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EC number: - | 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
The acute oral LD50 of FAT 20042 in rats of both sexes observed over a period of 14 days is >2000 mg/kg bw, whereas the acute inhalation LC50 for FAT 20042 is >1353 mg/m³ air.
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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline followed
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Test article: FAT 20042/D
- Additional specification: Neolan Rosa BE ZP feucht
- Batch No.: 276
- Purity/Contents: ca. 50 %
- Physical properties: solid; black-red humid lumps
- Storage conditions: room temperature
- Validity: October, 1998
- Safety precautions: gloves and face masks
- Test material received: November 19, 1993 - Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation: 175 to 204 g
- Housing: Macrolon cages type 4
- Diet: ad libitum ((NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum
- Acclimation period: at least 5 days
- Fasting- overnight before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- None
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study.
- Clinical signs:
- other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 to 4 days.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found in all animals.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of compound FAT 20042/D in rats is >2000 mg/kg bw.
- Executive summary:
FAT 20042/D was investigated for acute oral toxicity in a study conducted according to OECD Guideline 401. In this study, group of rats (5 males and 5 females) were administered the test substance at 2000 mg/kg bw and observations for mortality, clinical signs, body weights were done for 14 days post administration. No mortalities occurred in this study. Piloerection , hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 to 4 days. Body weight and body weight gain were not affected. At necropsy, no deviations from normal morphology were found in all animals. Based on the findings, the acute oral median lethal dose (LD50) of compound FAT 20042/D in rats was found to be >2000 mg/kg bw in both sexes.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Principles of method if other than guideline:
- Nose only exposure of rats to aerosols generated by injecting two different amounts of the solid test material with the help of a Grafix Exaktomat Injector (Cerutti AG, Bern, Switzerland) into an air stream which was discharged into the exposure chamber at a rate of 20 l/min. Exposed animals were then observed for mortality, clinical signs and body weight changes over 14 days observation period. Using the Probit method on the mortality observed, LC50 for the substance was estimated.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif : RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In house bred
- Housing: Separately, in Macrolon cages, type 4
- Diet: rat food (NAFAG, Gossau SG), ad libitum
- Water: ad libitum
- Acclimatization: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Mass median aerodynamic diameter (MMAD):
- > 7 µm
- Remark on MMAD/GSD:
- Particle size distribution analysis of the chamber airborne particles showed that approximately 40 % were smaller than 7 µm in diameter.
- Details on inhalation exposure:
- For inhalation the rats were kept in separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the aerosol. During the exposure period the following parameters were controlled once at half time of the study inside the inhalation cylinder: temperature (with a Therm 2104 contact thermometer, Ahlborn Messund Regeltechnik, 815 Holzkirchen, Germany), relative humidity (with a VASALA Humidity Indicator HMI 11, Kelag AG, 8057 Zurich, Switzerland) and oxygen content (with a DRAEGER E 15 stationary control system, Draegerwerk AG, Lübeck, Germany).
After a 4 hour inhalation the rats were returned to their cages. Physical condition and incidence of death were monitored throughout an observation period of 14 days.
Preparation of aerosol
The aerosol was generated by injecting two different amounts of the solid test material with the help of a Grafix Exaktomat Injector (Cerutti AG, Bern, Switzerland) into an air stream which was discharged into the exposure chamber at a rate of 20 L/min. The control animals were exposed to filtered air under the same conditions as the animals exposed to the test substance.
The concentration and the particle size distribution of the aerosol in the vicinity of the animals were monitored at regular intervals throughout the aerosol exposure. The concentration was determined 5 times gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the particles was measured twice with a 4 stage Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 0, 877 and 1353 mg/m3
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (mortality and clinical signs): daily
- Frequency of observations (body weight): Day 1 (before exposure), 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- None
- Preliminary study:
- No data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 300 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality observed.
- Clinical signs:
- other: Dyspnoea, exophthalmos, ruffled fur and curved body position were observed at both doses. The animals exposed to the test material recovered within 4 days. The control rats failed to show any symptoms during the exposure and observation period.
- Body weight:
- No significant change was seen with body weight and body weight gains of the exposed animals.
- Gross pathology:
- Partially congested organs were observed.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 for FAT 20042/B was estimated to be >1353 mg/m3.
- Executive summary:
The acute inhalation toxicity of FAT 20042/B was investigated in a study conducted according to the method of Sachsse et al. (1973, 1976). In this study, groups of young adult rats (each consisting of 10 males and 10 females) were exposed to test concentrations of 0, 877 and 1353 mg/m3. 4 hour inhalation exposure was given to the rats through tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only got exposed. Mortality, clinical signs and body weight changes were monitored throughout an observation period of 14 days and the surviving animals were subjected to the gross necropsy after the completion of observation period. Particle size distribution analysis of the chamber airborne particles showed that approximately 40 % were smaller than 7 µm in diameter. No mortality observed throughout the study. Dyspnoea, exophthalmos, ruffled fur and curved body position were observed at both doses. The animals exposed to the test material recovered within 4 days. The control rats failed to show any symptoms during the exposure and observation period. No significant change was seen with body weight and body weight gains of the exposed animals. Partially congested organs were observed at gross necropsy. based on the findings of the study, the LC50 for FAT 20042/B was estimated to be >1353 mg/m3.
