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Diss Factsheets
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EC number: 448-170-9 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 06 February 2003; Experiment completion date - 04 March 2003; Study completion date - 13 March 2003.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identity: FAT 40’810/A
Description: Brown solid
Batch number: WP 6/02
Expiry date: 12-DEC-2009
Purity: approx. 75.0%
Stability of test item dilution: For at least 7 days in water at room temperature.
Storage conditions: In the original container, at room temperature (range of 20 ±3 °C, provided at RCC Ltd), away from direct sunlight.
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40810/A
Batch: WP 6/02
Purity: approx. 75 %
Appearance: Solid, dark brownish powder
Expiration date: 12 December 2010
Storage: At room temperature at about 20 °C
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test system: Rat, HanBrl: Wist (SPF)
Rationale: Recognized by the international guidelines as a recommended test system.
Source: RCC Ltd, Biotechnology and Animal Breeding, CH-4414 Füllinsdorf / Switzerland
Number of animals per group 3 males and 3 females
Total number of animals 3 males and 3 females
Age when treated: Males: 8 weeks, Females: 12 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked immediately prior to treatment.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Husbandry: Room no. 104/ RCC Ltd, Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10 – 15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 ± 3 °C and for relative humidity between 30 - 70 % (values above 70 % during cleaning process possible), 12 hours fluorescent light 12 hours dark, music during the light period.
Accommodation: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 67/02 (Provimi Kliba AG, CH-4303 Kaiseraugst Switzerland) ad Iibitum. Results of analyses for contaminants are archived at RCC Ltd, ltingen.
Water: Community tap water from Füllinsdorf ad Iibitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, ltingen.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for 17 to 19 hours (access to water was permitted). Food was provided again 3 hours after dosing. The application volume was 10 ml/kg body weight.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females and 3 males
- Control animals:
- no
- Details on study design:
- The study strictly followed the OECD 423 toxic class methodology and in lack of mortality and other effects at 2000 mg/kg bw no further doses were tested. Animals were observed for 15 days following dosing for mortality/viability (daily), body weight (prior to administration, on days 8 and 15) and clinical signs (daily). Following the observation period, the animals were killed by intraperitoneal injection and macroscopic examinations were performed.
- Statistics:
- No statistics was applied in lack of symptoms/mortality.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: No clinical signs were observed during the course of the study. No deaths occurred during the study. CLINICAL SIGNS: No clinical signs were observed in any animals. BODY WEIGHTS: The body weight of all animals was within the range commonly
- Gross pathology:
- Effects on organs: No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute LD50 (oral, rat) of FAT 40810/A: >2000 mg/kg bw
An acute oral toxicity study was conducted in accordance with OECD test guideline 423 and EEC B.1 to assess toxicity of FAT 40810/A upon single administration. - Executive summary:
An acute oral toxicity study was conducted in accordance with OECD test guideline 423 and EEC B.1 to assess toxicity of FAT 40810/A upon single administration. Three male and three female HanBrl: WIST (SPF) rats were treated with FAT 40810/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of FAT 40810/A after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight.
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.
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