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EC number: 701-369-7 | CAS number: -
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5-30 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: other guideline: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, N-(3- aminopropyl)-N’-[3-(C18 and C18-unsatd. alkyl amino)propyl]trimethylenedi and amines, N-(3-aminopropyl)-N’-(C18 and C18-unsatd. alkyl)trimethylenedi-
- EC Number:
- 701-369-7
- Molecular formula:
- UVCB - No molecular formula;
- IUPAC Name:
- Amines, N-(3- aminopropyl)-N’-[3-(C18 and C18-unsatd. alkyl amino)propyl]trimethylenedi and amines, N-(3-aminopropyl)-N’-(C18 and C18-unsatd. alkyl)trimethylenedi-
- Reference substance name:
- (Z)-N-(3-aminopropyl)-N'-[3-(9-octadecenylamino)propyl]propane-1,3-diamine
- EC Number:
- 266-613-2
- EC Name:
- (Z)-N-(3-aminopropyl)-N'-[3-(9-octadecenylamino)propyl]propane-1,3-diamine
- Cas Number:
- 67228-83-5
- Molecular formula:
- C27H58N4
- IUPAC Name:
- N-[3-[3-[[(E)-octadec-9-enyl]amino]propylamino]propyl]propane-1,3-diamine
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Oleyl tripropylenetetramine
- Substance type: White paste (determined at NOTOX)
- Physical state: solid
- Analytical purity: 100% technical grade (UVCB)
- Impurities (identity and concentrations): See Certificate of Analysis
- Composition of test material, percentage of components: See Certificate of Analysis
- Purity test date: 5 Feb 2009
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark under nitrogen
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Substance as described in Chapter 1.1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 9-11 weeks old
- Weight at study initiation: 173-204 grams. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: yes, overnight prior to dosing and until 3-4 hours after administration of the test substance
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 – 21.0ºC
- Humidity (%): 40 - 79%
- Air changes (per hr): approx.15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 June 2009 To: 30 June 2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg/kg: 30 mg/mL, and 2000 mg/kg: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual):
The formulations (w/w) were prepared within 4 hours prior to dosing, and were flushed with nitrogen. Homogeneity was accomplished to a visually acceptable level. In order to obtain homogeneity, the test substance formulations were heated in a water bath with a maximum temperature of 50ºC for a maximum of 11 minutes. The test substance (formulations) were allowed to cool down to a temperature of maximally 40ºC prior to dosing. Adjustment was made for specific gravity of the vehicle and for density of the test substance. The concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on anticipated toxicity at 2000 mg/kg. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: two groups of 3 females
2000 mg/kg: one group of 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. Weighing: Days 1 (pre-administration), 8 and 15 and at death (if found dead after Day 1).
- Necropsy of survivors performed: yes
- Other examinations performed: none. - Statistics:
- Not applicable.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Mortality:
- The incidence of mortality was as follows, presented in chronological order of treatment:
Dose level Mortality Date of treatment
300 mg/kg 0/3 05 June 2009
300 mg/kg 0/3 09 June 2009
2000 mg/kg 2/3 16 June 2009
The decedents were found on day 2 post-treatment. - Clinical signs:
- other: Hunched posture, rales, salivation and/or piloerection were observed among all females at 300 mg/kg. Hunched posture, uncoordinated movements and piloerection were noted among all females at 2000 mg/kg. The surviving animals had recovered from the sympto
- Gross pathology:
- A beginning stage of autolysis was noted among the animals found dead at 2000 mg/kg.
No macroscopic abnormalities were noted among animals at 300 mg/kg, and in the surviving female at 2000 mg/kg. - Other findings:
- None.
Any other information on results incl. tables
None.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 value of Oleyl tripropylenetetramine in Wistar rats was established to be within the range of 300-2000 mg/kg body weight, with LD50 cut -off: 1000 mg/kg.
- Executive summary:
The incidence of mortality was as follows, presented in chronological order of treatment:
Dose level Mortality Date of treatment
300 mg/kg 0/3 05 June 2009
300 mg/kg 0/3 09 June 2009
2000 mg/kg 2/3 16 June 2009
The decedents were found on day 2 post-treatment.
Hunched posture, rales, salivation and/or piloerection were observed among all females at 300 mg/kg. Hunched posture, uncoordinated movements and piloerection were noted among all females at 2000 mg/kg.
The surviving animals had recovered from the symptoms between Days 3 and 5, except for animal no. 1 (300 mg/kg) showing rales up to scheduled necropsy.
Animals found dead at 2000 mg/kg showed slight body weight loss. The surviving female at 2000 mg/kg showed a slightly reduced body weight gain between days 1 and 8.
The body weight gain shown by the animals at 300 mg/kg over the study period was considered to be normal.
A beginning stage of autolysis was noted among the animals found dead at 2000 mg/kg.
No macroscopic abnormalities were noted among animals at 300 mg/kg, and in the surviving female at 2000 mg/kg.
The oral LD50value of Oleyl tripropylenetetramine in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
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