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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 916-222-4 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
LD50 (rat) > 25 000 mg/kg bw/day
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1956 December
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: The toxicity of test substance has been studied using rats in acute and subacute oral studies, guinea pigs in the skin irritation and sensitization tests. A limited patch tet has been run with eighteen human subjects.
- Short description of test conditions: The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance.
- Parameters analysed / observed: clinical and pathological signs have been observed - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TLF-945-B
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: low solubility
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not observed
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 16 hours light and 8 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100, 0.75 and 0.5
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not specified
Maximum dose applied: 25000 mg/kg
DOSAGE PREPARATION (if unusual): The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance.
- Rationale for the selection of the starting dose: not specified - Doses:
- the two highest dose levels are 17000 mg/kg and 25000 mg/kg.
- No. of animals per sex per dose:
- not specfied
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 9-13 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD100
- Effect level:
- > 25 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- not observed
- Clinical signs:
- other: slight diarrhea at the second highest dose and severe dirrhea at the highest dose
- Gross pathology:
- no pathological changes were noted
- Other findings:
- - Organ weights: not specififed
- Histopathology: no pathological changes were noted
- Potential target organs: not specified
- Other observations: no other observations - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tests of acute and subacute oral toxicity showed that the substance is of a very low order of oral toxicity hence the GHS criteria for classification has not been met.
- Executive summary:
By stomach tube administration to the albino rats, the approximate lethal dose of test item was found to be greater than 25 000 mg/kg bw. The only clinical signs observed were severe diarrhea at the highest level tested and slight diarrhea at the next level, 17 000 mg/kg bw. No pathological changes were noted when the animals were sacrified 9 to 13 days after treatment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 25 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity study in rats was conducted to assess the toxicological profile of the test item. Undiluted test item as supplied by the stomach tube to male albino rats. No pathologial changes were note at sacrifice D9 - D13.
Justification for classification or non-classification
No classification according to CLP regulation is warranted.
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.