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EC number: 611-205-5 | CAS number: 5486-79-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate
- Cas Number:
- 5486-79-3
- Molecular formula:
- C12H20ClNO5
- IUPAC Name:
- 2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT.
- Females (if applicable) nulliparous and non-pregnant: [yes/no] yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 190-194 g
- Housing: group caging (3 animals/cage)
- Diet (e.g. ad libitum): ssniff SM R/M-Z+H complete diet for rats, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 and 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12-12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2*3 females (2000 mg/kg)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter; the body weights were recorded on day 0, on day 7 and on day 15
- Necropsy of survivors performed: yes on Day 15
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No death occurred at 2000 mg/kg bw single oral dose of 3,4-O-dimehyl methyldopa monohydrochloride monohydrate (DMAKS). All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- other: In group 1 and 2 treated with 2000 mg/kg bw dose no treatment related symptoms were observed throughout the 14-day post treatment
- Gross pathology:
- All animals treated with 2000 mg/kg bw dse survived until the scheduled necropsy on Day 15. Severe hydrometra was observed in female No.: 6207 of the group 1 nad moderate hydrometra was detected in animal No.: 6229 of group 2. Hydrometra os physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw dose.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The method used is not intended to allow the calcuation of a precise LD50 value. The test item is ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423. as unclassified.
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