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Diss Factsheets
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EC number: 271-766-3 | CAS number: 68607-67-0
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 mins - 42 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study to GLP, 2017
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Lot number HMK/370/12/1
Storage conditions Room temperature (15 – 25°C)
Purity/Assay Active >98%
Appearance Straw to Yellow Clear Bright Liquid - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 μL undiluted liquid
- Duration of treatment / exposure:
- 15 minutes exposure
- Duration of post-treatment incubation (if applicable):
- 42 hours followed by MTT exposure of 3 hours.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- > 9.2 - < 10.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Positive control was in the range of 8.2 - 14.3 and considered valid.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Considered irritting to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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:
- guideline study
- Justification for type of information:
- Guideline study to GLP, 2017
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Lot number: HMK/370/12/1
Storage conditions: Room temperature (15 – 25°C)
Purity/Assay: Active >98%
Appearance: Straw to Yellow Clear Bright Liquid - Species:
- cattle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- ca. 20.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The positive control, ethanol, elicited an In Vitro Irritancy Score of 40.2.
The negative control, 0.9% sodium chloride solution, opacity mean change value was 1.7 - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Although the result concludes that the irritancy cannot be predicted, the substance caused a degree of corneal opacity with a score of ca 20 and significantly over the limit score of 3 for non-classified.
In view of this indication of some eye irritation, classification as Eye Irrit 2 is proposed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The results of the in vitro tests performed with formaldehyde, reaction products with ethylendiamine show neither corrosive nor irritation properties related to the test item. The ex vivo study performed to evaluate the irritation potential of the tet substance to the eyes, showed a moderate irritating potential.
Justification for selection of skin irritation / corrosion endpoint:
As in the skin corrosion study formaldehyde, reaction products with ethylendiamine resulted non corrosive, a skin irritation study has been carried out. Also this study gave negative results and therefore it has been choosen as endpoint selection study.
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
According to the results of the available studies, formaldehyde, reaction products with ethylendiamine is classified as follows, according to Regulation 1272/2008/EC:
Eye Irrit. 2, H319.
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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