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EC number: 266-235-8 | CAS number: 66204-44-2
- 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 data are available on effects of the substance after repeated dermal and inhalation exposure.
In a 90-Day subchronic gavage study in rats according to OECD guideline 408 (Rajesh 2001) slight effects on body weight gain and alterations in clinical chemistry in males of the high dose group have been detected. These data suggested a LOAEL of 180 mg/kg bw/day. However, concerning clinical chemistry parameters no historical control data of this laboratory were given. The toxicological relevance of other effects was questionable. No local effects in the stomach were found although such effects are expected. These data suggest that the MTD was not reached in this study. Furthermore, pulmonary infection due to Mycoplasma spec. has been detected in all groups including controls. Altogether, this study has limitations.
In a 2nd 90-Day subchronic gavage study in rats (OECD guideline 408; Leuschner 2002) the test substance induced local effects in the stomach at a dose level of ≥ 60 mg/kg bw. Other effects at the mid and high dose level (% of granulocyes increased, % of lymphocytes decreased), are considered to be a consequence of this chronic ulcerative gastritis & peritonitis. The toxicological relevance of the reduced pupil size detected in males and females of the high dose group is not clear. The dose levels of 0, 20, 60, 180/120 mg/kg bw/day correspond to a concentration of 0, 0.4, 1.2, 3.6/2.4% in corn oil. Effects in the stomach were detected at a concentration of 1.2%.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The substance induced local effects in the stomach of rats after repeated administration via gavage at ≥ 60 mg/kg bw (LOAEC 1.2%). The NOAEL is 20 mg/kg bw/day (NOAEC 0.4%).
The implementation of a subchronic oral study in a 2nd species is scientifically unjustified because mainly local concentration- dependent effects are expected with the substance which have been sufficiently demonstrated. Furthermore, the implementation of a subacute or subchronic dermal toxicity study in rats is scientifically unjustified because of the corrosive properties of the substance.
Inhalative exposure to the substance is not probable, but rather to the hydrolysis product formaldehyde, which is sufficiently investigated. Therefore the NOAEL of 1.2 mg/m³ for formaldehyde will be applied for assessing the risk from inhalation exposure to the constituents of the reaction product.
The NOAELs for formaldehyde reported in oral subchronic or chronic studies are in the same dose range. For all compounds irritation at the site of contact is the main effect. The LOAECs/NOAECs are lower (formaldehyde) than the concentrations of the substance.
Although the data on 2-hydroxypropylamine are of limited validity, there is some indication that the toxic effects of 2-hydroxypropylamine after repeated oral or inhalation exposure occurred at much higher dose levels. They are therefore not relevant for the overall NOAEL. The NOAEL from the 90 day study of 20 mg/kg bw (concentration: 0.4%) may be used for the risk assessment. This NOAEL refers to local effects in the stomach. The NOAEL for systemic effects is 60 mg/kg bw, based on the reduced pupil size at the high dose level.
Chronic studies are available for formaldehyde and these studies indicated local effects at the site of contact.
Repeated dose toxicity: via oral route - systemic effects
(target organ) digestive: stomach
Justification for classification or non-classification
The effects observed in the valid 90-Day oral toxicity study in rats were limited to the stomach due to the irritating potential of the test substance. This finding is not relevant for the human. Therefore no classification is required.
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