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EC number: 292-587-7 | CAS number: 90640-66-7
- 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
Endpoint summary
Administrative data
Description of key information
Amines, polyethylenepoly-, tetraethylenepentamine fraction is corrosive.
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:
- unknown
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Review paper with many chemicals tested, therefore no specific details available
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Principles of method if other than guideline:
- This study was carried out for validation of the OECD 435 testing guideline.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- 100%
pH of 10% solution is 11.85
No further details given - Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes
- Components: dermal biobarrier and chemical detection system
- Apparatus and preparation procedures: not specified
WAS THE COMPATIBILITY TEST PERFORMED: yes
WAS THE TIMESCALE CATEGORY TEST PERFORMED: not specified
TEMPERATURE USED DURING TREATMENT: not specified
METHOD OF DETECTION
Chemical Detection System (CDS). The CDS consists of multiple chemical detectors which have demonstrated responsiveness with over 32 classes of chemicals.
METHOD OF APPLICATION: not specified
NUMBER OF REPLICATES: not specified
NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: not specified
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if a color change occured after 1 hour to 4 hours (Cat. 1C), after 3 minuntes and 1 hour (Cat. 1B) and in less than 3 minutes (Cat. 1A)
- The test substance is considered to be non-corrosive to skin if no color change occured after 4 hours
- Justification for the selection of the cut-off point(s): according to guideline - Control samples:
- other: evaluation for 75 chemicals and comparing to the in vivo data
- Amount/concentration applied:
- not specified
- Duration of treatment / exposure:
- until color change occurs
- Number of replicates:
- not specified
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 61
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- Test result of Tetraethylenepentamine (concentration neat, pH 11.85) showed a color change after 61 minutes (mean) without a standard deviation given
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H314) according to Regulation (EC) No 1272/2008
- Conclusions:
- Based on this in vitro test, Amines, polyethylenepoly-, tetraethylenepentamine fraction should be classified as corrosive Cat. 1B (DOT Packaging Group II).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
An in vitro skin irritation study is available with Amines, polyethylenepoly-, tetraethylenepentamine fraction (Gordon, 1994). This study was carried out for validation purposes of the OECD 435 testing guideline. The Corrositex ® test kit was used. Only a summary table is available. Amines, polyethylenepoly-, tetraethylenepentamine fraction was tested as neat substance. The test substance showed a full-thickness destruction of the biobarrier membrane after 1 hour and 1 minute. Based on the definition given in the publication this would lead to a Corrosive Packing Group III which is equivalent to CLP/EU Category 1C. It was however indicated that the standard deviation was “not done” which seems to mean that it was tested only once. With a possible variation of e.g. a few minutes for such a one hour period it can be speculated that Amines, polyethylenepoly-, tetraethylenepentamine fraction could be classified as borderline between Cat. 1B and 1C. Ethylenediamine (100%) showed a barrier breakthrough of 13 minutes with a standard deviation of 30 seconds, resulting in classification into PG II (CLP corrosion Cat. 1B). Amines, polyethylenepoly-, triethylenetetramine fraction showed a barrier breakthrough at 49 minutes (with a standard variation of 1.19 min) and as such should be classified in Cat. 1B. Although it was indicated that Amines, polyethylenepoly-, triethylenetetramine fraction was tested as a 60% concentration, but considering that breakthrough time seems to increase with increasing length of the ethylene amines (order EDA, TETA, TEPA), the results for 100% TETA can be expected also to fall into Cat. 1B. Considering the available data, classification in Cat. 1B seems most appropriate for Amines, polyethylenepoly-, tetraethylenepentamine fraction.
Two further skin irritation studies performed pre-GLP and pre-guideline with the registration substance are available (Myers, 1979 and Dow, 1965). The information on the study design is very limited and no detailed scores are reported. However, the test substance was applied to the bellies of rabbits. In one study 3 of 5 rabbits necrosis was observed (Myers, 1979) leading to the conclusion that the test substance is corrosive. In the second study the test substance led to crustations which healed without scars.
Based on the observed results the registration substance is considered to be corrosive to skin (Cat. 1B).
Eye irritation
Only limited data is available with Amines, polyethylenepoly-, tetraethylenepentamine fraction. Two eye irritation studies performed pre-GLP and pre-guideline with the registration substance indicate that the test substance might have eye damaging properties (Myers, 1979 and Dow, 1965). Since no information on the study design and no detailed scores are reported, those studies cannot be used for a final hazard conclusion. However, as described above Amines, polyethylenepoly-, tetraethylenepentamine fraction is considered to be corrosive to skin thus no further testing is required.
Justification for classification or non-classification
Reliable data with the registration substance on skin irritation indicate that the registered substance meets the criteria for classification according to Regulation (EC) No. 1272/2008. The test substance is therefore classified as corrosive to skin Cat. 1B (H314). As the registration substance is classified as corrosive to skin and thus leading to a classification as serious eye damage (Cat. 1, H318). No further testing on eye irritation is required.
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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