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EC number: 812-745-6 | CAS number: 205041-15-2
- 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:
- 2020-04-16 to 2020-08-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- EC Number:
- 812-745-6
- Cas Number:
- 205041-15-2
- Molecular formula:
- C9 H20 Cl2 N2
- IUPAC Name:
- (prop-2-en-1-yl)({3-[(prop-2-en-1-yl)amino]propyl})amine dihydrochloride
- Test material form:
- solid
- Details on test material:
- - CAS: 205041-15-2
- Batch: LWDDP00072
- Colour: white
- Purity (GC): 100%
- Expiry date: 2020-08-11
- Storage conditions: room temperature
- Stability: stable under recommended storage conditions
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- In order to get the test item in a solution or suspension, which is applicable to the animals, aqua ad injectionem (Deltamedica, lot no. 901110, expiry date: December 2021) was evaluated as vehicle and was considered to be adequate. This vehicle was chosen due to its non-toxic characteristics.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : solution/suspension
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7-10 weeks
- Weight at study initiation: Step 1 (300 mg/kg bw): 164–168 g; Step 2 (2000 mg/kg bw): 177–191 g; Step 3 (300 mg/kg bw): 119–149 g
- Fasting period before study: Prior to the administration of the test material, food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water (sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least five days under laboratory conditions
- Microbiological status when known : The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare the animals were bred for experimental purposes.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: the vehicle was chosen due to its non-toxic characteristics
- Lot/batch no. (if required): Deltamedica, lot no. 901110, expiry date: December 2021
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: The surviving animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Frequency of observations: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Frequency of weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: The animal which had to be sacrificed for ethical reasons (animal no. 5, step 2) during the observation period was necropsied as soon as it was killed. At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. Macroscopic findings of the animal which had to be sacrificed for ethical reasons (animal no. 5, step 2) were red discoloured, fluid filled lungs. Due to these alterations lungs of animals no. 5 were preserved for a possible histopathological evaluation. - Statistics:
- n.a.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals treated with the test item at a dose of 300 mg/kg bw survived until the end of the study. Two animals treated with the test item at a dose of 2000 mg/kg bw died spontaneously on day 1 (animal no. 6) and on day 3 (animal no. 4) after treatment. One animal (no. 5) treated with the same dose level had to be sacrificed for ethical reasons on day 3 after treatment.
- Clinical signs:
- other: The six animals treated with the test item at a dose of 300 mg/kg bw showed no clinical findings of toxicological relevance. However, all animals of step 3 (animal no. 7, 8 and 9) showed a slight piloerection 1-2 hours after test item administration. All
- Gross pathology:
- At necropsy, no treatment-related macroscopic findings were observed in any surviving animals. Necropsy of the animal which had to be sacrificed for ethical reasons revealed diffuse red discoloured, fluid filled lungs (animal no. 5, step 2). Before the sacrifice the animal showed nasal discharge, which could be the initial reason for the reactions in the lungs by aspirating liquids into the respiratory tract. No other treated animal showed findings in the lungs. Due to these alterations lungs of animal no. 5 were preserved for a possible histopathological evaluation.
- Other findings:
- For details on results see Tables 1, 2 and 3 in box "Any other information on results incl. tables".