Reference
Environmental conditions recorded in the exposure chamber:
- Temperature: 23 - 24 °C
- Relative humidity: 48 - 58 %
- Oxygen content volume : 20 %
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 300 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
Acid Red 195 had been evaluated in three different acute oral toxicity studies. Outcome from all three studies indicate that Acid Red 195 on acute oral exposure has low toxicity potential.
In a key study (1994), FAT 20042/D was investigated for acute oral toxicity according to OECD Guideline 401. In this study, group of rats (5 males and 5 females) were administered the test substance at 2000 mg/kg bw and observations for mortality, clinical signs, body weights were done for 14 days post administration. No mortalities occurred in this study. Piloerection , hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 3 to 4 days. Body weight and body weight gain were not affected. At necropsy, no deviations from normal morphology were found in all animals. Based on the findings, the acute oral median lethal dose (LD50) of compound FAT 20042/D in rats was found to be >2000 mg/kg bw in both sexes.
In a supporting study (1978) conducted to evaluate the acute oral toxicity potential, FAT 20042/B was administered to groups of rats (each consisting of 5 males and 5 females) by oral gavage, at doses of 5000, 6000 and 7000 mg/kg bw. The treated animals were observed for mortality, clinical signs and body weight changes over 14 days post administration of the test substance and subjected to gross necropsy after the completion of observation period. No mortality was observed at any of the administered doses. Dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position being the common clinical signs in acute tests were observed. The animals recovered within 9 to 12 days. Body weight and body weight gains were not affected. No substance related gross organ changes were seen. Hence based on the above findings of the study, the LD50 of FAT 20042/B in rats of both sexes, observed over a period of 15 days, was estimated to be > 7000 mg/kg bw.
In a study (1974) investigating acute oral toxicity potential, FAT 20042/A was administered to groups of rats (each consisting of 5 males and 5 females) by oral gavage, at doses of 3170, 4640, 6000 and 7750 mg/kg. The treated animals were observed for mortality and clinical signs over 14 days post administration of the test substance and subjected to gross necropsy after the completion of observation period. No mortality was observed. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 6 to 8 days. No substance related gross organ changes were seen. Based on the findings of the study, LD50 of FAT 20042/A in rats of both sexes, observed over a period of 15 days, was estimated to be 5514 mg/kg bw.
Inhalation:
The acute inhalation toxicity of FAT 20042/B was investigated in a study conducted according to the method of Sachsse et al. (1973, 1976). In this study, groups of young adult rats (each consisting of 10 males and 10 females) were exposed to test concentrations of 0, 877 and 1353 mg/m3. 4 hour inhalation exposure was given to the rats through tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only got exposed. Mortality, clinical signs and body weight changes were monitored throughout an observation period of 14 days and the surviving animals were subjected to the gross necropsy after the completion of observation period. Particle size distribution analysis of the chamber airborne particles showed that approximately 40 % were smaller than 7 µm in diameter. No mortality observed throughout the study. Dyspnoea, exophthalmos, ruffled fur and curved body position were observed at both doses. The animals exposed to the test material recovered within 4 days. The control rats failed to show any symptoms during the exposure and observation period. No significant change was seen with body weight and body weight gains of the exposed animals. Partially congested organs were observed at gross necropsy. based on the findings of the study, the LC50 for FAT 20042/B was estimated to be >1353 mg/m3.
Dermal:
Currently no study to assess acute dermal toxicity of Acid Red 195 is available. However, the molecular weight of the substance is 513.4-553.4 g/mol, which indicates substance is too large for dermal absorption. Further, high water solubility (250.8 g/L) and low partition coefficient (-3.30 at 20 °C), indicate the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance is expected to be low. Further, neither mortality nor systemic effects were observed in the acute oral toxicity studies with Acid Red 195. Owing to the high water solubility, absorption through gastro-intestinal tract through oral ingestion is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, acute dermal exposure is considered to have negligible potential for systemic toxicity. Additionally, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected via the dermal route.Therefore testing by the inhalation route was considered scientifically not necessary and the intrinsic property/toxicity potential can be extrapolated from the data available from acute oral toxicity study.
Justification for classification or non-classification
Based on the available data from acute toxicity studies with FAT 20042, thetest substance does not meet the criteria for classification for acute toxicity according to the CLP (1272/2008) Regulation.
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