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Diss Factsheets
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EC number: 700-570-7 | CAS number: 1217271-49-2
- 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:
- 2011-08-11 to 2011-10-17
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23 July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Version 439, 22 July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (6-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}hexyl)({2-methyl-2-[(morpholin-4-yl)methyl]propylidene})amine
- EC Number:
- 700-570-7
- Cas Number:
- 1217271-49-2
- Molecular formula:
- C24H46N4O2
- IUPAC Name:
- (6-{[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}hexyl)({2-methyl-2-[(morpholin-4-yl)methyl]propylidene})amine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- other: no animal testing
- Details on test animals or test system and environmental conditions:
- NA
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- NA
- Duration of treatment / exposure:
- NA
- Observation period:
- NA
- Number of animals:
- NA
- Details on study design:
- NA
Results and discussion
In vitro
Results
- Remarks on result:
- other:
- Remarks:
- Remarks: Sika Hardener MH is considered as “irritant in the Human Skin Model Test”. . (migrated information)
In vivo
- Irritant / corrosive response data:
- After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.
Any other information on results incl. tables
Findings and Results:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with Sika Hardener MH for 60 minutes.
30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier).
DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).
After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The determination of the skin irritation potential of Sika Hardener MH was performed in the Human Skin Model Test following Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23 July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test” and according to OECD Guideline for the Testing of Chemicals, Version 439, 22 July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with Sika Hardener MH for 60 minutes.
30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm²; as indicated by supplier).
DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18 %).
After the treatment with the test item, the relative absorbance values were reduced to 6.7 %. This value is well below the threshold for irritation potential (50%). Therefore, Sika Hardener MH is considered as “irritant in the Human Skin Model Test”.
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