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EC number: 274-436-7 | CAS number: 70210-39-8
- 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 Reactive Red 66 in rats of both sexes is greater than 7750 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:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The acute oral LD50 of FAT 40063/A in rats of both sexes observed over a period of 14 days.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inhouse (bred under SPF conditions in our own breeding unit)
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: Overnight
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet: (NAFAG, Gossau SG, rat food) ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approx. 50 % - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- FAT 40063/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was" kept stable with a magnetic stirrer.
- Doses:
- 4640, 6000, 7750 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
- Frequency of observations and weighing: Observed at 1, 24, 48 h, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weight, Gross pathology - Statistics:
- None
- Preliminary study:
- None
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 750 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was found at any dose level
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. However, all animals had recovered within 8 days
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of FAT 40063/A in rats is greater than 7750 mg/kg bw
- Executive summary:
FAT 40063/A was tested on 30 Tif. RAI rats (15 males and 15 females), at the dose level of 4640, 6000 and 7750 mg/kg bw. FAT 40063/A was weighed into an Erlenmeyer flask on a Mettler balance and suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment, the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. The rats were starved during one night before starting the treatment. Within 2 hours after treatment, the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 8 days. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Based on the study results, the acute oral median lethal dose (LD50) of FAT 40063/A in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg based on test material.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 7 750 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- 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
Acute oral toxicity:
FAT 40063/A was tested on 30 Tif. RAI rats (15 males and 15 females), at the dose level of 4640, 6000 and 7750 mg/kg bw. FAT 40063/A was weighed into an Erlenmeyer flask on a Mettler balance and suspended at 30 % with polyethylene glycol (PEG 400) and administered by oral intubation. Before treatment, the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. The rats were starved during one night before starting the treatment. Within 2 hours after treatment, the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 8 days. They were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Based on the study results, the acute oral median lethal dose (LD50) of FAT 40063/A in rats of both sexes observed over a period of 14 days is greater than 7750 mg/kg based on test material.
Acute inhalation toxicity:
Currently, no study to assess the acute inhalation toxicity potential of Reactive Red 066 is available. However, the substance is considered to have low volatility (owing to vapour pressure: 0.00607 Pa and the high melting point: >350 °C). Synthesis and formulation of this chemical is performed in a closed process; the final product consists of liquid formulations only. 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. 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, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as liquid formulation, the exposure via inhalation is considered to be unlikely. Further, in case the substance is entering the respiratory tract, owing to its high-water solubility, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50 >7750 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Reactive Red 066 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.
Acute dermal toxicity:
Currently, no study to assess the acute dermal toxicity potential of Reactive Red 066 is available. However, the molecular weight of the chemical is 629.4 g/mol, indicating it being too large for dermal absorption. It has n-octanol/water partition coefficient (log P) of -2.49, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance will be low. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50 >7750 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Similarly, absence of local toxicity in skin irritation as well as sensitization studies, further supports the conclusion that low toxicity is 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 above arguments into account, low toxicity potential is expected on acute dermal exposure of Reactive Red 066 and hence testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Based on the observed LD50 of >7750 mg/kg bw in the acute oral toxicity study, the Reactive Red 066 does not considered to be classified according to according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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