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EC number: 246-307-5 | CAS number: 24544-08-9
- 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:
- April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,6-diethyl-p-toluidine
- EC Number:
- 246-307-5
- EC Name:
- 2,6-diethyl-p-toluidine
- Cas Number:
- 24544-08-9
- Molecular formula:
- C11H17N
- IUPAC Name:
- 2,6-diethyl-4-methylaniline
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): p-Ditolin
- Physical state: liquid
- Expiration date of the lot/batch: 07-October-1989
- Stability under test conditions: stable
- Storage condition of test material: room temperature, at a dry place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (Germany)
- Strain: Bor: WISW (SPF Cpb)
- Age at study initiation: Males 8 weeks and females 10 weeks
- Weight at study initiation: mean males 190 g and females 171 g
- Fasting period before study: 16 hours before treatment
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): Altromin® 1324 Pellets (manufacturer: Altromin GmbH und Co KG, Lage, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (6 hours artificial light)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Doses:
- 200, 312, 630, 1000 and 2000 mng/kg
- No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- no
Results and discussion
- Preliminary study:
- no pretest
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 443 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 630 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 312 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 200 mg/kg:
No mortality was observed in both sexes.
312 mg/kg:
No mortality was noted in males, whereas one female was found dead five days after treatment.
630 mg/kg:
Four out of five male animals were found dead between days 1 to 4 after dosing. All females died within two to three days after treatment.
1000 mg/kg and 2000 mg/kg:
All males and females died within 2 days after dosing. - Clinical signs:
- other: 200 mg/kg: Salivation and ruffled fur was noted in some animals. 312 mg/kg up to 2000 mg/kg: In addition to salivation and ruffled fur, males and females aat these dose levels showed also sedation, gasping, chromodacryorrhoe, tremor, unsteady gait and ov
- Gross pathology:
- 200 mg/kg:
One surviving male showed pale discolored kidneys.
312 mg/kg:
No treatment-related findings observed.
630 mg/kg up to 2000 mg/kg:
Aerogastria, red or black discoloured mucuous mebranes of the stomach and small intestines were noted in both sexes. Females died at 630 mg/kg also showed pale discolored livers. There were some further findings in one died male and in one surviving male.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 on Wistar rats was found to be 443 mg/kg.
- Executive summary:
The acute oral LD50 study was conducted as GLP-study according to OECD no. 401. The test was performed as full test on male and female Wistar rats with doses of 200, 312, 630, 1000 and 2000 mg/kg. Mortality occured at concentrations of 312 mg/kg and above, slight to moderate clinical symptoms were noted in almost all dose groups, body weight gain was slightly reduced in surviving males at 312 mg/kg and above. At necrospy, a number of treatment-related effects were noted, such as salivation, ruffled fur, discolored kidneys and liver etc. in all dose groups.
Therefore, based on the oral LD50 of 443 mg/kg, the test item has to be classified as harmful.
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