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EC number: 948-518-4 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 January 2019 - XX November 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
- EC Number:
- 948-518-4
- Molecular formula:
- (C13H23N3O2 . C31H43N3O6)x
- IUPAC Name:
- Reaction products of 2,3-epoxypropyl phenyl ether and 2,2'-iminodi(ethylamine)
- Test material form:
- liquid
- Details on test material:
- PGE-DETA adduct
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Olin Corporation Batch: 17-09-502-04 QM 14K17-54
- Expiration date of the lot/batch: 30 October 2019
- Purity test date: Approx. 97% (including the oligomeric isomers)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: The test item formulations were prepared on the day of dosing and dosed within 1 hour of preparation.
Test Item Preparation
The test item was formulated as a clear solution at concentrations of 60 and 400 mg/mL in the vehicle and administered at a volume of 5 mL/kg body weight. Determination of the homogeneity, stability and purity of the test item or test item formulations were not undertaken.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Ltd
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 163 to 184 g
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: as groups of one or four rats per solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding.
- Diet (ad libitum): Teklad 2014C Diet
- Water (ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes
- Acclimation period: at least five days before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 and 400 mg/ml
- Justification for choice of vehicle: Test item could be dissolved into this vehicle to yield a clear solution.
- Lot/batch no. (if required): 17-09-502-04 QM 14K17-54
- Purity: 97%
MAXIMUM DOSE VOLUME APPLIED: 5ml/kg
DOSAGE PREPARATION (if unusual): The test item was formulated as a clear solution at concentrations of 60 and 400 mg/mL in
the vehicle and administered at a volume of 5 mL/kg body weight. The test item formulations were prepared on the day of dosing and dosed within 1 hour of
preparation.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females at 300 mg/kg bw and 5 females at 2000 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical Signs: Animals were observed soon after dosing and at frequent intervals (at least 0.5, 1, 2 and 4 hours after dosing) on Day 1. On subsequent days, surviving animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
Body Weight: The weight of each rat was recorded on Days -1, 1 (prior to dosing), 8 and 15 or at death.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Four females dosed at 2000 mg/kg were killed for welfare reasons on Day 1. No mortalities at 300 mg/kg bw.
- Clinical signs:
- other: No clinical signs were seen in any animal dosed at 300 mg/kg or the animal dosed at 2000 mg/kg in the sighting study. Clinical signs observed prior to death for animals dosed at 2000 mg/kg comprised reduced body temperature, piloerection, underactive beha
- Gross pathology:
- Macroscopic examination of the decedents revealed yellow liquid fluid contents in the stomach, duodenum and small and large intestines in all animals and in the caecum for 2 animals and congestion, characterized by darkened tissues/organs, in the subcutaneous tissue, brain and spleen in all animals and the stomach, duodenum and small and large intestines for three animals. The duodenum and small and large intestines were also enlarged, swollen or thickened in one animal.
No abnormalities were revealed in any animal surviving until Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of 1,2-Ethanediamine, N-(2-
aminoethyl)-,reaction products with glycidyl Ph ether was demonstrated to be between 300
and 2000 mg/kg body weight. - Executive summary:
The study was performed to assess the acute oral toxicity of 1,2 -Ethanediamine, N-(2 -aminoethyl)-, reaction products with glycidyl Ph ether, to the rat in accordance with OECD Guideline 420 and
EEC Commission Regulation No. 440/2008, Part B, Method B.1 bis.
Fasted female rats received a single oral gavage dose of the test item, formulated in PEG400 to form a clear solution, at the following dose levels:
Sighting investigations: 300 and 2000 mg/kg body weight one female rat at each dose level
Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 2000 mg/kg body weight. Due to the number of deaths in the main study at 2000 mg/kg body weight, a further four fasted females were similarly dosed at 300 mg/kg body weight to complete the study.
During the study, clinical condition, body weight and macropathology investigations were undertaken.
Results:
Four females dosed at 2000 mg/kg were killed for welfare reasons on Day 1. Clinical signs prior to death comprised reduced body temperature, piloerection, underactive behavior, blue
extremities and partially closed eyelids in all animals, hunched posture in three animals, elevated gait and irregular breathing in two animals, flat posture, gasping and shallow
breathing in two animals and a convulsion in one animal. These signs were seen from approximately two hours after dosing. Macroscopic examination revealed yellow liquid fluid
contents in the stomach, duodenum and small and large intestines in all animals and in the caecum for two animals and congestion, characterized by darkened tissues/organs, in the
subcutaneous tissue, brain and spleen in all animals and the stomach, duodenum and small and large intestines for three animals. The duodenum and small and large intestines were
also enlarged, swollen or thickened in one animal.
No clinical signs were seen in any animal dosed at 300 mg/kg or the animal dosed at 2000 mg/kg in the sighting study.
All animals were considered to have achieved satisfactory body weight gains throughout the study.
No macroscopic abnormalities were revealed in any animal surviving until Day 15.
Conclusion
The acute median lethal oral dose (LD50) to rats of 1,2-Ethanediamine, N-(2 - aminoethyl)-,reaction products with glycidyl Ph ether was demonstrated to be between 300
and 2000 mg/kg body weight. 1,2-Ethanediamine, N-(2-aminoethyl)-,reaction products with glycidyl Ph ether is included in
Category 4, according to the Globally Harmonised System (GHS).
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