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EC number: 941-634-6 | CAS number: 1228284-78-3
- 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:
- 12 November 2013 to 10 December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine
- EC Number:
- 941-634-6
- Cas Number:
- 1228284-78-3
- Molecular formula:
- C10H12Cl3NO
- IUPAC Name:
- methoxy[1-(2,4,6-trichlorophenyl)propan-2-yl]amine
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Brown liquid
- Expiration date of the lot/batch: Recertification date end May 2017
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan:(WIST)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 166-203 g
- Fasting period before study: Yes
- Housing: Individually in Type II polypropylene/polycarbonate cages
- Diet: Ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" ad libitum (except overnight prior to dosing and 3 hours after dosing)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1-22.2
- Humidity (%): 35-68
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 November 2013 To: 10 December 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000, 550 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 mins, 1, 2, 3, 4, 6 hours after dosing, then once daily for 14 days (observations); days -1 (prior to removal of food), 0 (prior to administration), 7 and 14 (body weight).
- Necropsy of survivors performed: Yes - Statistics:
- Data was evaluated using the Acute Oral Toxicity (OECD Test Guidelines 425) Statistical Programme (AOT 425 Stat Pgm).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 550 - < 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 550 - 2 000
- Mortality:
- 3/3 at 2000 mg/kg bw, 0/3 at 550 mg/kg bw
- Clinical signs:
- other: Decreased activity (3/3), hunched back (2/3), prone position (3/3), incoordination (2/3), continuous tremors (3/3), piloerection (3/3), decreased respiratory rate (1/3) and cold to touch (1/3) at 2000 mg/kg bw. Hunched back (3/3), incoordination (3/3),
- Gross pathology:
- No treatment-related effects
Any other information on results incl. tables
Table 1: Mortality data
Dosing sequence / animal number |
Dose (mg kg bw) |
Outcome |
4303 |
550 |
Survived |
4304 |
2000 |
Died on day 2 |
4305 |
550 |
Survived |
4306 |
2000 |
Died on day1 |
4307 |
550 |
Survived |
4308 |
2000 |
Died on day 2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information: H302: Harmful if swallowed
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item, CA5204A, was found to be between 550 and 2000 mg/kg bw in female RccHan:(WIST) rats.
- Executive summary:
An acute oral toxicity (up and down procedure) study was conducted with 6 animals (female RccHan:(WIST) rats). The starting dose was 550 mg/kg bw. Animals were treated with a single oral (gavage) dose of CA5204A at a dose level of 550 or 2000 mg/kg bw followed by a 14 day observation period. The animals were fasted overnight prior to treatment and food was returned approximately 3 hours after dosing. Surviving animals were observed individually after dosing at 30 minutes, 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1 (prior to removal of food), Day 0 (prior to administration) and weekly thereafter. All surviving animals were examined macroscopically at the end of the observation period. Moreover, the animals found dead were examined macroscopically and body weight was recorded at necropsy. No mortality was observed at the dose level of 550 mg/kg bw. Treatment with CA5204A at the dose level of 550 mg/kg bw caused hunched back (3/3), incoordination (3/3), continuous tremors (2/3), piloerection (3/3) and hyperactivity (2/3). Surviving animals were symptom free from 8 days after the treatment. There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age. There was no evidence of the macroscopic observations in animals dosed at 550 mg/kg bw and terminated on Day 14. Mortality was observed in all three animals on Day 1 or 2 at 2000 mg/kg bw dose level. Treatment with CA5204A at the dose level of 2000 mg/kg bw caused decreased activity (3/3), hunched back (2/3), prone position (3/3), incoordination (2/3), continuous tremors (3/3), piloerection (3/3), decreased respiratory rate (1/3) and cold to touch (1/3).
Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item, CA5204A, was found to be between 550 and 2000 mg/kg bw in female RccHan:(WIST) rats.
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