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EC number: 941-482-0 | CAS number: 1044764-08-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988-05-16 to 1988-06-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- February, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fettsauredimethylaminopropylamid
- IUPAC Name:
- Fettsauredimethylaminopropylamid
- Details on test material:
- - Name of test material (as cited in study report): FETTSAUREDIMETHYLAMINOPROPYLAMID
- Chemical name:
- Physical state: beige-coloured, waxy, squamous material
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: normal room temperature, in darkness
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8741 Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: males: 208 - 250 g, females: 160 - 190 g
- Fasting period before study: 16 h before until 4 h after administration of the test article
- Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet: ad libidum, standard laboratory rat diet Ssniff-R
- Water: ad libitum, aqua fontana as for human consumption
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-2 °C
- Humidity: 50-80 %
- Air changes (per hr): no data
- Photoperiod: fluorescent light (120 lux), 12 hours daily from 7.00 a.m. - 7.00 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 2500, 3000, 4000, and 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Preparation of the test compound: For treatment the sample was liquified at a temperature of about 45°C and then diluted with warm Oleum arachidis by using a magnetic stirrer. For dosing the dilution was cooled down to about 35°C. The following concentrations were used: .25%, 30% and 50%. The pH-value was 6.6.
- Duration of observation period following administration: 14 days
- Frequency of weighing: The body weights were recorded at day 0 (beginning of the experiment), at day 7 and at day 14 (terminal necropsy) on the surviving animals.
- Clinical observations: The evaluation of the clinical-toxicological signs (a modified Irvin-Screening by Screening methods in pharmacology, R. A. Turner, 1965) was done individually and depends on the nature of the signs. If the symptoms persist to the same degree for a longer period of time, this was noted in the corresponding protocols. Only a change of symptoms was recorded. Records were made according to the following intervals: about 20', 1 + 2 h, 3 + 6 h, 24 h, thereafter once daily up to day 14.
- Necropsy of survivors performed: yes. Additionally, immediately after death a complete necropsy was performed on all acute- and late mortalities. - Statistics:
- If possible, the calculation of the LD50 was done according to Finney D.Y.: Probit Analysis, 3. edition, Cambridge 1971.
Results and discussion
- Preliminary study:
- Four female rats were employed in a preliminary range finding study. The dosage of the single oral administration were 5000 and 2500 mg/kg of body weight.
At the dosage of 5000 mg/kg both treated animals died within 48 h p.a.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 647
- 95% CL:
- 3 114 - 4 567
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 317
- 95% CL:
- 2 596 - 3 853
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 478
- 95% CL:
- 3 108 - 3 878
- Mortality:
- 2500 mg/kg bw: 0/5 males and 0/5 females
3000 mg/kg bw: 1/5 males and 2/5 females
4000 mg/kg bw: 3/5 males and 4/5 females
5000 mg/kg bw: 5/5 males and 5/5 females - Clinical signs:
- other: The sample induced in the tested dosages in a high degree mainly obviously reduced activity partly with apathy, obvious disturbance of coordination, reduced reflex excitability, cyanosis/paleness of the mucous membrane, slight to obvious piloerection, mai
- Gross pathology:
- The mortalities showed at autopsy partly slight redness of the mucous membrane of the digestive system and solid residues of the sample.
Nothing abnormal was found in all animals necropsied at termination.
Any other information on results incl. tables
Number of animals dead and time range within which mortality occurred
Dose |
Mortality (# dead/total) |
Time range of deaths |
||
Male |
Female |
Combined |
||
2500 |
0/5 |
0/5 |
0/10- |
- |
3000 |
1/5 |
2/5 |
3/10 |
3 to 6/14 days |
4000 |
3/5 |
4/5 |
7/10 |
3 to 6/14 days |
5000 |
5/5 |
5/5 |
10/10 |
1 to 6/14 days |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- On the basis of the results obtained after a single oral administration, the oral LD50 after 14 d of the test article FETTSÄUREDIMETHYLAMINOPROPYLAMID (in arachis oil) was determined to be 3478 mg/kg bw . No significant effects on body weight were observed. The sample induced reduced activity (apathy), disturbance of coordination, reduced reflex excitability, cyanosis/paleness, piloerection, reduced body temperature and kachexia.
The mortalities showed residues of the sample in the digestive system and redness of the mucous membrane of the digestive system. Nothing abnormal was found in the animals necropsied on day 14.
Therefore the test substance FETTSÄUREDIMETHYLAMINOPROPYLAMID was judeged to be practically non- toxic based on the LD50 in males and females. - Executive summary:
In an acute oral toxicity study (standard acute method, according to OECD 401 (February, 1987) and the EEC directive 84/449 EEC), groups of 5 male and 5 female Wistar rats were given single oral doses of FETTSÄUREDIMETHYLAMINOPROPYLAMID in arachis oil and observed for 14 days.
Oral LD50 Males and Females combined after 14 days 3478 (3108 - 3878) mg/kg of body weight
Oral LD50 Males after 14 days: 3647 (3114 - 4567) mg/kg of body weight
Oral LD50 Females after 14 days: 3317 (2596 - 3853) mg/kg of body weight
The sample induced reduced activity (apathy), disturbance of coordination, reduced reflex excitability, cyanosis/paleness, piloerection, reduced body temperature and kachexia.
Post-dosing weight gains (2 week values) of the surviving animals did not show essential differences.
The mortalities showed residues of the sample in the digestive system and redness of the mucous membrane of the digestive system.
Nothing abnormal was found in the animals necropsied on day 14.
The test subance FETTSÄUREDIMETHYLAMINOPROPYLAMID IN ARACHIS OIL was judged to be practically non-toxic based on the oral LD50 in male and female rats.
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