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Diss Factsheets
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EC number: 205-593-1 | CAS number: 143-23-7
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data are available for the registration substance. However adequate and reliable repeated dose toxicity studies performed with a surrogate substance (multi-constituent substance containing high levels of this registration substance) are at hand.
In these subchronic toxicity studies rats were exposed either to aerosol (inhalation exposure) or via oral gavage. In these studies no effects on the macroscopically and microscopically investigated glands and organs related to reproduction were observed. No further studies are available.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
No data are available for the registration substance. However an adequate and reliable teratogenicity study performed with a surrogate substance (multi-constituent substance containing high levels of this registration substance) is at hand. In this study the test item was administered to pregnant rats from gestation day 6 - 15. Maternal effects were early deaths as well respiratory rales in all treated groups. In the foetuses no treatment related effects on foetal ossification variations, external, soft tissue or skeletal malformations could be found. With regard to the present study a No Observed Adverse Effect Level (NOAEL) for maternal toxicity could not be established. The respective maternal LOAEL (including effects on reproduction and fertility) in this study is 50 mg test material/kg/day (recalculated to LOAEL = 20 mg/kg/day based on the submission susbtance content in the test material). Based on the lack of any effects concerning the foetal development the developmental NOAEL of this study is 250 mg test material/kg/day (corresponding to 100 mg submission substance/kg/day).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Dose descriptor:
- LOAEL
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- recalculated to the content of the submission subtance in the test material
- Basis for effect level:
- clinical signs
- mortality
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- recalculated to the content of the submission subtance in the test material
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity - no treatment -related, biological meaningful effects were observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Oral administration of the test item to the rat at doses of 0, 50, 100 or 250 mg/kg body weight from gestation day 6 - 15 caused early deaths as well respiratory rales in the maternal animals. In the foetuses no treatment related effects on foetal ossification variations, external, soft tissue or skeletal malformations could be found. With regard to the present study a No Observed Adverse Effect Level (NOAEL) for maternal toxicity could not be established. The respective maternal LOAEL (including effects on reproduction and fertility) in this study is 50 mg/kg/day (recalculated to LOAEL = 20 mg/kg/day based on the submission susbtance content in the test material). Based on the lack of any effects concerning the foetal development the developmental NOAEL of this study is 250 mg test material/kg/day (corresponding to 100 mg submission substance/kg/day).
- Executive summary:
The study used as source investigated Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine (EC 907 -605 -7, which contains relevant amounts of the submission substance,
7-azatridecane-1,13-diamine).
The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Reliable and adequate study with a surrogate substance of the submission study available (Klimisch 2).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the absence of effects on reproductive organs as well as no developmental toxic effects were noted in the above presented studies and based on the criteria in Regulation (EC) No 1272/2008 no classification for reproductive toxicity is proposed.
Additional information
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.