Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-706-8 | CAS number: 851-68-3
- 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:
- 2 001
- Report date:
- 2001
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:
- no
Test material
- Reference substance name:
- 2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
- EC Number:
- 212-706-8
- EC Name:
- 2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
- Cas Number:
- 851-68-3
- Molecular formula:
- C19H24N2OS
- IUPAC Name:
- 2-methoxy-N,N,β-trimethyl-10H-phenothiazine-10-propylamine
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP Ltd. (Budapest, H1103, Cserkesz street 90.)
- Age at study initiation: 7 weeks
- Fasting period before study: overnight (after the test item administration food was withheld for 3 hours)
- Housing: 3 animals / cage in MAKROLON II type cages. (37x29x19 cm)
Cages with bedding were steam-sterilized at 121 °C for 20 minutes.
- Bedding: LIGNOCEL type (steam-sterilized) pure soft woodcut
- Diet (e.g. ad libitum): ad libitum, CRLT / N standard diet for rodent (Szinbád Kft.)
- Water (e.g. ad libitum): ad libitum, potable water, offered daily in MAKROLON type drinking bottles sterilized before use
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.6 -24.3 °C
- Humidity (%): 37.6-68.7 %
- Air changes (per hr): 10-15 / h
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % aqueous methylcellulose
- Details on oral exposure:
- VEHICLE 1% aqueous methylcellulose
- Concentration in vehicle: 2000 mg / 20 ml suspension and 200 mg / 20 ml suspension
- Amount of vehicle (if gavage): 20 ml / kg bw.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg / kg bodyweight - Doses:
- 2000 mg / kg in female rats (n=3)
200 mg / kg in male and female rats (n=3-3) - No. of animals per sex per dose:
- 3 females and 3 males (200 mg/kg)
3 females (2000 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : for 6 hours after treatment and then twice a day
and weighing just before treatment, after 24 hours, on the 8th and 14th day
- Necropsy of survivors performed: yes (macroscopic)
- Other examinations performed: individual observations included the status of skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic, central nervous system and somatomotor activity as well
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 200 - 2 000 mg/kg bw
- Mortality:
- Three females died (3/3) after 2000 mg/kg dose of the test item.
- Clinical signs:
- Serious CNS depressive symptoms (somnolence and dyspnea in 10 minutes) occured in the 2000 mg/kg female dose group. All of the animals died inthis dose group in the first 48 hours. Animals in the 200 mg/kg dose groups show somnolence after treatment. One day after treatment with 200 mg/kg test item animals became symptom-free.
- Body weight:
- The mean body weights decreased in the 200 mg/kg dose groups on the 2nd day of the study. After this the mean body weights and body weight gain changed in a similar manner in the 200 mg/kg dose groups that expected from control animals of the same age and strain in both sexes.
- Gross pathology:
- In the females, died on study, gross pathology revealed acute circulatory inefficiency and gastrointestinal disturbances (mottled lungs with haemorrhages, stomach and intestines filled with gaseous fluidy content, congestioned mucosa of gastrointestinal tract) as the cause of death. No pathological macroscopic findings could be detected at terminal sacrifice.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions the approximate calculated LD50 value of the RACEM TISERCIN BASE, administered by oral route to Wistar rats was between 200 and 2000 mg/kg so according to the requirements of the Minister of Health 44/2000(XII.27) EÜM regulation the test item was classified to LD50:> 200-2000 mg/kg Xn Harmful category.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.