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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-536-1 | 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
The key study was a guideline acute toxicity study conducted in accordance with GLP principles
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:
- 26 September 1991 - 31 October 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Fully adequate for assessment. Conducted according to OECD TG 401 Acute Oral Toxicity, which was removed from the OECD Test Guidelines Programme in 2001, the GLP compliant study is considered reliable according to OECD 420, EU B.1bis (Commission directive 2004/73/EC).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8741 Sulzfeld
- Weight at study initiation: males 240-260g; females 175-216g
- Fasting period before study: animals were fasted for 16 hours before the study, until 3-4 hours after administration of the test article
- Diet: ab libitum Ssniff-R Alleindiat pellets
- Water: ab libitum
- Housing: Macrolon type III collective cage housing (maximum of 5 per cage)
- Acclimation period: 5-days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±3 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light):12 hours dark: 12 hours light
- Illumination: 120 lux artificial lighting 7.00am to 7.00pm - Route of administration:
- oral: gavage
- Vehicle:
- other:
- Details on oral exposure:
- VEHICLE: undiluted in a volume of 1.89 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg - Doses:
- A preliminary range finding test with a dose of 2000 mg/kg bw was conducted in two female rats. No pre-terminal deaths were observed in the 14-day study period.
Dose was fixed at 2000 mg/kg bw - No. of animals per sex per dose:
- 5 males and 5 females in the main study
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded immediately before treatment (day 0) and on days 7 and 14 (termination)
- Necropsy of survivors performed: animals were sacrificed by CO2 asphyxiation after 14 days and gross pathological examinations were performed.
- Other examinations performed: clinical observations (Irwin-Screening Procedure) were examined at time intervals of: 10 minutes; 1 hour; 2 hour; 3.5 hour; 6 hour; 24 hour; and thereafter once daily upt to day 14. - Preliminary study:
- A preliminary range finding test with a dose of 2000 mg/kg bw was conducted in two female rats. No pre-terminal deaths were observed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the course of the study
- Clinical signs:
- Severe clinical signs, such as reduced activity, abnormal gait, abdominal, lateral or squatting position, piloerection, reduced tone and skin turgor, reduced ear reflex, reduced respiratory rate and reduced audition, were observed up to 6 hours post administration. Signs were mainly in males.
- Body weight:
- Weight gains were normal in all animals
- Gross pathology:
- Gross pathological examination at terminal necrospy (day 14) revealed no test article-dependent findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No pre-terminal deaths were observed in the OECD 401 Acute Toxicity study. Thus, the oral LD50 value is >2000 mg/kg bw. There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk mitigation measures (RMM).
- Executive summary:
The acute oral toxicity of TCD-M-acetate was investigated in male and female Wistar rats (n=10). On the basis of preliminary testing results, animals were give a single oral administration of 2000 mg/kg bw TCD-M-acetate. Clinical signs, such as reduced activity, abnormal gait, abdominal, lateral or squatting position, piloerection, reduced tone and skin turgor, reduced ear reflex, reduced respiratory rate and reduced audition were observed up to 6-hours post-administration. No pre-terminal deaths were observed in the study, consequently, an LD50could not be established. In accordance with the requirements of the limit test, the LD50value is considered to be >2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted in accordance with the principles of Good Laboratory Practice in both male and female animals
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
Justification for classification or non-classification
Since there were no deaths observed in the study or any significant clinical observations of toxicity up to the limit dose of 2000 mg/kg body weight, no classification is necessary under the UN GHS regulations
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.