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EC number: 266-357-1 | CAS number: 66422-95-5
- 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
The test substance 2,4-diaminophenoxyethanol dihydrochloride was administered daily by gavage to Sprague-Dawley rats at the dose level of 4, 20 or 100 mg/kg bw/day for 13 weeks. At 4 and 20 mg/kg bw/day the test item was well tolerated. A 100 mg/kg bw/day, ptyalism was observed in both males and females and lower body weight gains were noted for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4 week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg bw/day on completion of treatment and treatment-free periods. Under the experimental conditions of the study, the NOEL is established to be 20 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The objective of this study was to evaluate the potential toxicity of the test item 2,4 -diaminophenoxyethanol dihydrochloride following daily oral administration (gavage) to rats for 13 weeks. On completion of the treatment period, designated animals were held for a 4 -week treatment free period in order to evaluate the reversibility of any findings.
A total of 140 Sprague-Dawley rats (70 males/70 females) were allocated to three treatment groups and one control group. Each group was composed of 10 males and 10 females. Recover animals (6 males and six females) were added to the control and high dose groups for a 4 -week treatment free period. The test item was administered daily by gavage as a solution in the vehicle (purified water) at the dose level of 4, 20 or 100 mg/kg bw/day for 13 weeks. Control animals received the vehicle alone under the same experimental conditions. The animals were checked daily for mortality and clinical signs. detailed clinical observations were carried out weekly and a functional observation battery was conducted at the end of the treatment period. Body weight and food consumption were recorded once a week throughout the study. Ophthalmological examinations were performed before and at the end of the treatment period. Haematological and blood biochemical investigations and urinalysis were performed at the end of the treatment period. On completion of the treatment or treatment-free periods, the animals were sacrificed and submitted to a full macroscopic examination. Designated organs were weighed and specified tissues preserved. A microscopic examination was performed on selected tissues from animals in the control and high dose groups and on macroscopic lesions from all animals killed on completion of the treatment period. The thyroids and spleen were submitted to microscopic examination for all low and intermediate dose animals at the end of the dosing period as well as for high dose animals at the end of the treatment free period.
No unscheduled deaths occurred during the study. Ptyalism, noted among almost all the animals given 100 mg/kg bw/day, was not considered as an adverse effect as it is commonly encountered when a test item is administered by gavage. There were no perturbations of the autonomic or physiological functions in any treated group. A slightly lower mean body weight gain was noted in males given 100 mg/kg bw/day during the whole dosing period and was most of the time statistically significant. Mean male body weight returned to control values during the treatment free period. No treatment related effect was noted on female body weight gain. No treatment related effects were noted on food consumption for either males or females and there were no ophthalmological treatment related findings at the end of the treatment period. No treatment related changes were noted for any haematological or blood biochemical parameters. At the end of the treatment period, the following treatment related differences from controls were observed in urinary parameters at 100 mg/kg bw/day : presence of low to high bilirubin levels in all males and in 7/10 females, traces of nitrite in 8/10 males and 6/10 females, traces of glucose in 6/10 males and 6/10 females, marked colouration of urine (from yellow to yellow-brown) in both males and females. All these changes were attributed to treatment and were no longer present on completion of the treatment free period. No treatment related effects on organ weights were noted. Brownish colouration of the thyroids was observed in all males and females given 100 mg/kg bw/day and was associated at microscopic examination with brownish pigment deposits in the thyroids. Spleen hemosiderosis was also observed for all animals given 100 mg/kg bw/day. Both these microscopic changes on thyroids and spleen were still observed at the end of the recovery period.
The test substance 2,4-diaminophenoxyethanol dihydrochloride was administered daily by gavage to Sprague-Dawley rats at the dose level of 4, 20 or 100 mg/kg bw/day for 13 weeks. At 4 and 20 mg/kg bw/day the test item was well tolerated. A 100 mg/kg bw/day, ptyalism was observed in both males and females and lower body weight gains were noted for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4 week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg bw/day on completion of treatment and treatment-free periods. Under the experimental conditions of the study, the NOEL is established to be 20 mg/kg bw/day.
Justification for classification or non-classification
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