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Diss Factsheets
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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Remarks:
- The study on acute dermal toxicity was conducted solely to comply with a non-EU national registration requirement, and has been provided here in accordance with REACH, Article 22(1)e.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 November 2013 to 29 November 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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 September 2015
- 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 220-257 g
- Fasting period before study: No
- 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
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7-9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7-24.3
- Humidity (%): 31-54
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 November 2013 To: 29 November 2013
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back (shaved 24 hours prior to application).
- % coverage: Approximately 10% total body surface.
- Type of wrap if used: Gauze pads kept in contact with the skin with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed, using body temperature water.
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.54 mL/kg bw (x1300 mg/mL = 2000 mg/kg bw). - 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:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 5 hours after application and once daily thereafter (observations); Day 0 (before the experiment) and on Days 7 and 14 (body weights).
- Necropsy of survivors performed: Yes. - Statistics:
- Not applicable.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: Decreased activity (3/10), hunched back (8/10), incoordination (9/10), irritability (3/10) and continuous tremors (9/10). All animals were symptom free from 7 days after the treatment. No signs of dermal irritation.
- Gross pathology:
- No treatment-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of the test substance after a single dermal administration (dermal LD50) was greater than 2000 mg/kg bw in male and female RccHan:(WIST) rats.
- Executive summary:
Five male and five female RccHan:(WIST) rats were treated with a single, 24 hour, semi occlusive dermal application of the test substance at a dose of 2000 mg/kg bw. Clinical observations along with a check of viability and mortality were assessed in all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. All animals were killed and subjected to a gross macroscopic examination at the end of the 14-day observation period (Day 14).
There was no mortality. Decreased activity (3/10), hunched back (8/10), incoordination (9/10), irritability (3/10) and continuous tremors (9/10) were seen but all animals were symptom free from 7 days after the treatment. No treatment related skin irritation was observed in any animal throughout the study. Slight body weight loss was noted in one male rat and four female rats between Days 0 and 7. Bodyweights of these animals had recovered by the end of the observation period. There was no evidence of the any observations at a dose level of 2000 mg/kg bw at necropsy.
The median lethal dose of the test substance after a single dermal administration (dermal LD50) was greater than 2000 mg/kg bw in male and female RccHan:(WIST) rats.
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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