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EC number: 291-813-1 | CAS number: 90480-76-5
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-04-27 to 2017-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- (adopted 29 July 2016)
- Deviations:
- yes
- Remarks:
- The coefficient of variation for the 10% v/v 60 minute exposure period was 30.6% with the acceptance criteria being 30%. This deviation was considered to have not affected the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[(5-amino-4-methylpentyl)amino]-3-(2-methylphenoxy)-propan-2-ol
- Cas Number:
- 1617528-43-4
- Molecular formula:
- C16H28N2O2
- IUPAC Name:
- 1-[(5-amino-4-methylpentyl)amino]-3-(2-methylphenoxy)-propan-2-ol
- Reference substance name:
- 1,1'-[(2-Methyl-1,5-pentanediyl)diimino]bis[3-(2-methylphenoxy)-propan-2-ol]
- Cas Number:
- 1617528-45-6
- Molecular formula:
- C26H40N2O4
- IUPAC Name:
- 1,1'-[(2-Methyl-1,5-pentanediyl)diimino]bis[3-(2-methylphenoxy)-propan-2-ol]
- Reference substance name:
- Mephenesin
- EC Number:
- 200-427-4
- EC Name:
- Mephenesin
- Cas Number:
- 59-47-2
- Molecular formula:
- C10H14O3
- IUPAC Name:
- 3-(2-methylphenoxy)propane-1,2-diol
- Reference substance name:
- 1,3-bis(2-methylphenoxy)propan-2-ol
- Cas Number:
- 17181-49-6
- Molecular formula:
- C17H20O3
- IUPAC Name:
- 1,3-bis(2-methylphenoxy)propan-2-ol
- Reference substance name:
- 2-methylpentane-1,5-diamine
- EC Number:
- 239-556-6
- EC Name:
- 2-methylpentane-1,5-diamine
- Cas Number:
- 15520-10-2
- Molecular formula:
- C6H16N2
- IUPAC Name:
- 2-methylpentane-1,5-diamine
- Reference substance name:
- 3,3’-(5-(2-hydroxy-3-(o-tolyloxy)propylamino)-4-methylpentylazanediyl)bis(1-(o-tolyloxy)propan-2-ol)
- Molecular formula:
- C36H52N2O6
- IUPAC Name:
- 3,3’-(5-(2-hydroxy-3-(o-tolyloxy)propylamino)-4-methylpentylazanediyl)bis(1-(o-tolyloxy)propan-2-ol)
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Solubility and stability of the test substance in the solvent/vehicle: The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a liquid: The test item was used as supplied and also prepared as 33% v/v and 10% v/v aqueous solutions.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- recommended by guideline
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- water for the 33% v/v and 10% v/v solutions
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 25810
- Production date:
- Shipping date:
- Delivery date: 03 May 2017
- Date of initiation of testing:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation (if applicable): 37 °C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Rinsing was achieved by filling and emptying each tissue under a constant soft stream of DPBS to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper and the tissue surface was swabbed. The rinsing procedure was then repeated once more to ensure the tissues were completely decontaminated.
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
- Barrier function:
- Morphology:
- Contamination:
- Reproducibility:
NUMBER OF REPLICATE TISSUES: duplicates
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues (if applicable): freeze killed
- N. of replicates : duplicates
- Method of calculation used: True viability = mean OD tvt-(OD tkt-OD ukt)
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL
- Concentration (if solution): neat, 33% v/v and 10% v/v aqueous solutions
NEGATIVE CONTROL
- Sterile distilled water
- Amount(s) applied (volume or weight): 50 μL
POSITIVE CONTROL
- Potassium Hydroxide
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- 3-Minutes and 60-Minutes
- Duration of post-treatment incubation (if applicable):
- The plates stood overnight at room temperature, to allow MTT extraction to proceed
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- neat test item
- Run / experiment:
- 3 minutes exposure period
- Value:
- 59.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 4.0% tissue viability
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure period
- Value:
- 31.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.9% tissue viability
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes; The test item was shown to directly reduce MTT and freeze-killed tissues were employed, the results of the MTT assay were therefore corrected as follows: True viability = mean OD tvt-(OD tkt-OD ukt)
- Colour interference with MTT: test item did not have the potential to cause color interference
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group were satisfied with the exception that the 10% v/v concentration of the test item after a 60 minute exposure period was borderline, this is reported as a deviation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- All three concentrations of the test item, 10%, 33% and neat, were considered to be non-corrosive to the skin.
- Executive summary:
In a skin corrosion study performed in accordance with OECD Guideline 431 (In Vitro Skin Corrosion) (adopted July 29, 2016), CGE-PMDA adduct (100%, 33% and 10% a.i.) was applied to the three-dimensional human epidermis model tissue for an exposure period of 3 and 60 minutes respecitvely in triplicates.
Each approximately 50 µL of the test item were applied to the tissues. After 3 or 60 minutes exposure at room temperature (3 min) or 37°C (60 min exposure time), the tissues were washed with phosphate buffered saline to remove any residual test material. Subsequently the tissue constructs were incubated for 3 h at 37°C. Cytotoxicity (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The positive (8.0 N KOH) and negative (deionised water) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after treatment with neat CGE-PMDA adduct compared to the negative control tissues was 59.7% for the 3 minute exposure period and 31.1% for the 60 minute exposure period. The relative mean tissue viability obtained after treatment with 33% CGE-PMDA adduct compared to the negative control tissues was 75.3% for the 3 minute exposure period and 15.8% for the 60 minute exposure period. The relative mean tissue viability obtained after treatment with 10% CGE-PMDA adduct compared to the negative control tissues was 94.4% for the 3 minute exposure period and 39.2% for the 60 minute exposure period.
Since the mean relative tissue viability for the neat test substance and both dilutions was ≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure, the prediction to be considered according to EU CLP Regulation (EC) No 1272/2008 is non-corrosive.
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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