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EC number: 807-655-9 | CAS number: 1629160-48-0
- 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 acute oral median lethal dose (LD50) of FAT 92'267/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
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:
- 3 April 1991 to 24 April 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
EN 3.86
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at room temperature
- Stability under storage conditions: stable for at least 2 hours in water
- Stability under test conditions: unknown - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 8 weeks and females: 10 weeks
- Weight at study initiation: Males: 182-209 g and females: 173-182 g
- Fasting period before study: Fasted for 16 to 22 hours before gavage.
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding.
- Diet: Pelleted standard Kliba 343, Batch 83/91 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination.
- Identification: By unique cage number and corresponding color-coded spots on the tail.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): Air conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark and music during the light period. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- The animals received a single dose of the test article on a mg/kg body weight base by oral gavage after being fasted for 16 to 22 hours (access to water was not interrupted). Food was again presented approximately 3 hours after dosing. Application Volume: 10 ml at 2000 mg/kg.
Rationale: The oral administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article. - Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Observations mortality/ Viability: Four times during test day 1 and daily during days 2-15
- Observations body weight: Test days 1 (pre-administartion), 8 and 15.
- Necropsy of survivors performed: yes. All animals were euthanized by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- The LOGIT-Model could not be applied to the observed rates and death. The toxicity was estimated without use of a statistical model.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other: There were no clinical signs were observed except sedated, hunched posture, ruffled fur in one male animal on day one.
- Gross pathology:
- No obvious macroscopical organ findings noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of FAT 92267/A in rats of both sexes was estimated to be greater than 2000 mg/kg.
- Executive summary:
The acute oral toxicity study was carried out to assess the toxicological profile of FAT 92267/A when administered to rats by single oral gavage, with an observation period of 15 days according to OECD Guidelines 401 and EU method B.1. The experiment was done on five males and 5 females rats. The test article FAT 92267/A was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg. There were no mortality found. There were no clinical signs were observed except sedated, hunched posture, ruffled fur in one male animal on day one. The body weight gain of the animals was not affected by the test article treatment throughout the entire study period. There were no obvious macroscopical organ findings noted. Based on the study results, the acute oral median lethal dose (LD50) of FAT 92267/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD guideline and GLP compliance study
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
Acute toxicity: oral
The acute oral toxicity study was carried out to assess the toxicological profile of FAT 92267/A when administered to rats by single oral gavage, with an observation period of 15 days according to OECD Guidelines 401 and EU method B.1. The experiment was done on five males and 5 females rats. The test article FAT 92267/A was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg. No mortality was found. There were no clinical signs were observed except sedated, hunched posture, ruffled fur in one male animal on day one. The body weight gain of the animals was not affected by the test article treatment throughout the entire study period. There were no obvious macroscopical organ findings noted. Based on the study results, the acute oral median lethal dose (LD50) of FAT 92267/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.
Acute toxicity: inhalation
Currently no study to assess the acute inhalation toxicity potential of FAT 92267 is available. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected. FAT 92267 is used as an intermediate only and as such will be used in closed processes. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50: >2000 mg/kg bw), with no mortality or systemic toxicity being seen, hence it does not need to be classified as STOT SE, further supporting the conclusion that it is expected to have low toxicity via the inhalation route. Taking, the above information into consideration, the inhalation toxicity test for FAT 92267 was considered scientifically not necessary.
Acute toxicity: dermal
Currently no study to assess the acute dermal toxicity potential of FAT 92267 is available. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute dermal toxicity only needs to be conducted if an exposure via dermal route is to be expected. FAT 92267 is used as an intermediate only and as such will be used in closed processes. Hence, the use of this substance will not result to dermal exposure of the workers. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50: >2000 mg/kg bw), with no mortality or systemic toxicity being seen, hence it does not need to be classified as STOT SE,Similarly, absence of systemic toxicity in skin irritation and sensitisation studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Taking into consideration the above arguments, low toxicity is expected on acute dermal exposure ofFAT 92267 and testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Based on the observed LD50 of >2000 mg/kg bw in the acute oral toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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