Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-147-9 | CAS number: 10563-26-5
- 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-10-23 - 2007-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (limit dose at 200 mg/kg bw)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- yes
- Remarks:
- limit dose at 200 mg/kg bw
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N'-bis(3-aminopropyl)ethylenediamine
- EC Number:
- 234-147-9
- EC Name:
- N,N'-bis(3-aminopropyl)ethylenediamine
- Cas Number:
- 10563-26-5
- Molecular formula:
- C8H22N4
- IUPAC Name:
- (3-aminopropyl)({2-[(3-aminopropyl)amino]ethyl})amine
- Details on test material:
- - Name of test material (as cited in study report): N4 Amine
- Physical state: clear liquid
- Analytical purity: 83.4% Bis-APEDA, 12.2% APEDA, 4.4% Tri-APEDA
- Lot/batch No.: 21000-15-1
- Storage condition of test material: room temperature and humidity
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: from Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: not specified
- Weight at study initiation: 2.1 – 2.4 kg for males and females (Table 1)
- Fasting period before study: approx. 90 days
- Housing: 1/cage in suspended wire cages
- Diet: Fresh PMI Rabbit Chow (Diet #5321); ad libitum
- Water: drinking water; ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, and was kept clean and vermin free.
No further details provided
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2007-11-01 To: 2007-11-15
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk of each animal clipped free of hair
- % coverage: approximately 10% of the body surface
- Type of wrap if used: the test substance was applied a 4-ply porous dressing (10 cm x 15 cm) and wrapped with plastic in a semi-occlusive manner and was secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was removed by gently washing with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 200 mg/kg bw
- No. of animals per sex per dose:
- 2 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed 1, 2 and 4 hours post-dose and once dose daily for toxicity and pharmacological effects, and twice daily for mortality. Body weights were recorded pretest, weekly and at termination.
- Necropsy of survivors performed: yes; all animals were humanely sacrificed using CO2 following study termination and examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination.
- Other examinations performed: clinical signs, body weight, organ weights.
The test sites were scored for dermal irritation at 24 hours post-dose and on days 11 and 14 using the numerical Draize scoring system. The skin was also evaluated evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described. - Statistics:
- An estimate of the LD50 was made based on the mortality during the study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality or adverse systemic effects were observed at this unique dose level.
- Mortality:
- All animals survived the 200 mg/kg bw dermal application.
- Clinical signs:
- other: One animal appeared lethargic on the day of treatment (Day 0). There were no abnormal clinical signs noted during the observation period.
- Gross pathology:
- Necropsy results revealed abnormalities of the treated skin. No further effects were noted.
- Other findings:
- Dermal effects were severe at the 24 hours and on days 11 and 14 (Table 2).
Any other information on results incl. tables
Table 1: Body weights
Animal number |
Sex |
Body weight (kg) |
||
Day 0 |
Day 7 |
Day 14 |
||
H505 |
Male |
2.5 |
2.6 |
2.7 |
H507 |
Male |
2.4 |
2.6 |
2.8 |
H529 |
Female |
2.9 |
2.9 |
3.0 |
H534 |
Female |
3.0 |
3.0 |
3.2 |
H533 |
Female |
2.2 |
2.4 |
2.6 |
Table 2: Dermal observations at indicated time points
Animal number |
24 hours |
Day 11 |
Day 14 |
% remaining 24 hours |
|||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
H506 |
>4n,b |
3 |
>4n |
1 |
>4n |
1 |
50% |
H508 |
>4n,b,p |
3 |
>4n,f |
2 |
>4n,s |
2 |
50% |
H509 |
>4n,b,p |
3 |
>4n,f |
2 |
>4n,f |
2 |
50% |
H530 |
>4n,b |
3 |
>4n |
2 |
>4n |
1 |
50% |
H533 |
>4n,b,p |
3 |
>4n,f |
1 |
>4n |
1 |
50% |
% remaining = a visual estimate of the amount of material on the skin and gauze at 24 hours, after the wrapping was removed; b = brown areas; f = flaking skin; p = pale areas; s = shiny areas; >4n = necrosis. |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
