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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 March 2018 - 23 April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Specific details on test material used for the study:
- Stability in vehicle: The test item is stable in a solution of Propylene glycol for at least 5 hours at room temperature under normal laboratory conditions, for at least 6 days in the refrigerator and, for at least 3 weeks in the freezer (≤ -15°C) over the concentration range 1 to 200 mg/mL.
The test item was heated to approximately 80°C for 15 minutes approximately 2 hours before weighing.
Adjustment was made for specific gravity of the vehicle (1.036).
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(Han)
- Remarks:
- Outbred, SPF-Quality
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant:yes
- Age at study initiation: approx. 9 - 12 weeks old
- Weight at study initiation: 166-212 g.
- Housing: Group housing (up to 5 animals of the same sex together) on arrival and individual housing during the study. Polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust were used during the study. For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom), except when interrupted by study procedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum throughout the study, except during designated procedures.
- Water: Municipal tap-water, ad libitum
- Acclimation period: 5 days
The feed was analyzed by the supplier for nutritional components and environmental contaminants. It is considered that there were no known contaminants in the feed that would interfere with the objectives of the study.
Periodic analysis of the water was performed, and it is considered that there were no known contaminants in the water that would interfere with the objectives of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 30-51
- Air changes (per hr): >= 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 March 2018 To: 23 April 2018
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- propylene glycol
- Remarks:
- Specific gravity: 1.036
- Details on dermal exposure:
- RANGEFINDING STUDY
A range finding study was performed in order to select the dose causing no mortality or significant toxicity to be used in the main study. Initially, one animal was dosed at 1000 mg/kg. A period of at least 48 hours was allowed between the dosing of each animal. Based on the results one additional animal was dosed at 2000 mg/kg. Based on the results of the range finding study, in the main study two animals were dosed at 2000 mg/kg.
TEST SITE
- Area of exposure: 18 cm^2
- % coverage: approx. 10% of the total body surface
- Type of wrap if used: The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages/
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 1000 & 2000 mg/kg bodyweight
- Constant volume or concentration used: yes, 10 mL/kg bodyweight - Duration of exposure:
- 24 hours
- Doses:
- 1000 mg/kg bodyweight
2000 mg/kg bodyweight - No. of animals per sex per dose:
- 1 female: 1000 mg/kg bodyweight
3 females: 2000 mg/kg bodyweight - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: twice daily; Clinical observations: at periodic intervals on the day of dosing (at least three times) and once daily thereafter; Body weights: on day 1 (pre-administration), day 8 and day 15.
- Necropsy of survivors performed: yes
The skin reactions were assessed approximately 24, 48 and 72 hours after the removal of the dressing and test item. Adjacent areas of untreated skin of each animal served as controls.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Red discoloration of the nose and ptosis were noted for one animal on Day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- Irritation and local effects:
No erythema or edema were scored for any of the animals at any time point. Fissures, scales, scabs and/or red discoloration were seen in the treated skin-area of the animals between Days 2 and 15. Scabs were noted on the back of one animal between Days 12 and 15.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The dermal LD50 value of Ethanol, 2,2’-[(3-methylphenyl)imino]bis- in Wistar rats was determined to exceed 2000 mg/kg body weight. Based on this result, Ethanol, 2,2’-[(3-methylphenyl)imino]bis- is not classified according to GHS and CLP criteria.
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