Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-882-0 | CAS number: 13531-52-7
- 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
Link to relevant study record(s)
Description of key information
For N3-amine, no toxicokinetic studies are on-hand. However, based on the available data of the source substance N4-amine following conclusions are made to characterize also the target substance N3-amine (for read-across justification please refer to IUCLID chapter 13).
N4-amine is a liquid, viscous, organic, colourless substance with a small molecular weight of 174.2871 g/mol, indicative for a favorable absorbance. The source substance is miscible with water at 20.0°C in any ratio. Due to this high water solubility, it is predicted that N4-amine is readily dissolved into the gastrointestinal fluids. An oral and dermal absorption is assumed. A distribution to several organs after repeated oral administration is indicated since damages in these organs were found (study acc. to OECD 422). Due to the relatively low vapor pressure of the source substance (2.2 hPa at 20°C), the volatility of the substance is rather low and inhalation exposure to vapors is hence considered to be low. Furthermore, some data on N3/N4-amine as second source substance are available. N3/N4-amine is a clear yellowish liquid with a small molecular weight of 113.162 g/mol, indicative for a favorable absorbance. This source substance is miscible with water at 20.0°C in any ratio. Due to this high water solubility, it is predicted that N3/N4-amine is readily dissolved into the gastrointestinal fluids. An oral and dermal absorption is assumed. Although the vapor pressure of N3/N4-amine (26.4 hPa at 20°C) is moderate, an inhalation risk test showed no mortality, when 12 rats were exposed for 8 hours to an atmosphere that has been saturated at 20 degrees. Therefore, the exposure to vapors is considered to be of low risk. Furthermore, 8 hours exposure to the target substance N3-amine to an atmosphere that has been saturated at 20 degrees centigrade did not result in mortality in rats.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Assessment of the Toxicokinetic Behaviour (source substance N4-amine / target substance N3-amine)
Since no toxicokinetic studies are available for N4-amine, the following assessment is based on the available physicochemical properties and results from other toxicological studies:
N4-amine is a liquid, viscous, organic, colourless substance with a small molecular weight of 174.2871 g/mol, indicative for a favourable absorbance of the test item.
The source substance is miscible with water at 20.0°C in any ratio. Due to this high water solubility, it is predicted that the source substance is readily dissolved into the gastrointestinal fluids.
Due to the relatively low vapour pressure of the test substance (2.2 hPa at 20°C), the volatility of the substance is rather low and inhalation exposure to vapors is hence considered to be low.
Adsorption
The partition coefficient of the source substance (Log Pow) is -1.55 at 23°C at pH 11.3. For the target substance N3-amine, a Log Pow of -1.67 at 23°C at pH 10.9 was identified (BASF AG, 2014). Furthermore, the target substance was shown to be miscible in water in any ratio at 20 °C (BASF AG, 2014). Based on the rather low partition coefficients source substance and target substance are unlikely to bioaccumulate with the repeated intermittent exposure patterns normally encountered. However, this low log Pow value and the high water solubility and the small molecular weight indicates that the source substance might be favorable for passive diffusion. In line with this, in an acute oral toxicity study, 5/5 males and females and 4/5 females died after administration of 1397 mg/kg bw and 1/5 males died after administration of 950 mg/kg bw, respectively, whereas animals receiving 647 mg/kg did not show any signs of mortality (-> LD50 = 1140 mg/kg). Furthermore, animals receiving high and intermediate doses showed clinical signs and symptoms, including poor general state, apathy, abdominal or lateral position, spastic gait, atonia, and diarrhea. These observations are in line with the low log Pow value, showing that the substance is systemically bioavailable when administered orally. It is therefore assumed that the source substance or its possible metabolites become systemically available after absorption along the gastrointestinal tract.
Furthermore, bioavailability via the dermal route is also assumed since the LD50 was estimated to be 190 mg/kg bw in an acute dermal toxicity study with rabbits (BASF AG, 1977). The animals showed clinical signs such as apathy, dyspnea, cyanosis, tremor, piloerection, blood-coloured urine with hematoma and poor general state. Furthermore, the substance is corrosive (BASF AG, 1977) and sensitizing after skin contact (BASF SE, 2008), further supporting the notion that there is a high bioavailability of the source substance via the dermal route.
For the target substance a similar acute oral toxicity (LD50-rat: 654 mg/kg bw) and a comparable acute dermal toxicity (LD50-rabbit: 184 mg/kg bw) were observed (BASF AG, 1977). Due to this, it is assumed that there is also high bioavailability of the target substance via the oral and the dermal route of ingestion. N3-amine is also corrosive after skin contact (BASF AG, 1977).
Distribution
Damages of spleen, adrenal gland, kidneys, stomach, eyes and lungappeared to be possible target organs in the combined repeated dose toxicity study with the reproduction / developmental toxicity screening test of the source substance (BASF SE, 2013). Therefore, a distribution into these organs is assumed at toxic doses. Since N4-amine is a small water-soluble molecule it probably diffuses through aqueous channels and pores.
Metabolism
Using the OECD toolbox vs.3.0, the liver metabolism simulator provided 21 potential simulated metabolites were found for the source substance, as well as 22 simulated skin metabolites. Studies assessing genotoxicity (Ames-Test; BASF 2012, HPRT test in vitro; BASF 1997, Chromosome aberration in vitro; BASF 1997) were negative, i.e. there is no indication of a reactivity of N4-amine or its metabolites with macromolecules under the chosen test conditions. With reference to the target substance, no genotoxic potential was identified in the AMES-Test (BASF AG, 1990), too. No further data available.
Excretion
No data available.
Based on the molecular weights of its main constituents and its water solubility, it is conjectured that the source substance and test substance would probably primarily undergo a renal elimination.
Conclusive remark on ADME of the target substance based on available data
Based on the similarity of the source substance (N4 -amine) and the target substance (N3 -amine) given information are satisfactory to evaluate this issue in an adequate manner.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.