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EC number: 202-114-8 | CAS number: 91-99-6
- 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:
- 06 Jun 2017 - 04 Jul 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines
- Version / remarks:
- 2000, including the most recent revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-(m-tolylimino)diethanol
- EC Number:
- 202-114-8
- EC Name:
- 2,2'-(m-tolylimino)diethanol
- Cas Number:
- 91-99-6
- Molecular formula:
- C11H17NO2
- IUPAC Name:
- 2-[(2-hydroxyethyl)(3-methylphenyl)amino]ethan-1-ol
- Test material form:
- other: Colourless solidified melt
- Details on test material:
- Expiry date: 25 October 2018
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 8-9 weeks old).
- Weight at study initiation: Body weight variation was 152gr to 186gr.
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours).
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 – 22
- Humidity (%): 45 - 68
- Air changes (per hr): ten or greater.
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 June 2017 to 04 July 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- GAVAGE METHOD: plastic feeding tubes.
Frequency: single dosage, on Day 1.
VEHICLE:
Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure.
Propylene glycol was the vehicle of choice.
Specific gravity: 1.036
MAXIMUM DOSE VOLUME APPLIED:
(10 mL/kg) body weight.
DOSAGE PREPARATION: Test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations were kept at room temperature until dosing. The dosing formulations and vehicle were stirred until and during dosing.
Adjustment was made for specific gravity of the vehicle and test item. No correction was made for the purity/composition of the test item.
Any residual volumes were discarded. - Doses:
- 2000 mg/kg body weight
300 mg/kg body weight - No. of animals per sex per dose:
- 2000 mg/kg body weight: 3
300 mg/kg body weight: 6 (2 groups of three females in a stepwise manner) - Control animals:
- no
- Details on study design:
- The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg/kg body weight. Based on the results, two additional groups were dosed at 300 mg/kg body weight.
Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Duration of observation period following administration: 14 days.
- Frequency of observations: Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
Mortality/Viability: twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: All moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.
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:
- At 2000 mg/kg body weight, two animals were sacrificed for humane reasons on Day 1.
At 300 mg/kg body weight, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg body weight, comatose state, lethargy, flat posture, abnormal posture, lateral recumbency, uncoordinated movements, hunched posture, rales, piloerection, watery discharge from the eyes, ptosis, brown coloration of urine and/or hypothermia we
- Gross pathology:
- At 2000 mg/kg body weight, gelatinous contents of the gastrointestinal tract (stomach, duodenum and/or jejunum) and reddish contents of the urinary bladder were found in the animals sacrificed for humane reasons during the study, at macroscopic post mortem examination. No abnormalities were found in the remaining animal. At 300 mg/kg body weight, no abnormalities were found at macroscopic examination
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 value of ethanol, 2,2’-[(3-methylphenyl)imino]bis- in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
According to CLP and GHS regulations the subtstance is classified as category 4, labelled with H302, (harmful if swallowed). - Executive summary:
An assessment of acute oral toxicity with ethanol, 2,2’-[(3-methylphenyl)imino]bis- in the rat (Acute Toxic Class Method) was performed according to OECD/EC test guidelines and GLP principles.The test item was administered by oral gavage to one groups three female Wistar rats at 2000 mg/kg body weight. Two animals were sacrificed for humane reasons on Day 1. At day 1 comatose state, lethargy, flat posture, abnormal posture, lateral recumbency, uncoordinated movements, hunched posture, rales, piloerection, watery discharge from the eyes, ptosis, brown coloration of urine and/or hypothermia were noted for the animals. Additionally, the surviving animal showed hunched posture and piloerection on Days 2 and/or 3. Based on the results, two additional groups were dosed at 300 mg/kg body weight. At 300 mg/kg body weight, no mortality occurred but hunched posture, piloerection and/or ptosis were noted for all animals on Day 1.
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
At 2000 mg/kg body weight, gelatinous contents of the gastrointestinal tract (stomach, duodenum and/or jejunum) and reddish contents of the urinary bladder were found in the animals sacrificed for humane reasons during the study, at macroscopic post mortem examination. No abnormalities were found in the remaining animal. At 300 mg/kg body weight, no abnormalities were found at macroscopic examination.
The oral LD50 value of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- in Wistar rats was therefore established to be within the range of 300-2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.
Based on these results, Ethanol, 2,2’[(3-methylphenyl)imino]bis- is classified according to CLP and GHS regulations the subtstance is classified as category 4, labelled with H302 , (harmful if swallowed).
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