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EC number: 628-863-4 | CAS number: 1219458-14-6
- 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:
- 24 June 2009 - 14 July 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.
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: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 1219458-14-6
- Details on test material:
- - Chemial name: Triamine C16-18, C18-unsaturated
- EC Number: 628-863-4
To the best of knowledge, the sample used is representative to the boundary composition share and agreed by each registrant.
Constituent 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: 155-186 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 (%): 41 - 79%
- Air changes (per hr): approx.15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24 June 2009 To: 14 July 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 (except the 2000 mg/kg formulation; this was considered not to have adversely affected integrity of the test substance as the test substance itself was flushed with nitrogen and formulated in vehicle afterwards). 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 44ºC for at least 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:
- 2000 mg/kg: one group of 3 females
300 mg/kg: two groups 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 levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: OECD 423 Cut-off level
- 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 24 June 2009
300 mg/kg 0/3 30 June 2009
2000 mg/kg 3/3 02 July 2009
At 2000 mg/kg, animals were found dead or sacrificed in moribund condition on Days 2 or 3. - Clinical signs:
- other: Clinical signs observed during the study period were as follows: Dose level Clinical signs 300 mg/kg Hunched posture, piloerection, lethargy, chromodacryorrhoea on Days 1 and/or 2. 2000 mg/kg Hunched posture, piloerection, lethargy, ptosis.
- Gross pathology:
- An advanced stage of autolysis was noted for one animal at 2000 mg/kg found dead on Day 3.
No further abnormalities were found at macroscopic post mortem examination of the animals. - Other findings:
- None.
Any other information on results incl. tables
None.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS, EU 67/548/EEC and 1272/2008
- Conclusions:
- The oral LD50 value of Tallow dipropylenetriamine in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
OECD 423 LD50 cut-off value is 500 mg/kg body weight. - Executive summary:
All animals at 2000 mg/kg were found dead or were sacrificed moribund on Days 2 or 3. At 300 mg/kg, no mortality occurred.
Clinical signs observed during the study period were as follows:
Dose level Clinical signs
300 mg/kg Hunched posture, piloerection, lethargy, chromodacryorrhoea on Days 1 and/or 2.
2000 mg/kg Hunched posture, piloerection, lethargy, ptosis.
Slight body weight loss was noted for all animals at 2000 mg/kg prior to death.
The mean body weight gain shown by the animals at 300 mg/kg over the study period was considered to be normal.
An advanced stage of autolysis was noted for one animal at 2000 mg/kg found dead on Day 3.
No further abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50value of Tallow dipropylenetriamine 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 500 mg/kg body weight.
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