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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
Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 401 and in compliance to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- other: Single dose acute toxicity study
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, France
- Age at study initiation: ~6 weeks old
- Weight at study initiation: 195+/-3g for males and 156+/-6g for females
- Fasting period before study: ~18 hours before dosing
- Housing: Polycarbonate cages (48cm x 27cm x 20cm)
- Diet (e.g. ad libitum): All animals had free access to A04C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): Drinking water filtered by FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): ~12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: On day 15 (1998-07-09) all surviving animals were killed by carbondioxide asphyxiation - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10w/v%
- Amount of vehicle (if gavage): <10 ml/kg
- Justification for choice of vehicle: solubility
- Lot/batch no. (if required): 0101297 (test item)
- Purity: 99.6% (test item) - Doses:
- 1000 mg/kg bw
- No. of animals per sex per dose:
- One group of 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 30min, 1, 2, 4, 6hours, days 2-15 (clinical signs); days 1, 8, 15 (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination of main organs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A single dose of 1000 mg/kg bw induced death in 1/5 male and 3/5 female rats.
- Clinical signs:
- other: Hypoactivity or sedation and piloerection were noted in all animals on day 1. Lateral recumbency and tonic-clonic convulsions were also observed in two animals on day 1, one of these animals was found dead a few hours later. One male and two females were
- Gross pathology:
- No apparent abnormalities were observed at necropsy in all animals.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats.
- Executive summary:
The acute oral toxicity of the substance was assessed according to OECD 401 in compliance to GLP. Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is classified as harmful if swallowed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
For level 10-100 tpy, under REACh, a second route, after the oral should be tested for the acute toxicity: inhalation or dermal route.
Considering the form of the substance: a solid powder. Inhalation could be considered. The particle size distribution of the test item 2-(2,4-diaminophenoxy)ethanol dihydrochloride was determined using a Malvern Instruments Laser Particle Sizer with a dry powder feed system. The median particle diameter was calculated to be 39µm (> 5µm). Hence, the exposure by inhalation of the powder form is expected to be very low. Furthermore, the substance is formulated in cosmetic whitout sprayed application, any toxicological relevance of air-born particles/droplets is not expected. The dermal route should be considered for the second route of exposure under REACh regulation.
The dermal route should be considered for the second route of exposure under REACh regulation. Since 2009, the performance of animal tests for those chemicals which are intended to be used in cosmetic products (like this hair dye) is not any longer allowed in the EU. To avoid any negative impact on the intentional use of this chemical, to avoid unnecessary additional animal tests and due to the unlikelihood to get more severe labelling on acute toxicity, any additional testing on acute toxicity was avoided. A route to route extrapolation is proposed from oral route to dermal route: To assess the acute dermal toxicity of 2,4-Diaminophenoxyethanol dihydrochloride, a route to route extrapolation was proposed: Study used for the determination of acute toxicity of 2,4-Diaminophenoxyethanol dihydrochloride: Acute Oral Toxicity study result (X. Manciaux. 2952: Acute Oral Toxicity in Rats. CIT Study No. 17303 TAR, 1998) LD50 oral: Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats. 1000mg/kg bw in the rat. Toxicokinetic study results in Sprague Dawley rats: Dose levels: Bioavailability, assuming 50% Oral (default value recommended by Dermal dosing: 1.1 % Extrapolation from oral to dermal: LD 50 oral: 1000 mg/kg bw Oral Bioavailability = 50% Determination of the correction factor oral vs. inhalation route: 50% oral vs. 1.1% dermal = 45.45 LD50 calc dermal: 1000 mg/kg bw x 45.45 = 45 450 mg/kg bw
Justification for classification or non-classification
The acute oral toxicity of the substance was assessed according to OECD 401 in compliance to GLP. Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is classified as harmful if swallowed.
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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