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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-500-8 | CAS number: 204277-61-2
- 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 toxicity study was performed to assess the acute oral toxicity of the test item in rat HanIbm: WIST (SPF).
The acute dermal toxicity study was performed to asses the acute dermal toxicty of the test item, (FAT 41024/B TE), in rat HanIbm: WIST (SPF).
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:
- 22 December 1998 to 14 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP methodology followed and OCED guideline 423 used to performed the experiment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- Species:
- rat
- Strain:
- other: Rat HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 8 weeks (male) and 10 weeks ( female)
- Body weight rage when treated: 200.7-214.8 g (male) and 176.6-184.2 (female)
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Acclimatization: 7 days week under laboratory conditions, after health examination.
- Diet: ad libitum
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%):40-70%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hour light and 12 hour dark, music was palyed for approximately 8 hours during the light period. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- (PEG 300)
- Details on oral exposure:
- Test article preparation:
The test article was placed into a glass beaker on a tared Mettler PG 503-S balance and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a glass rod and magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment. The preparation was made shortly before each dosing. - Doses:
- Dose / kg body weight: 2000 mg
Application volume / kg body weight: 10 ml - No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Four times during test day 1 and once daily during days 2-15
Body weight: On test day 1 (pre-administartion), 8 and 15.
Clinical signs: Each animal was examined for changing in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were reccorded.
- Necropsy of survivors performed: yes Necropsy were performed by experineced prosectors. At the end of teh observation period all animals were sacrified by intrperitoneal injection of NARCOREN at a dose of at least 2.0ml/kg body weight (equivalent to at least mg sodium pentobarbitone/kg body weght)
- Other examinations performed: clinical signs, body weight. - Statistics:
- No statistical analysis was used as no deaths occured.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured during the study
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50 is greater than 2000 mg/kg. - Executive summary:
The purpose of this study was to assess the acute oral toxicity of FAT 41024/B when administred by single oral gavage to rats, followed by an observation period of 14 days.
The experiment was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
Two groups , each using three male or three female HanIbm: WIST (SPF) rats, were treated with FAT 41024/B at 2000 mg/kg by oral gavage.
The test article was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administred at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15.
Mortaliy/Viability were reccorded together with clinical signs at the same time intervals. Body weight were recorded on day 1 prior to administartion and on day 8 and 15.
All animals were necropsied and examined macroscopically.
No deaths occured during the study.
No clinical signs of toxicity were observed during the study period.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
No macroscopic findings were observed at necropsy.
In conclusion, The median lethal dose of FAT 41024/B after single administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured. LD50 is greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 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:
- 20 January 1999 to 10 February 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP methodology followed and OCED guideline 402 used to performed the experiment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Switzerland
- Age when treated: 9 weeks (male) and 12 weeks (female)
- Body weight rage when treated: 230.9-246.8 g (male) and 193.5-206.1 g (female)
- Identification: By unique cage number and corresponding color-coded spots on the tail.
- Acclimatization: 7 days under laboratory conditions, after health examination.
- Diet: ad libitum
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%):40-70%
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hour light and 12 hour dark, music was palyed approximately 8 hours during the light period. - Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Backs of the animals
- % coverage: 10% of the total body surface
- Type of wrap if used: semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
24 hours after the application the dressing was removed and the skin was washed with lukewarm tap water and dried with disposable paper towels.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.0 ml. The test article was prepared in vehicle PEG 300 - Duration of exposure:
- 24 hours
- Doses:
- Rats were treated with FAT 41024/B at 2000 mg/kg by dermal application.
- No. of animals per sex per dose:
- 5 males and 5 females.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Four times during test day 1 and once daily during days 2-15
Body weight: On test day 1 (pre-administartion), 8 and 15.
Clinical signs: Each animal was examined for changing in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were reccorded.
- Necropsy of survivors performed: yes Necropsy were performed by experineced prosectors. At the end of teh observation period all animals were sacrified by intrperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320mg sodium pentobarbitone/kg body weight)
- Other examinations performed: clinical signs, body weight. - Statistics:
- No statistical analysis was used as no deaths occured.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: In all animals, residual test article was observed on the treated skin on test day two and persisted in two females until test day 14. No systemic signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic finding were observed at necropsy.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of FAT 41024/B after single dermal administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no deaths occured. LD50 is greater than 2000 mg/kg.
- Executive summary:
The purpose of this study was to assess the acute dermal toxicty of FAT 41024/B when administred to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days.
This experiment was performed according to the OECD Guideline 402 (Acute Dermal Toxicity).
A group of five male and five female HanIbm: WIST (SPF) rats was treated with FAT 41024/B at 2000 mg/kg by dermal application. The test article was prepared in vehicle (PEG 300) at a concentration of 0.5 mg/ml and administred at a volume of 4 ml/kg. The animals were examined for clinical signs four times during day 1 and once daily during days 2 -15.
Mortality /Viability were recorded together with clinical signs at the same time intervals.
Body weight were recorded on day 1 prior to administration and on days 8 and 15.
All animals were necropsied and examined macroscopically.
No deaths occured during the study.
In all animals, residual test article was observed on the treated skin on test day two and persisted in two females until test day 14. No systemic signs of toxicity were observed during the study period.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of FAT 41024/B after single dermal administartion to rats of both sexes, observed over a period of 14 days, could not be estimated as no deaths occured. LD50 is greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The acute oral toxicity study was performed in male and female rats and the test substance was applied at a dose level of 2000 mg/kg. No death occured during the study.The Oral LD50 was therefore considered to be greater than 2000 mg/kg.
An acute dermal toxicity was conducted with rats (5 males and 5 females) at a dose level of 2000 mg/kg. The substance was applied to the intact skin during 24 hours and no death occured during the study and following observation period. The acute dermal LD50 in rabbit is considered to be greater than 2000 mg/kg.
Justification for selection of acute toxicity – oral endpoint
Only this study in available
Justification for selection of acute toxicity – dermal endpoint
Only this study is available
Justification for classification or non-classification
Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).
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.