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Diss Factsheets
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EC number: 205-596-8 | CAS number: 143-27-1
- 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
No test with the target substance is available. The three source substances are classified as STOT RE 2, H373 (may cause damage to organs through prolonged or repeated exposure; target organs: gastro-intestinal tract, liver, immune system). The target substance is classified as STOT RE 2, H373 (gastro-intestinal tract, liver, immune system) according to the precautionary principle.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
Details on repeated dose studies for source substances (according to ECHA 2008, EU RISK ASSESSMENT - PRIMARY ALKYL AMINES):
Source substance 1
In a 28-day study on tallow alkylamines, which was compliant to the OECD 407 test guideline for the general toxicity, the predominant toxic effects were dilation and mucosal erosion of the gastrointestinal tract associated with emaciation, general poor health status and unscheduled deaths at 150 mg/kg bw/d. Besides, a dose-dependent slight to marked accumulation enteropathy was predominant in the distal parts of the small intestine of rats at all test doses. The accumulation of the test substance in histiocytes was obvious in the draining (mesenteric) lymph nodes, but also in the intestinal submucosa. Other treatment- elated adverse effects were liver toxicity, immunosuppression of lymphoid tissues, adrenal hyperplasia. Additional effects (mucosal hyperplasia in the intestine, leukocytosis) were associated with the primary damage of the gastrointestine. The LOAEL was 12.5 mg/kg bw/d.
Source substance 2
No repeated-dose toxicity study on animals that fully meets the testing standards is available.
Source substance 3
Repeated dermal application of the test item caused concentration-dependent mild to severe irritative to corrosive skin effects in rats. The lowest concentration tested (0.3%,≈12.5 mg/kg bw/d) in the dermal studies was the LOAELlocal for this route. Systemic toxicity was not adequately addressed in these studies. A guideline-compliant oral 28-day study in rats did not induce adverse effects at 3.25 mg/kg bw/d (NOAEL). Indications of toxicity at 50 mg/kg bw/d were growth depression at normal food consumption and increased enzyme activities indicative for minor liver or/and kidney dysfunctions. Motoric abnormalities (stilted gait), hemoconcentration and leucocytosis/ neutrophilemia observed at 50 mg/kg bw/d could not be related to other primary organ damage. Doses up to 50 mg/kg bw/d had no irritative properties on the mucosa of the gastrointestinal tract, while such effects associated with mortalities were seen at 400 mg/kg bw/d during week one of a preliminary study.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on repeated dose toxicity, the test item is classified and labelled as may cause damage to organs through prolonged or repeated exposure (STOT RE2, H373) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.
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.
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