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EC number: 276-432-0 | CAS number: 72162-46-0
- 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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(isodecyloxy)propyl]propane-1,3-diamine
- EC Number:
- 276-432-0
- EC Name:
- N-[3-(isodecyloxy)propyl]propane-1,3-diamine
- Cas Number:
- 72162-46-0
- Molecular formula:
- C16H36N2O
- IUPAC Name:
- (3-aminopropyl)({3-[(2-methylnonyl)oxy]propyl})amine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Italy
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 150 - 174 g
- Fasting period before study: overnight
- Housing: solid bottomed cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous solution of carboxymethylcellulose
- Doses:
- 300 mg/kg body weight, 50 mg/kg body weight
- No. of animals per sex per dose:
- 6 female animals (300 mg/kg group)
6 female animals (50 mg/kg group) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality / morbidity twice daily, clinical signs daily, body weights on day 1, 2, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- mortality rate at 300 mg/kg body weight: 4 out of 6 females [1 of 3 female animal from subgoup 1 (300 mg/kg body weight) plus 3 of 3 female animals from subgroup 2 (300 mg/kg body weight)];
mortality rate at 50 mg/kg body weight: 0 out of 6 females - Clinical signs:
- other: 300 mg/kg body weight: hunched posture, piloerection, reduced activity 50 mg/kg body weight: salivation, rales, reduced activity, piloerection
- Gross pathology:
- No abnormalities at necropsy (neither at 300 mg/kg body weight nor at 50 mg/kg body weight)
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median letal dose (LD50) after oral administration of the registration substance to rats is between 50 mg/kg body weight (0% mortality) and 300 mg/kg body weight (67% mortality). Based hereupon the registration substance is considered to be toxic if swallowed (category 3 according to GHS-CLP).
- Executive summary:
The acute toxicity of the registration substance was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. The study was performed according to OECD TG 423 (acute toxic class method) and followed the principles of GLP. Two doses in 4 different testong steps (subgroups) had been investigated.
300 mg/kg (Steps 1 and 2)
A sub-group of 3 female animals was initially dosed at 300 mg/kg (Step 1). One animal was found dead on Day 8 of the study. Hunched posture, piloerection, thin appearance, reduced activity, brown staining on the muzzle and semi-closed eyes were observed before death. No mortality nor significant clinical signs were observed in the remaining two animals. A second sub-group of 3 female animals was then dosed at the same dose level (Step 2). All animals were found dead between Day 2 and 3 of the study. The following signs were noted before death: salivation, piloerection, hunched posture, soft faeces, reduced activity and semi-closed eyes. No abnormalities were observed at necropsy examination performed on all animals at the end of the observation period, including the early decedent animals.
50 mg/kg (Steps 3 and 4)
A third sub-group of 3 females was dosed at 50 mg/kg (Step 3). No deaths occurred and clinical signs observed on the day of dosing were limited to salivation and rales. Two out of three animals recovered by 2 hours after dosing. A single animal generally showed clinical signs like salivation, rales, reduced activity, piloerection, brown staining on the muzzle, swollen abdomen, difficulty in respiration and pallor until the last day of the observation period. Body weight losses or reduced body weight gain were noted in these animals during the observation period. No mortality occurred in the 3 females subsequently dosed at 50 mg/kg (Step 4). Piloerection, hunched posture and reduced activity were observed up to Day 3. Recovery occurred by Day 4. Body weight and body weight changes observed in these animals were within the expected range for this strain and age of animals at the end of the study. No abnormalities were observed at necropsy examination performed in animals treated at 50 mg/kg (Steps 3 and 4) at the end of the observation period. Abnormal shape (swelling and/or distention) and/or abnormal content (gas) of stomach, duodenum, jejunum, ileum, caecum and colon, as well as small spleen, were observed only in a single animal.
These results indicate that the test item has some toxic effects (including mortality) in the rat following oral administration of a single dose at 300 mg/kg. No mortality nor severe signs of toxicity were observed following dosing at 50 mg/kg. These results indicate the LD50 to be greater than 50 but lower than 300 mg/kg body weight.
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