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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
oral (similar to OECD 401, rat, RL2): LD50 = 3221 mg/kg bw
dermal (similar to OECD 402, rabbit, RL2): LD50 = 1260 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974-1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- The study was performed pre-GLP and pre-guideline. Limited reporting. No information on the composition or purity of the test substance.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 5 non-fasted animals per group were dosed by a single gavage application. Observation period was 14 days.
- GLP compliance:
- no
- Remarks:
- Before GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: stated to be 3 -4 weeks old
- Weight at study initiation: stated to be 90 -120 g - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2.0, 4.0 and 8.0 mL/kg
The values were converted based on the given relative density of 0.991 - 0.9994. The following doses were calculated based on the lowest relative density value: 1982, 3964 and 7928 mg/kg bw. - No. of animals per sex per dose:
- 5 males/dose
- Control animals:
- no
- Details on study design:
- No details available
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3.25 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.36 - <= 4.47
- Remarks on result:
- other: LD50 calculated by the moving average method; LD50 = 3.25 mL/kg bw corresponds to 3221 mg/kg bw.
- Mortality:
- 0/5, 4/5 and 5/5 at 2, 4 and 8 mL/kg bw, respectively.
- Clinical signs:
- other: - 2 mL/kg bw: no signs - 4 mL/kg bw: slightly sluggish 6 min, prostrate 2 h, death 2 -3 h - 8 mL/kg bw: sluggish 2 min, prostrate 30 min, death 2 -3 h
- Gross pathology:
- - lungs with petechiae, liver and spleens mottled, stomachs liquid-filled and red, intestines distended and liquid-filled and red or slightly yellow, dark kidneys, bladders fluid-filled (in victims)
- livers mottled (in survivors) - Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Because of the LD50 value of 3221 mg/kg bw the test material is not considered to be harmful.
- Executive summary:
Five male rats per group were dosed by intubation with the undiluted test substance. Three groups were used; dose levels were 2.0, 4.0 and 8.0 mL/kg bw. 0/5, 4/5 and 5/5 of the animals died, respectively. The LD50 was calculated to be 3.25 mL/kg bw (3221 mg/kg bw) with 95% confidence limits of 2.36 and 4.47 mL/kg bw. , indicating classification in OECD-GHS category V.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 221 mg/kg bw
- Quality of whole database:
- The study was performed pre-GLP and pre-guideline, and has Klimisch score 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974-1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Short summary of acute dermal toxicity study, no GLP, no data on the composition of the test substance
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Rabbits were dosed using covered dermal application
- GLP compliance:
- no
- Remarks:
- Before GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24-h contact with the test substance retained under impervious (polyethylene) sheeting on the clipped intact skin of the trunk.
- Doses:
- 1.0, 2.0 and 4.0 mL/kg bw
- No. of animals per sex per dose:
- 4 males at 1.0 and 2.0 mL/kg bw, 2 males at 4.0 mL/kg bw
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.26 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.772 - <= 2.06
- Remarks on result:
- other: LD50 calculated by the moving average method; 1.26 mL corresponds to about 1260 mg
- Mortality:
- 1/4, 4/4 and 2/2 at 1.0, 2.0 and 4.0 mL/kg bw, respectively
- Clinical signs:
- other: - 1.0 mL/kg bw: necrosis - 2.0 mL/kg bw: necrosis, prostate at 1 day - 4.0 mL/kg bw: necrosis
- Gross pathology:
- lungs and kidneys reddened in victims, no abnormalties in survivors
- Interpretation of results:
- other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008
- Conclusions:
- Based on a LD50 value of 1.26 mL/kg bw which corresponds to about 1260 mg/kg bw, the test substance should be classified in Cat. 4 according to OECD-GHS
- Executive summary:
Two to four male rabbits per group were dosed by a 24 -h dermal application under occlusive conditions with the undiluted test substance. Three groups were used; dose levels were 1.0, 2.0, and 4.0 mL/kg bw. 1/4, 4/4 and 2/2 of the animals died, respectively. The LD50 was calculated to be 1.26 mL/kg bw with 95% confidence limits of 0.772 and 2.06 mL/kg bw, indicating classification in CLP/EU GHS Category 4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 260 mg/kg bw
- Quality of whole database:
- The study was performed pre-GLP and pre-guideline, and has Klimisch score 2.
Additional information
Oral toxicity:
An acute oral toxicity study with Amines, polyethylenepoly-, tetraethylenepentamine fraction was carried out in male Wistar rats (Myers, 1979, reliability 2). The study was performed before GLP and guidelines were set in place. Groups of 5 rats were treated via gavage of 2000, 4000 or 8000 mL/kg bw of the test substance and were observed for 14 days thereafter. The mortality rate was 0, 80 and 100%, respectively. Dying animals were sluggish and protstrate. The animals in the low dose group showed no signs of toxicity. Gross pathology revealed lungs with petechiae, liver and spleens mottled, stomachs liquid-filled and red, intestines distended and liquid-filled and red or slightly yellow, dark kidneys and bladders fluid-filled. The survivors showed mottled livers. The acute oral LD50 for males, was determined to be 3250 (2360 - 4470) mL/kg bw. This corresponds to about 3221 mg/kg bw.
One supporting study performed in female rats with only limited information resulted in a LD50 of 2140 mg/kg bw (Dow, 1964). Further supporting information is given in a secondary literature in which a LD50 of 2100 mg/kg bw for Amines, polyethylenepoly-, tetraethylenepentamine fraction is described (Spitz, 1979).
Taking all data together, Amines, polyethylenepoly-, tetraethylenepentamine fraction is considered to be of low acute toxicity.
Dermal toxicity:
An acute dermal toxicity study with Amines, polyethylenepoly-, tetraethylenepentamine fraction which is pre-GLP and similar to OECD guideline 402, with male New Zealand White rabbits, is available and has been used as a key study (Myers, 1979, reliability 2). Groups of 4 or 2 rabbits were treated for 24 hours under occlusive conditions at 1000, 2000, or 4000 mg/kg bw. Mortality was 25, 100, and 100%, respectively. Necrosis was observed in all animals. Necropsy of the animals that died during the study revealed reddened lungs and kidneys. Terminal necropsy revealed no abnormalities. Based on the observations made in this study, the acute dermal LD50 in males for the test substance was determined to be 1260 (772 - 2060) mg/kg bw.
Inhalation:
One old inhalation study is available in which rats had been exposed to the vapour of the registration substance generated at 22°C (Myers, 1979). No mortality occurred. The concentration has not been measured. A static test atmosphere generated as a vapour over a 16-h period was not toxic to rats. From a toxicologists point of view it is therefore doubtful if the animals were exposed to the test substance by inhalation and which concentration the generated vapour was of because the vapour pressure of the test substance is very low (0.0189 Pa at 20°C) which would result in a vapour saturation of 1.47 mg/m³. This is the maximum concentration which the animals were probably exposed to. This is far below the the concentration level which is needed for classification. Since the substance is classified as corrosive to skin no further acute inhalation toxicity test is required according to Reach Regulation Annex VIII point 8.5.
Justification for classification or non-classification
The available data on acute oral toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
The available data on acute dermal toxicity meet the criteria for classification according to Regulation (EC) 1272/2008, and is therefore classified as acute toxic Category 4 (H312).
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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