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EC number: 221-359-1 | CAS number: 3077-12-1
- 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:
- February 28th - March 14th, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, April 2011; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued 19 May 2011
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- EC Number:
- 221-359-1
- EC Name:
- 2,2'-[(4-methylphenyl)imino]bisethanol
- Cas Number:
- 3077-12-1
- Molecular formula:
- C11H17NO2
- IUPAC Name:
- 2,2'-[(4-methylphenyl)imino]diethanol
- Reference substance name:
- 2-{[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino}ethan-1-ol
- Cas Number:
- 878391-30-1
- Molecular formula:
- C13H21NO3
- IUPAC Name:
- 2-{[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino}ethan-1-ol
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: clear, slightly yellowish to brown, viscous liquid
- Storage condition of test material: at room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean; at start males: 266-285g, females: 185-209g
- Housing: Individually housed 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): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 FEB 2013 to 14 MAR 2013
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
The test substance formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
Frequency: Single dosage, on Day 1.
Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at WIL Research and on test substance data supplied by the sponsor.
Dose volume: 2000 mg/kg (10 mL/kg) body weight
DOSAGE PREPARATION: The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. No correction was made for purity of the test substance. In order to obtain homogeneity, the test substance (formulations) were heated in a water bath with a maximum temperature of 75ºC for a maximum of 17 minutes. The test substance formulation was allowed to cool down to a temperature of maximally 40ºC prior to dosing.
Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
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: Yes
- Other examinations performed: None - Statistics:
- None.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture, piloerection and/or chromodacryorrhoea were noted in all males and three females on Days 1 and/or two. Hypothermia was noted in one male on Day 2. No signs of irritation were seen in the treated skin-area of the animals during the observa
- Gross pathology:
- Two males showed many reddish foci in the thymus and three females showed enlarged size of mandibular lymph nodes during macroscopic post mortem examination. No abnormalities were found in the other animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, a LD50 >2000 mg/kg bw was determined.
- Executive summary:
An acute dermal toxicity test was conducted with five male and five female rats following OECD and EPA guidelines according to GLP principles. Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]- was applied occlusively at 2000 mg/kg bw for 24 hours. No mortality occurred. No unexpected changes in body weight gain were reported. Hunched posture, piloerection and/or chromodacryorrhoea were noted in all males and three females on Days 1 and/or two. Hypothermia was noted in one male on Day 2. Two males showed many reddish foci in the thymus and three females showed enlarged size of mandibular lymph nodes during macroscopic post mortem examination. No abnormalities were found in the other animals.
Based on these results, the test substance has an acute LD50 > 2000 mg/kg bw and is not classified for acute dermal toxicity according to Regulation (EC) No. 1272/2008.
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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