Any other information on results incl. tables
Table 1: Clinical signs
Step |
Animal No./Sex |
Starting dose (mg/kg bw) |
Time of observation |
Observations |
1 |
1 / female |
300 |
d 1 – d 15 |
nsf |
|
2 / female |
|
d 1 – d 15 |
nsf |
|
3 / female |
|
d 1 – d15 |
nsf |
2 |
4 / female |
2000 |
0 min – 30 min |
nsf |
|
|
|
60 min |
hunched posture, half eyelid closure, slightly reduced spontaneous activity |
|
|
|
120 min – 240 min |
apathy, hunched posture, piloerection, half eyelid closure, slightly reduced spontaneous activity |
|
|
|
d 2 |
piloerection, half eyelid closure, slightly reduced spontaneous activity |
|
|
|
d 3 |
found dead |
|
5 / female |
|
0 min – 30 min |
nsf |
|
|
|
60 min – 180 min |
apathy, hunched posture, slightly piloerection, half eyelid closure, slightly reduced spontaneous activity
|
|
|
|
240 min |
apathy, hunched posture, slightly piloerection, slightly reduced spontaneous activity |
|
|
|
d 2 |
slightly piloerection, half eyelid closure, slightly reduced spontaneous activity |
|
|
|
d 3 |
apathy, hunched posture, slightly piloerection, half eyelid closure, slightly reduced spontaneous activity, hyperesthesia, nasal discharge, euthanised for animal welfare reasons |
|
6 / female |
|
0 min |
nsf |
|
|
|
30 min |
apathy, slightly reduced spontaneous activity, |
|
|
|
60 – 240 min |
apathy, hunched posture, slightly piloerection, half eyelid closure, slightly reduced spontaneous activity |
|
|
|
360 min |
found dead |
3 |
7, 8, 9 / female |
300 |
0 – 30 min |
nsf |
|
|
|
60 – 120 min |
slightly piloerection |
|
|
|
180 min – d 15 |
nsf |
d = study day (study day 1 = day of administration); min = minute(s) post-application; nsf = no specific findings
Table 2: Individual data on necropsy findings
Step |
Animal No. / Sex |
Starting Dose (mg/kg bw) |
Organ |
Macroscopic Findings |
1 |
1 / Female |
300 |
- |
nsf |
2 / Female |
- |
nsf |
||
3 / Female |
- |
nsf |
||
2 |
4 / Female |
2000 |
all examined organs |
autolytic |
5 / Female |
lung |
diffuse red discoloured, fluid filled |
||
6 / Female |
gastrointestinal tract |
autolytic (fluid filled) |
||
3 |
7 / Female |
300 |
- |
nsf |
8 / Female |
- |
nsf |
||
9 / Female |
- |
nsf |
nsf = no specific findings
Table 3: Absolute Body Weights in g and Body Weight Change in %
|
Step |
Animal No. / Sex |
Starting Dose |
BW (g) |
Body Weight Change in Comparison to Day 1 (%) |
|||||
|
Day 1 |
Day 8 |
Day 15 |
Day 15 |
||||||
|
1 |
1 / Female |
300 |
168 |
194 |
206 |
23 |
|||
|
2 / Female |
167 |
188 |
200 |
17 |
|||||
|
3 / Female |
164 |
189 |
199 |
21 |
|||||
|
2 |
4 / Female |
2000 |
191 |
n.a.* |
n.a.* |
n.a.* |
|||
|
5 / Female |
186 |
n.a.** |
n.a.** |
n.a.** |
|||||
|
6 / Female |
177 |
n.a.*** |
n.a.*** |
n.a.*** |
|||||
|
3 |
7 / Female |
300 |
119 |
148 |
163 |
37 |
|||
|
8 / Female |
145 |
178 |
193 |
33 |
|||||
|
9 / Female |
149 |
174 |
197 |
32 |
* found dead on day 3
** euthanised for animal welfare reasons on day 3
*** found dead on day 1
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute oral toxicity study in rats conducted according to OECD 423, the test material N1,N3-diallylpropane-1,3-diamine dihydrochloride did not show mortality or any signs of toxicity when administered at doses of 300 mg/kg bw. After treatment with 2000 mg/kg bw, two animals died spontaneously on day 1 and day 3 after treatment and one animal had to be sacrificed for ethical reasons. Based on the results, the LD50 cut-off value is therefore considered to be 500 mg/kg bw.
- Executive summary:
In an acute oral toxicity study conducted according to OECD 423 (acute toxic class method), groups of female Wistar rats (3/step) were given a single oral dose of N1,N3-diallylpropane-1,3-diamine dihydrochloride (100% purity) in water at levels of 300 and 2000 mg/kg bw. Animals were then observed for 14 days.
At a dose level of 300 mg/kg bw, there were neither mortalities nor clinical findings of toxicological relevance. However, 3 out of 6 treated animals at this dose level showed a slight piloerection 1-2 hours after test item administration. All animals completely recovered within 3 hours and therefore these findings are assumed to be a sign of discomfort to the test item administration rather than a toxicological effect. No specific gross pathological changes were recorded for surviving animals.
After oral administration of 2000 mg/kg bw, two animals died spontaneously on day 1 and day 3 after treatment. One animal had to be sacrificed for ethical reasons on day 3 after treatment. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and apathy. The clinical signs persisted until the premature end of the observation period in all animals. Necropsy of the animals, which were found dead showed the beginning of autolysis, necropsy of the animal which had to be sacrificed for ethical reasons revealed diffuse red discoloured, fluid filled lungs. There were no treatment related changes in body weight at either dose level.
In accordance with OECD TG 423, the LD50 cut-off value for N1,N3-diallylpropane-1,3-diamine dihydrochloride after a single oral administration is considered to be 500 mg/kg bw.
This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (OECD 423) in the rat.
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