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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 483-270-6 | CAS number: 54068-28-9
- 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
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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD nø 423 (24 April 2002) Test method B.1tris directive 2004/73/EC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interminsteriel Des Produits Chimiques, Paris, France
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- other: no vehicle
- Doses:
- Control: 2 ml/kg bw distilled water
Treated: 1,79 ml/kg bw TIB KAT 223 ( = 2000 mg/kg bw) - No. of animals per sex per dose:
- Control: 6
Treated: 6 - Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Mortality:
- Female: CA 2000 mg/kg bw; Number of animals: 3; Number of deaths: 1
Female: CA 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: It was registered in the treated animals, from 30 minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with an absence of Preyer's reflex (5/6), a bradypnea (6/
- Gross pathology:
- Effects on organs:
The macroscopical examination of the animal which died
during the study revealed the presence of
black spots at the level of the corpus.
The macroscopical examination of the animals at the end of
the study did not reveal treatment-related
changes. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, the LD_{50} of the test item TIB KAT 223 is 2500 mg/kg bw in the oral route in the rat.
-> EEC/67/548: no classification, no symbol and risk phrase
-> 1272/2008/EC: must not be classified in Cat.4, no signal word and hazard statement are required.
Remark: Classification in the UN GHS System is Cat.5
Reference
It was noted the dead of one of treated rat, 48 hours after the test item adnministration.
It was registered in the treated aninmals, from 30 miniutes after the test item administration, a decrease of spontanous acitvity (6/6) assoziated with an absence of Preyer´s reflex (5/6), a bradypneu (6/6), a decrease of muscle tone (5/6), the eyes partly closed (5/6), an increase of lachrymation (3/6), a decrease or an absence of righting reflex (5/6), tremors (2/6) an a piloerection (6/6). The animals recovered a normal activity between the 2nd day and the 3rd day of the test.
A deacrease of the body weight gain was noted in all treated animals, 48 hours after the test item administration. Then the body weight evolution of the animals remsined normal similar between treated and the controll animals.
The macroscopical examination of the animal which died during the study revealed the presend of black spots at the level of the corpus.
The macroscopical examination of the animals of the end of the study did not reveal tredment-related changes.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2011
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- 1.9 mL/kg of the TIB KAT 223 liquid corresponds to 2000 mg/kg.
- No. of animals per sex per dose:
- limit test with 2000 mg/kg bw, 5 male, 5 female
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dermal dose value (LD50) of TIB KAT 223 in rats is greater than 2000 mg/kg body weight in this study
- Executive summary:
Acute dermal toxicity testing of TIB KAT 223 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.
There were no deaths and no test article-related clinical signs observed in this study.
The skin of the rats showed no test article-related signs of irritation.
Body weight loss occurred in all males from Day 1 to Day 4 treated with TIB KAT 223. Females showed reduced body weight gain within this time frame. From Day 4 onwards the body weight development normalized for both male and female rats and body weight gains were comparable to pretest values.
Food consumption was reduced in males and females, respectively, from Day 1 to Day 4; thereafter, food consumption was normalized andranged in the range of pretest values and beyond that.
The animals euthanized and necropsied at the end of the observation period showed no macroscopically visible organ changes.
Reference
Mortalityand clinical signs
There were no deaths in this study. There were no test substance-related clinical sings.
Body weight
Individually body weight loss occurred in all males at 2000 mg/kg ranging from -28 g to -9 g from Day 1 to Day 4.
Females at 2000 mg/kg did not gain body weight between Day 1 and Day 4: Individual body weight changes in that time frame ranged from -2 g to +2 g. According empirical and pretest data for rats at this age in general body weight gains had to be expected (female pre-test values: 0 to +11g body weight gain).
From Day 4 onwards the body weight development normalized for male and female rats and individually body weight gains was comparable to pretest values
Food consumption
Food consumption was reduced at 2000 mg/kg by -23% to -24% in males and -15% to -19% in females compared to pretest values.
From Day 4 onwards the food consumption normalized for male and female ratsand ranged in the range of pretest values and beyond that.
The impaired body weight development/body weight loss and food consumption in the first week of the study is considered to be test compound-related.
Macroscopic observations
The animals euthanized and necropsied at the end of the observation period showed no macroscopically visible organ changes.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
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.