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EC number: 243-421-7 | CAS number: 19900-69-7
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- With the HET-Cam test an irritative or corrosive potential is determined by a detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs.
The Cam (chorioallantoic membrane) is a vital vascular membrane with a closed blood vessel system. After application of a test item on the membrane the underlying blood vessels could become damaged. Particularly three events are observed: haemorrhage, vessel lysis and coagulation of the blood in the vessels. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-methylenebis(2,6-diisopropylaniline)
- EC Number:
- 243-421-7
- EC Name:
- 4,4'-methylenebis(2,6-diisopropylaniline)
- Cas Number:
- 19900-69-7
- Molecular formula:
- C25 H38 N2
- IUPAC Name:
- 4-{[4-amino-3,5-bis(propan-2-yl)phenyl]methyl}-2,6-bis(propan-2-yl)aniline
- Reference substance name:
- Lonzacure M-DIPA
- IUPAC Name:
- Lonzacure M-DIPA
- Test material form:
- solid: compact
- Details on test material:
- - Identity: Lonzacure M-DIPA
- Molecular Weight: 366.6 g/mol
- Appearance: Solid, white to brown
- Solubility: In EtOH, acetone, acetonitrile, and DMSO > 1 g/L
- Stability in Solvent: In H2O, EtOH, acetone, acetonitrile, and DMSO > 96 hours
- Storage: At room temperature protected from light
- Expiration Date: December 31, 2009
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: chicken eggs.
- Strain:
- other: Lohmann Selected Leghorn
- Details on test animals or tissues and environmental conditions:
- The eggs were obtained from the LSL Rhein-Main Geflügelvermehrungsbetriebe (D-64807 Dieburg, Germany) on day one. Afterwards they were incubated at 37,5 ± 0.5 °C for eight days. The HET-Cam was carried out with Lohmann Selected Leghorn chicken eggs. The Lohmann Selected Leghorn chicken was selected for several reasons: the ability to hatch the eggs of this breed is very consistent and reproducible. There did not appear to be any hereditary defects in this breed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- In the HET-Cam assay the test item was tested pure. Six eggs were treated with the test item. An amount of the solid test item was applied to the membrane so that at least 25% of the membrane was covered by the test item
- Duration of treatment / exposure:
- An amount of the solid test item was applied to the membrane so that at least 25% of the membrane was covered by the test item. During the observation for 300 seconds lesions in close proximity to the covered membrane were noted.
- Observation period (in vivo):
- The membrane of the eggs were observed for 300 sec. Lesions of the underlying blood vessels were noted. In general there were three endpoints which were observed and the time when that particular endpoint was observed was noted. The three endpoints were:
• haemorrhage
• coagulation
• lysis of the blood vessel - Number of animals or in vitro replicates:
- Six eggs were treated with the test item.
- Details on study design:
- While incubation the eggs were rotated to prevent an attachment of the embryo to one side of the egg. On day eight the eggs were candled and non-viable eggs were discarded. The rest of the eggs were placed upward in the incubator and were incubated for another day without rotation. Six eggs were treated with the test item.
Physiological sodium chloride solution (0.9% (v/v)) was used as negative control. The negative control showed no irritating effect on the blood vessels under the membrane. An 1 % solution of SDS and 0.1 N NaOH were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 7.83 for 1% SDS and 19.66 for 0.1 N NaOH.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean irritancy index
- Run / experiment:
- mean of six experiments
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- It can be stated that in this study and under the experimental conditions reported, the test item does not possess any irritating potential.
- Executive summary:
This in vitro study was performed according to OECD 405 to assess the irritating potential of the test item by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs. The test item was tested pure. The observation time was 5 minutes at room temperature. No irritating effects were observed during 5 min incubation with the test item. The calculated mean irritancy index is 0.00.
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