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Diss Factsheets
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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
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.The Relevant dose descriptor: NOAEL: 20 mg/kg/bw Route to route extrapolation: NOAEC = NOAEL x (1/sRV(rat)) x (sRVhuman/wRV) x (ABSoral/ABSinhal.)
NOAEC = 20 mg/kg/day x (1/0.38 m3/kg/bw) x (6.7 m3/10 m3) x (50%*/100%) = 17.63 mg/m3
*oral bioavailability unknown and by default supposed to be 50%, inhalation bioavailability is supposed to be 100%.
The relevant dose descriptor: long term NOAEC = 17.63mg/m3
The Assessment factor = 1 x 2.5 x 5 x 2 x 1 x 1 = 25
Worker-DNEL long term inhalation systemic= 0.7 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- default value for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation from oral to inhalation route (example B3 of guidance R8)
- AF for other interspecies differences:
- 2.5
- Justification:
- R8 ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.81 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 595.24 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
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.
The Relevant dose descriptor: NOAEL: 20 mg/kg/bw Route to route extrapolation: NOAEL = NOAEL x (ABSoral/ABSdermal)
NOAEL = 20 mg/kg/day x (50%*/1.68%) = 595.24 mg/kg bw/d
*oral bioavailability unknown and by default supposed to be 50%, dermal bioavailability is determined to be 1.68%.
The relevant dose descriptor: long term NOAEL = 595.24 mg/kg bw/d
The Assessment factor = 1 x 2 x 4x 2.5 x 5 x 1 x 1 = 100
Worker-DNEL long term dermal systemic= 23.81 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- for extrapolation subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (Rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- from LOAEL to NOAEL minimum/majority case
- AF for differences in duration of exposure:
- 1
- Justification:
- default value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value systemic effect
- AF for other interspecies differences:
- 1
- Justification:
- default value local effect or for effects on skin, eye and GI tract via simple destruction of membranes
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- from LOAEL to NOAEL minimum/majority case
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value systemic effect
- AF for other interspecies differences:
- 1
- Justification:
- default value local effect or for effects on skin, eye and GI tract via simple destruction of membranes
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The CSR need not include consideration of the risks to human health from the end use of cosmetic products within the scope of Regulation EC 1223/2009.
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.