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EC number: 800-362-7 | CAS number: 1307863-78-0
- 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:
- Aug 08, 1984 - Aug 22, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reasonably wel reported and performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- EPA GLP regulations of 29 Dec 1983
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(tallow alkyl )-1,3,propanediamine oleates
- IUPAC Name:
- N-(tallow alkyl )-1,3,propanediamine oleates
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- Name: Duomeen TDO (AkzoNobel tradename for N-(tallow alkyl )-1,3,propanediamine oleates)
Batch: Lot #1400407
Common name:
Aspect: Tan Waxy Semi-Solid
pH: 4.5 @ 44°C
Specific Gravity: 0.87 @ 44°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: male and non-pregnant and nulliparous female Wistar Ablino rats, approximately 8 weeks old
- Weight at study initiation: between 200-300 grams,
- Fasting period before study: 16-20 hours prior to dosing.
- Housing: housed 5/sex/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): not stated
(temperature and humidity controlled)
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Aug 08, 1984 To: Aug 22, 1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- syringe and dosing needle at a dose level of 5.0 g/kg - no vehicle.
Sample preparation: 20 g of test article was heated gently to a melting point of 44°C - Doses:
- Single dose 5.0 g/kg
- No. of animals per sex per dose:
- 5 male + 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 hours post dose and once each morning and afternoon thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. Abnormal tissues were preserved in 10% buffered formalin for possible future microscpic examination. - Statistics:
- Not required for single dose: The LD 50 was considered to be greater than 5.0 g/kg if there was no compound related mortal ity at the 5.0 g/kg level.
Results and discussion
- Preliminary study:
- No
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 3/10 animals died at 5000 mg
- Mortality:
- 3 females on observation days 7, 8 and 12 respectively.
- Clinical signs:
- other: Yes - see table under other information
- Gross pathology:
- Yes - see table under other information
Any other information on results incl. tables
Clinical signs (duration average number of days)
|
Males |
Females |
|
|
|
Death |
Sarcrifice |
Number treated |
5 |
3 |
2 |
Diarrhea |
1(1) |
3(5) |
2(4) |
Piloerection |
1(1) |
3(3) |
|
Ptosis |
1(1) |
2(2) |
|
Emaciation |
1(1) |
1(1) |
|
Lethargy |
|
2(1) |
|
Anogenital area stained brown |
2(6) |
3(7) |
2(11) |
Nose/mouth stained brown |
|
3(6) |
2(8) |
Body surfaces soiled |
1(2) |
|
|
Necropsy observations
|
Males |
Females |
|
|
|
Death |
Sarcrifice |
Number necropsied |
5 |
3 |
2 |
Normal |
|
|
2 |
Cannibalized |
|
2 |
|
Anogenital area stained brown |
|
1 |
|
Lungs congested |
|
1 |
|
Stomach areas red |
|
1 |
|
Stomach distended with fluid |
|
1 |
2(11) |
Intestines red |
|
1 |
2(8) |
Intestines distended with fluid |
|
1 |
|
Body weights:
Animal-sex |
Dose vol. |
Day 0 |
Day 7 |
Day 14 |
1-M |
1.2 |
216 |
246 |
330 |
2-M |
1.3 |
219 |
242 |
328 |
3-M |
1.3 |
218 |
184 |
290 |
4-M |
1.4 |
247 |
300 |
384 |
5-M |
1.3 |
224 |
242 |
332 |
Mean |
224.8 |
242.8 |
332.8 |
|
S.D. |
12.8 |
41.1 |
33.5 |
|
6-F |
1.2 |
209 |
188 |
234 |
7-F |
1.5 |
253 |
270 |
322 |
8-F |
1.3 |
218 |
202 |
dead d.12 (144 g) |
9-F |
1.3 |
218 |
164 |
dead d.8* |
10-F |
1.2 |
211 |
dead d.7* |
|
Mean |
221.8 |
206 |
278 |
|
S.D. |
17.9 |
45.5 |
62.2 |
*Termina1 body weight was not recorded since the animals were cannibalized.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute oral toxicity was determined in a limit test in 5 males and 5 females at 5 g/kg bw, undilted. LD50 > 5.0 g/kg bw for males and females combined.
- Executive summary:
Method: Five healthy male and five healthy non-pregnant and nulliparous female albino rats were dosed orally with Duomeen TDO, Lot #1400407 at 5.0 g/kg of body weight.
The rats were observed 1, 2 and 4 hours post dose and twice daily for 14 days for mortality and toxicity. Body weights were recorded pretest, weekly, at death and at termination in the survivors. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
Although there was compound related mortality, a multi-dose LD50 was not performed as per client request.
Results: Seven of ten animals survived the 5.0 g/kg oral dose.
Three females died between Day 7 and Day 12 with pre-death physical signs of diarrhea, lethargy, ptosis, piloerection, emaciation, soiling of body surfaces and brown staining of the nose/mouth and anogenital areas. Two animals which died were not necropsied since they had been cannibalized. The other death had abnormalities of the lungs and gastrointestinal tract, as well as brown staining of the anogenital area. Physical signs of chromorhinorrhea, diarrhea, piloerection, emaciation, ptosis, soiling of body surfaces, and brown staining of the nose/mouth and anogenital areas were noted in survivors and were more prevalent in females.
Body weight increases were normal in 5/7 survivors. One male and one female lost weight during the first week of the study.
Necropsy results were normal in survivors.
Conclusion: The LD 50 is greater than 5.0 g/kg in males, less than 5.0 g/kg in females and greater than 5.0 g/kg for combined sexes.
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