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Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate
EC number: 942-981-6 | 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

Endpoint summary
Administrative data
Description of key information
Oral:
A study was performed to determine the acute oral toxicity of FAT 20077/A, by treating male and femaleSprague-Dawleyrats at 5000mg/kg bw and observed over a period of 14 days. A 25 % w/v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20 ml/kg (equivalent to 5000 mg/kg compound).
No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.Hence, based on these findings, the acute oral LD50 of FAT 20077/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.
Inhalation:
Currently no study to assess the acute inhalation toxicity potential of FAT 20077 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. 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 humansviathe inhalation route will be unlikely to occur. Further the chemical was found to have low acute toxicity when testedviaoral route with no mortality and clinical signs when tested at 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that FAT 20077 has a low toxicity potentialviainhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.
Dermal:
Currently no study to assess acute dermal toxicity of FAT 20077 is available. However, the molecular weight of the chemical is 710.17 g/mol, indicating it being too large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be low. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50>5000 mg/kg bw), with neither mortality nor clinical sings being seen. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expectedviathe 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 FAT 20077 and testing by the dermal route was considered scientifically not necessary.
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:
- 1975
- 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:
- None
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 192 g (males), 143 g (females)
- Fasting period before study: 18 h
- Housing: Rats were caged singly
- Diet: Commercial pelleted diet (ad libitum)
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 21±2 °C.
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Route of administration:
- oral: gavage
- Vehicle:
- other: deionised water
- Details on oral exposure:
- A 25 % w/v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted overnight, at a dose rate of 20 ml/kg (equivalent to 5 g/kg compound).
Ten rats (5 males and 5 females) were used for the study. - Doses:
- 5000 mg/kg/d
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 d
- At the end of the observation period, surviving animals were killed by exsanguinations under other anaesthesia and an autopsy performed.
- Other examinations performed: Mortality, clinical symptoms - Statistics:
- Not available
- Preliminary study:
- Not available
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- other: No clinical signs were observed during the study period.
- Gross pathology:
- No changes in organs or tissues were observed at autopsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of FAT 20077/A in rats is greater than 5000 mg/kg bw.
- Executive summary:
A study was performed to determine the acute oral toxicity of FAT 20077/A, by treating male and female Sprague-Dawley rats at 5000 mg/kg bw and observed over a period of 14 days. A 25 % w/v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20 ml/kg (equivalent to 5000 mg/kg compound). No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.Hence, based on these findings, the acute oral LD50 of FAT 20077/A in rats of both sexes observed over a period of 14 days is greater than 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 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:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No toxicity was seen in the acute oral toxicity study with FAT 20077/A, hence the substance does not warrant classification for acute toxicity as per the criteria of 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.
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