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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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study conducted according to OECD TG 423, the LD50 cut-off in rats was determined to be 500 mg/kg bw. In addition, in an acute dermal toxicity study conducted according to OECD TG 402, the LD50 for acute dermal toxicity in rats was > 2000 mg/kg bw. Testing for acute inhalation toxicity was not performed because results from two routes of exposure are already provided and relevant exposure via the inhalation route is not very likely due to particle size and vapour pressure of the substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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
- 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 - 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.
- Preliminary study:
- n.a.
- 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".
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Study is a GLP-compliant Guideline study with Klimisch score 1.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- adopted 09th October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was used as delivered by the sponsor. In order to ensure good skin contact, it was moistened with 1 mL of aqua ad injectionem (Deltamedica, lot 910137, expiry date: September 2022). This vehicle was chosen due to its non-irritating characteristics. - 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: 9-12 weeks
- Weight at study initiation: 217-232 g
- Housing: The animals were kept in groups except during exposure and unless there were reasons to house individually (e.g. if there is concern that contact with other animals could increase stress due to the nature and severity of the signs of toxicity, or could result in exacerbation of local skin effects) 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: Adequate acclimatisation 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).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
- Type of wrap if used: The test item was held in contact with the skin by a dressing throughout a 24-hour period. This consisted of a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the residual test item was removed using aqua ad injectionem (sterile water).
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- For solids: The test item was used as delivered by the sponsor. In order to ensure good skin contact, it was moistened with 1 mL aqua ad injectionem. - Duration of exposure:
- 24 hours
- Doses:
- - 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404 (for details see Table 1 in box "Any other information on materials and methods incl. tables") at 24, 48 and 72 hours after patch removal.
- Frequency of weighing: The animals were weighed on day 1 (prior to the application), on days 8 and 15.
- Necropsy of survivors performed: At the end of the observation period the 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. In absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation
- Clinical signs: 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 6 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. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- n.a.
- Preliminary study:
- One animal was administered a dose of 2000 mg/kg bw. As the animal survived without showing any signs of systemic toxicity, this dose was used as a starting dose for the main study.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed after treatment with the test material.
- Clinical signs:
- other: No clinical signs were observed after treatment with the test material during the whole observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Other findings:
- No signs of acute dermal toxicity were observed after treatment with the test material during the whole observation period, but mild signs of irritation were observed in the main experiment which were fully reversible after Day 3 or Day 4 after patch removal (for details see Table 2 in section "Any other information on results incl. tables").
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study conducted according to OECD 402, N1,N3-diallylpropane-1,3-diamine dihydrochloride was dermally administered to rats for 24 hours. The application was associated with no mortality and neither signs of toxicity, except for mild signs of irritation which were reversible within 5 days. Based on the results, the dermal LD50 can be considered to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study conducted according to OECD 402, three female Wistar rats were dermally exposed to N1,N3-diallylpropane-1,3-diamine dihydrochloride (100% purity) under semi-occlusive conditions for 24 hours to approximately 10% of the total body surface at a dose of 2000 mg/kg bw. Animals were then observed for 14 days. There were no treatment related mortalities, no changes in body weight, no clinical signs or other signs of acute dermal toxicity, except mild signs of dermal irritation which were fully reversible within five days. Based on the results, the dermal LD50 can be considered to be greater than 2000 mg/kg bw and no classification according to CLP Regulation 1272/2008 is warranted.
Reference
Table 2: Skin Irritation at Application Site - Individual Data – DRF and Main Study
Time after Patch Removal |
Dose Range Finding Study |
Main Study |
||||
Animal No. 1* |
Animal No. 2** |
Animal No. 3** |
||||
E/O |
C |
E/O |
C |
E/O |
C |
|
Day 2 (0±2 h) |
0/0 |
nsf |
1°/0 |
nsf |
1°/0 |
nsf |
Day 3 (24±2 h) |
0/0 |
nsf |
1°/0 |
nsf |
1°/0 |
nsf |
Day 4 (48±2 h) |
0/0 |
nsf |
0/0 |
nsf |
1°/0 |
nsf |
Day 5 (72±2 h) |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Day 6 - 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Table 2: Absolute Body Weights [g] and Body Weight Change [%] - DRF and Main Study
Animal No. |
Absolute Body Weights [g] |
Body Weight Change [%] |
||
Day 1 |
Day 8 |
Day 15 |
Day 1-15 |
|
1* |
217 |
226 |
236 |
9 |
2** |
223 |
225 |
231 |
4 |
3** |
232 |
224 |
240 |
3 |
* = dose range finding study animal; ** = main study animal
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Suitable data is available for the substance N1,N3-diallylpropane-1,3-diamine dihydrochloride from Acute Oral and Dermal Toxicity studies conducted according to OECD TG 423 and 402.
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.
In an acute dermal toxicity study conducted according to OECD 402, three female Wistar rats were dermally exposed to N1,N3-diallylpropane-1,3-diamine dihydrochloride (100% purity) under semi-occlusive conditions for 24 hours to approximately 10% of the total body surface at a dose of 2000 mg/kg bw. Animals were then observed for 14 days. There were no treatment related mortalities, no changes in body weight, no clinical signs or other signs of acute dermal toxicity, except mild signs of dermal irritation which were fully reversible within five days. Based on the results, the dermal LD50 can be considered to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available study results, classification of N1,N3-diallylpropane-1,3-diamine dihydrochloride as Acute Tox 4, H302 is warranted in accordance with CLP Regulation 1272/2008.
No classification according to CLP criteria is warranted for the acute dermal toxicity endpoint since the LD50 value for the dermal route is above the limit value of the relevant OECD guideline.
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