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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-530-3 | CAS number: 89899-25-2
- 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 LD50 for FAT 20290/A was found to be >5000 mg/kg bw.
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:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Diet: Rat food, NAFAG No. 890, NAFAG AG,Gossau, SG (Switzerland); ad libitum
- Water: ad libitum
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding
- Fasting: Prior to dosing, the animals were fasted overnight.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 55±15%
- Air changes: Approximately 15 air changes per hour
- Photoperiod: Light cycle of 12 hours light and 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Details on oral exposure:
- Volume (ml/kg body weight) applied: 20
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: body weight, clinical symptoms - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944) - Preliminary study:
- A preliminary study was not conducted.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Clinical signs such as dyspnoea, exophthalamos, ruffled fir, diarrhoea and curved body position were observed during the study.
- Gross pathology:
- No compound related gross organ changes were observed.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of FAT 20290/A after single oral administration to male/female rats, observed over a period of 14 days is >5000 mg/kg bw.
- Executive summary:
The acute oral toxicity potential of FAT 20290/A was evaluated in a study conducted according to OECD Guideline 401. Ten Tif:RAIf (SPF) rats that included 5 males and 5 females, were treated with FAT 20290/A by oral gavage administration at a dosage of 5000 mg/kg bw. The animals were examined daily during the observation period and mortality and clinical signs were recorded. Body weights were recorded on day 1 (prior to administration) and on days 7 and 14. All animals were necropsied at the end of the observation period. All animals survived until the end of the study period. Clinical signs such as dyspnea, exophthalmos, ruffled fir, diarrhea and curved body position were observed during the study. Dyspnea and exophthalmos were noted till Day 13, ruffled fur was noted till day 8. The body weight of the animals was within the range commonly recorded for this strain and age. No compound related gross organ changes were observed. Based on these findings, the median lethal dose of FAT 20290/A after single oral administration to rats observed over a period of 14 days is >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Good quality guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
In an acute oral toxicity study performed according to OECD guideline 401, ten Tif:RAIf (SPF) were treated with FAT 20290/A by oral gavage administration at a dosage of 5000 mg/kg bw. All animals survived until the end of the study period and no changes in the body weight and macroscopic findings were observed. Based on these observations, median lethal oral dose (LD50) to rats of FAT 20290/A was found to be >5000 mg/kg bw.
Inhalation:
Currently no study to assess the acute inhalation toxicity potential of Acid Blue 314 is available. However, the vapour pressure for the target chemical is considered to be low owing to the high melting point >350 °C, hence its considered to have low volatility. The median particle size of Acid Blue 314 was 49.468 µm, which indicates that the chemical may not be able to reach the alveolar region respiratory tract. Water solubility of the chemical was determined to be 302 g/L, meaning the dust particles of the chemical may be retained within the mucus. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. 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. Further the chemical was found to have low acute toxicity when tested via oral route with no mortality when tested at 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that Acid Blue 314 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.
Dermal:
Currently no study to assess acute dermal
toxicity of Acid Blue 314 is available. However, the molecular weight of
the chemical is 545.413 g/mol, indicating it being too large for dermal
absorption. Hence, the dermal uptake for the chemical is expected to be
low.The partition coefficient (n-octanol/water) of Acid Blue 314 was
determined to be -5.62, while the water solubility was 302 g/l.These
physicochemical properties indicate chemical istoo hydrophilic to cross
the lipid rich environment of the stratum corneum, supporting the
hypothesis that dermal uptake for the chemical will be low. The chemical
showed low toxicity potential in the available acute oral toxicity study
(LD50 >5000 mg/kg bw), with no mortality being seen. Similarly, absence
of systemic toxicity in skin irritation as well as sensitization
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. Hence,
low toxicity is expected on acute dermal exposure of Acid Blue 314 and
testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Based on the observed LD50 of >5000 mg/kg bw in acute oral study, Acid Blue 314 does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.