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Diss Factsheets
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EC number: 417-040-3 | CAS number: -
- 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
No toxicokinetic data (animal or human studies) are available on Coag 122 (solid). The data present in this dossier are based on physico-chemical parameters and will allow a qualitative assessment of the toxicokinetic behaviour of this substance.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
Additional information
Coagulant 122 (solid), N,N-bis(2-hydroxypropyl)-hydroxylamine (HPHA) is typically 88% pure and contains the
major impurities 1-(N-(2-hydroxypropoxy-2-methyl-ethyl)-hydroxylamino)propane-2-ol and 2-(N-2-hydroxypropyl-hydroxylamino)propane-1-ol.
It is a stabiliser used as an oxygen scavenger in boiler feed water and as a polymerisation inhibitor in the petrochemical and refining industries. It is an off white waxy solid, with a melting point of 13 - 38 °C and a molecular weight of 149.21 Coagulant 122 (solid) has a vapour pressure of 0.0135 Pa, a partition coeficient (log Pow) of -0.53 and is miscible with water (>92.6% w/w at 20°C).
Toxicity
Acute oral toxicity. At a limit dose of 2500 mg/kg, there were no mortalities. All animals of both sexes appeared normal through out the 14 day observation period.
Acute dermal toxicity. At a limit dose of 2000 mg/kg there were no mortalities, systemic reactions or local reactions to treatment. There were slightly low body weight gains in three male and three female animals on Day 8, with a similar trend noted for three males and one female on Day 15. All other rats achieved a satisfactory body weight gain throughout the study.
Skin írritation. A single semi-occlusive application of Coagulant 122 (solid) produced no irritation. There were no signs of toxicity or ill health in any rabbit.
Eye initaion. A single instillation of Coagulant 122 (solid) elicited very slight transient conjunctival irritation. All reactions were resolved one or two days after instillation.
28 day sub-acute toxicity study. Groups of five male and five female rats received 15 or 150 or 1000 mg/kg/day via oral gavage. No animals died during the study and there were no clinical signs of toxicological importance. Body weight and food consumption were not affected. There were no changes in macro- or microscopic pathology, haematology, biochemistry or urinalysis, that were considered to be treatment related or of toxicological importance.
1000 mg/kg/day was considered to represent a no-observed-effect level for Coagulant 122 (solid) in rats.
Mutagenicity : Metabolism.
No toxicity or mutagenic activity were seen in the Ames test either in the absence or presence of S-9 mix. In the in vitro cytogenetics assay Coagulant 122 (solid) was clastogenic in the absence of S-9 mix but not in its presence. In addition, Coagulant 122 (solid) was slightly less toxic in the presence of S-9 mix. These findings might indicate Cytochrome P450 detoxification, but might also be a consequence of the reduced exposure time in the presence of S-9 mix due to its inherent toxicity.
Assessment
Coagulant 122 (solid) is miscible with water and has a low molecular weight indicating that the chemical has potential for bioavailability although the low partition coefficient indicates that it is unlikely to accumulate.
The solid is waxy and thus it is unlikely to be an inhalation hazard in terms of dust but the vapour pressure does suggest that exposure to vapour is a possibility, especially on heating. The results of the acute oral toxicity study indicate that the substance was systemically nontoxic, in the repeat dose study there was no evidence of toxict or accumulation. The results of the acute dermal toxicity test indicate that when applied dermally, Coagulant 122 (solid) is neither systemically nor topically toxic. In the in vitro cytogenetics assay the fact that the test substance was clastogenic without S-9 mix but not with S-9 mix may indicate that Coagulant 122 (solid) is metabolised by Cytochrome P450, but alternatively might also be a reflection of the longer exposure time used in the absence of S-9 mix.
Based on molecular weight and log P between -1 and 4, the dermal absorption factor might therefore be set to 100% ( ECHA guidance on IR&CSA, R.7c).
Based on high water solubility and high hydrophilicity of the substance, the oral absorption factor might therefore be set to 100% ( ECHA guidance on IR&CSA, R.7c).
Conclusion
The results of the toxicity studies conducted on Coagulant 122 (solid) show no evidence of systemic toxict. Consequently, little can be inferred about the systemic absorbtion of the material, other than to speculate, on the basis of the complete lack of toxicologically significant effects in any of the pararmeters investigated in the 28 day study, that the material is indeed poorly absorbed.
The in vitro cytogenetics study provides circumstantial, but not conclusive evidence of metabolism and due to the lack of clinical, biochemical or pathological findings (in turn quite possibly due to lack of absortition) no comment can be made about distribution or excretion.
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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