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EC number: 254-754-2 | CAS number: 40027-38-1
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral LD50 between 300 and 2000 mg/kg bw, with a cut-off of 500 mg/kg bw. Acute dermal and inhalation toxicity have not been evaluated following the corrosive properties and the very low vp of the pasty 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:
- 04 June 2018 - 05 July 2018
- 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:
- December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
- Version / remarks:
- November 2000, including the most recent revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adult animals of approx. 9-10 weeks old
- Weight at study initiation: 155 to 185 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
- Housing: Group housing of 3 animals per cage in polycarbonate cages (MIV type; height 18 cm.), containing sterilized sawdust as bedding material and paper as cage-enrichtment.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18-24 (actual: 21-22)
- Humidity (%): 40-70 (actual: 32-72) - this deviation is considered not to have affected the integrity of the study because it did not noticeably affect the clinical condition of the animals or the outcome of the study.
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 June 2018 - 05 July 2018 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- Specific gravity: 1.036
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION:
- The dosing formulations were stirred continuously during administration.
CLASS METHOD:
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item. - Doses:
- The study was conducted in a stepwise manner with four groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. Based on the results, the second group was dosed at 2000 mg/kg two days after the first group based on the absence of severe tox signs. Based on results, two additional groups were dosed at 300 mg/kg.
- No. of animals per sex per dose:
- 12 females (3 animals/dose group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
*Mortality/Viability: twice daily;
*Body weights: on the day of dosing (fasted weight) and on days 1 (pre-administration), 8 and 15;
*Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - At 2000 mg/kg, four animals were killed in extremis on Day 6 and one animal was found dead on day 7.
- At 300 mg/kg, no mortality occurred. - Clinical signs:
- other: - At 2000 mg/kg, for the first dose group, hunched posture and piloerection were noted between days 1 and 3. In addition, lethargy, hunched posture, piloerection, chromodacryorrhoea, lean appearance and/or ptosis were noted prior to sacrifice on day 6. At
- Gross pathology:
- General emaciation, abnormalities of the stomach (irregular surface of the forestomach) and adrenal glands (both sides enlarged) and yellowish watery-cloudy contents of the jejunum,
ileum and caecum were found in three out of five animals that died or were sacrificed for humane reasons during the study, at macroscopic post mortem examination. Macroscopic
post mortem examination of the other animal that was sacrificed during the study and of the surviving animals at termination did not reveal any abnormalities. - Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Classified Category 4 according to Regulation (EC) No. 1272/2008
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD/EC test guidelines, the LD50 of N-(Oleyl alkyl)-1,3-propanediamine mono oleate was established to be within the range of 300-2000 mg/kg body weight, with a cut-off of 500 mg/kg bw.
- Executive summary:
Acute oral toxicity of N-(Oleyl alkyl)-1,3-propanediamine mono oleate was evaluated in an OECD 423 (Acute Toxic Class Method)study, performed under GLP.
Dosing was done by oral gavage to groups of three female Wistar rats in a volume of 10 mL/kg bw propylene glycol. The first group was dose at 2000 mg/kg body weight. In a stepwise procedure three additional groups of three females were dosed at 2000, 300 and 300 mg/kg body weight.
Mortality: At 2000 mg/kg, four animals were killed in extremis on day 6 and one animal was found dead on day 7. in the first three animals, 2 were sacrificed on day 6, and one was found 1 dead day 7. From the second three animals that were already dosed in the mean-time, 2 were sacrificed day 6 and one survived until end of observation period. At 300 mg/kg, no mortality occurred. Severe effects were observed at clinical observations 2000 mg/kg bw, especially prior to sacrifice. At 300 mg/kg, hunched posture, uncoordinated movements and/or piloerection were noted for the animals between Days 1 and 6.
Macroscopic Findings involved general emaciation, abnormalities of the stomach, enlarged adrenal glands and yellowish watery-cloudy contents of the intestines were found in four out of five animals that died or were sacrificed. Macroscopic post mortem examination of the other animal that was sacrificed during the study and of the surviving animals at termination did not reveal any abnormalities.
Regarding dosing a second group at 2000 mg/kg: the second group was dosed two days after the first group based on the absence of severe tox signs. Unfortunately delayed toxicity resulting in death was noted for the animals after dosing the second group.
The LD50 is concluded to be between 300 and 2000 mg/kg bw, with a cut-off of 500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- According to GLP and recent guidelines.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
The acute oral toxicity was evaluated by Acute Toxic Class method (OECD 423).Groups of three female Wistar rats were dosedOleyl-diamine mono-oleateby oral gavage in a volume of 10 mL/kg bw propylene glycolThe first group was dose at 2000 mg/kg body weight. In a stepwise procedure three additional groups of three females were dosed at 2000, 300 and 300 mg/kg body weight.
Mortality: At 2000 mg/kg, four animals
were killed in extremis on day 6 and one animal was found dead on day 7.
in the first three animals, 2 were sacrificed on day 6, and one was
found 1 dead day 7. From the second three animals that were already
dosed in the mean-time, 2 were sacrificed day 6 and one survived until
end of observation period. At 300 mg/kg, no mortality occurred. Severe
effects were observed at clinical observations 2000 mg/kg bw, especially
prior to sacrifice. At 300 mg/kg, hunched posture, uncoordinated
movements and/or piloerection were noted for the animals between Days 1
and 6.
Macroscopic Findings involved general emaciation, abnormalities of the stomach, enlarged adrenal glands and yellowish watery-cloudy contents of the intestines were found in four out of five animals that died or were sacrificed. Macroscopic post mortem examination of the other animal that was sacrificed during the study and of the surviving animals at termination did not reveal any abnormalities.
The LD50 was determined to be between 300 and 2000 mg/kg bw, with a cut-off of 500 mg/kg bw.
Acute dermal toxicity:
There is no dermal LD 50 value for acute skin toxicity of Oleyl-diamine mono-oleate, and due to the corrosive properties combined with relative low oral toxicity of the substance, it is not ethical to carry out this animal study.
Acute inhalation toxicity:
There is no study on inhalation toxicity available for Oleyl-diamine mono-oleate.
REACH stipulates that testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. REACH guidance R.7.a, chapter. 7.4 Acute toxicity indicates that in principle no inhalation studies are needed when vp < 0.1 Pa at 20°C or particle size > 100 µm. Oleyl-diamine mono-oleate a paste with a vapour pressure of ≤ 0.00087 Pa at 25 °C. Its use is limited to industrial and professional users and does not involve the forming of aerosols, particles or droplets of an inhalable size. So exposure to humans via the inhalation route will be unlikely to occur.
No information on viscosity is available at 40°C, and hence the hazard for aspiration cannot be adequately assessed.
Justification for classification or non-classification
The LD50 was determined to be between 300 and 2000 mg/kg bw, with a cut-off of 500 mg/kg bw.
The substance therefore need to be classified under CLP for acute oral toxicity asCategory 4, with H302: Harmful if swallowed.
Dermal systemic toxicity is expected to be low, while corrosive properties will limit likelihood of exposures.
Related to low vp and no inhalable particles, there will be low likelihood of exposures via inhalation.
No classification STOT-SE Cat.3 needed:
The active substance is not structurally related to any known class of neurotoxic chemicals.
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