥ 15 = non-corrosive . (migrated information)
- Irritation / corrosion parameter:
- other: other: mean OD570 values (as measures of the viability) test item; irritation test
- Value:
- 32
- Remarks on result:
- other:
- Remarks:
- Basis: mean 3 tissues. Time point: 43 hours. Remarks: Irritation test: Mean tissue viability (% of negative control) ≤ 50 = irritant; > 50 = non-irritant . (migrated information)
Any other information on results incl. tables
Corrosion test data after 3 min
Test substance | Mean OD 570 | Viability [% of negative control] |
Negative control | 1.804 | 100 |
11/0013-1 | 1.761 | 98 |
Positive control | 0.368 | 20 |
Corrosion test data after 1 hour
Test substance | Mean OD 570 | Viability [% of negative control] |
Negative control | 1.68 | 100 |
11/0013-1 | 1.543 | 92 |
Positive control | 0.162 | 10 |
Irritation data
Test substance | Mean OD 570 | Viability [% of negative control] |
Negative control | 1.890 | 100 |
11/0013-1 | 0.603 | 32 |
Positive control | 0.123 | 7 |
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The potential of Tinocat ES 96000 to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 11 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiDerm™ skin corrosivity/irritation test showed the following results: The test substance is not able to reduce MTT directly. Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 98%, and it was 92% after an exposure period of 1 hour. Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 32%. Based on the observed results and applying the evaluation criteria cited in chapter 3.8 it was concluded, that Tinocat ES 96000 shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
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