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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-May 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Purity of a.i. has been indicated; complete composition of the test substance is not available (available in departmental study file).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- 20 instead of 21 days of exposure, occlusive dressing
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Amines, polyethylenepoly-, tetraethylenepentamine fraction
- EC Number:
- 292-587-7
- EC Name:
- Amines, polyethylenepoly-, tetraethylenepentamine fraction
- Cas Number:
- 90640-66-7
- Molecular formula:
- C8H23N5, C10H25N5
- IUPAC Name:
- (2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; bis(2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX, USA
- Age at study initiation: ca. 5 months
- Weight at study initiation: ca. 3.1 - 4.0 kg
- Fasting period before study: not applicable
- Housing: individually in stainless steel cages
- Diet: restricted to 4 oz per animal per day
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 5 degr F (22 ± 1.5 degr C)
- Humidity (%): 50
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: 10 x 15 cm
- % coverage: 100
- Type of wrap if used: an occlusive bandage of absorbent gauze and non-absorbent cotton; the bandage was held in place using a lycra/spandex jacket
- Time intervals for shavings or clipplings: periodically as required
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: ca. 6 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a 10% solution was applied with the volume adjusted to provide the required dose
- Concentration (if solution): 10%
- Constant volume or concentration used: yes, constant concentration
VEHICLE
- Justification for use and choice of vehicle (if other than water): water
- Amount(s) applied (volume or weight with unit): 1 mL/kg BW
USE OF RESTRAINERS FOR PREVENTING INGESTION: no (but animals wore jackets) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test material concentration (100 mg/g) was measured 3 times during the study in triplo. % of target concentrations were 87.0, 95.3 and 90.9%, respectively. Stability was measured 2, 4 and 7 days after preparation. % of Day 0 was, 92.1, 59.4 and 59.9%, respectively.
- Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- 5 days/week, ca. 6h/day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a probe study using 2 female rabbits per group, at levels of 0, 50, 100 or 200 mg/kg bw/day for 4 days
- Rationale for animal assignment (if not random): computer-generated tables of random numbers
- Rationale for selecting satellite groups: not used
- Post-exposure recovery period in satellite groups: not used
- Section schedule rationale (if not random): no info - Positive control:
- not used
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily on working days (one additional routine monitoring on these days and on weekend and holidays for dead animals and check for water and food availability)
DETAILED CLINICAL OBSERVATIONS: No
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily upon removal when bandage and jacket were removed.
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Since the animals were maintained on a restricted diet and normally ate all their ration, measurement of food consumption was not doen. Qualitative changes in consumption were monitored by a periodic visual check.
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: not applicable
HAEMATOLOGY: Yes
- Time schedule for collection of blood: immediately prior to necropsy
- Anaesthetic used for blood collection: Yes (no info which was used)
- Animals fasted: No
- How many animals: all
- Parameters examined: RBC, WPC, platelet count, haemoglobin, packed cell volume
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: immediately prior to necropsy
- Animals fasted: No
- How many animals: all
- Parameters examined: blood urea nitrogen, ALP, ALAT, glucose, total protein, albumin, Cl, Na, K, globulin (calculated)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (including eyes)
HISTOPATHOLOGY: Yes (complete set) of control and high dose animals; skin (application site and a non-treated section), liver kidneys and gross pathologic lesions were aslo examined from low and mid dose animals
Organ weights: brain, liver, kidneys, adrenals, ovaries, testes - Other examinations:
- None
- Statistics:
- Yes, for body weights, organ weights, clinical chemistry, haematology.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: one control female was removed from the study on day 14 because of a broken back.
There were no signs other than local dermal effects. These were dose-related and consisted of red dermal test sites on days 1-2. By study Day 6, animals tretaed with 200 mg/kg bw showed very red and slightly swollen test sites; on Day 16 the skin of some of these females was severely irritated with some crusting and bleeding. Other animals of the 200 mg/kg bw group and those of the 100 mg/kg group had irritated skin that did not progress further.
BODY WEIGHT AND WEIGHT GAIN: no effects
FOOD CONSUMPTION: no effects
FOOD EFFICIENCY: not measured
WATER CONSUMPTION: not measured
OPHTHALMOSCOPIC EXAMINATION: not applicable
HAEMATOLOGY: no effects
CLINICAL CHEMISTRY: no effects
URINALYSIS: not measured
NEUROBEHAVIOUR: not measured
ORGAN WEIGHTS: no effects
GROSS PATHOLOGY: confined to the skin of the 100 and 200 mg/kg groups, characterised by multifocal areas of epidermal and dermal necrosis often covered with crusts comprised of dry serum and necrotic debris.
HISTOPATHOLOGY: NON-NEOPLASTIC
Only dose-related changes in the skin consisting of: multifocal necrosis of the epidermis with extension into the dermis, acanthotic and hyperkeratotic areas, underlying dermis had a subacute inflammatory response consisting of lymphocytes, macrophages and heterophils. Dermal arterioles contained marginated leukocytes, hair folicles showed keratinization. Grading of the skin lesions reflected the extent if the lesion and the degree of functional damage.
HISTOPATHOLOGY: NEOPLASTIC (not applicable)
HISTORICAL CONTROL DATA (not applicable)
OTHER FINDINGS: none
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 1.25 mg/cm² per day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- >= 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- haematology
- mortality
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
The NOAEL for the local effects is 50 mg/kg bw/day. Taking into account a mean body weight of this dose group of 3745 g and an exposed are of 150 cm² 50 mg/kg bw/day corresponds to about 1.25 mg/cm²/day.
Applicant's summary and conclusion
- Conclusions:
- At 100 and 200 mg/kg bw/day, the only lesions noted were skin lesions; the NOEL was 50 mg/kg bw/day.
- Executive summary:
Groups of 5 male and 5 female rabbits were treated on their skin with 50, 100 or 200 mg Amines, polyethylenepoly-, tetraethylenepentamine fraction per kg/bw ca. 6 h/day day, 5 days/week for a period of 31 days (under occlusive conditions). These levels were based on a 4 -day RF study using the same levels using 2 females per group. Controls were treated with the vehicle, distilled water. No changes were observed in body weights, food intake, haematology, clinical chemistry, and organ weights. The only lesions observed were local skin lesions; the degree of irritation was dose-related; effects in the 200 mg/kg group were generally more severe than in the 100 mg/kg group. There were no indications of systemic toxicity. Because no changes were seen in the 50 mg/kg group, the NOEL was 50 mg/kg bw/day.
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