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EC number: 944-283-7 | 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 ACID YELLOW 104 in rats of both sexes observed over a period of 14 days was found to be 6213 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:
- supporting study
- Study period:
- 1980
- 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
- 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
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Sex: male/female
- Housing: housed in groups of 5 in Macrolon cages (type 3),
- Diet: rat food (NAFAG, Gossau SG) ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 55±10 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day.
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- None
- Doses:
- 2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw
10 and 20 ml/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- None- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 1, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 including 95 % confidence limits were calculated by the logit model.
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw
- Clinical signs:
- Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days.
- Body weight:
- No adverse effects on body weight changes were seen.
- 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 compound FAT 20041/B in rats is >9000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 20041/B was evaluated using a methodology that was similar to OECD Guideline 401. After administration of the compound at 2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw, the groups (5 male and 5 females in each group) of rats were observed for 14 days. Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days. No adverse effects on body weight changes were seen. At autopsy no changes caused by the administration of FAT 20041/B were seen. In conclusion, the acute oral LD50 of FAT 20041/B in rats of both sexes observed over a period of 14 days is concluded to be >9000 mg/kg bw.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 213 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
ACID YELLOW 104 was evaluated in two studies conducted according to the methodology that was similar to the one described in OECD Guideline 401.
In the study designated as key, groups of rats (5 males and 5 females in each group) were administered FAT 20041/A at 2150, 3590, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 days. Following adminstration of the test substance, mortalities recorded were as follows: 1 male at 3590 mg/kg bw, 2 females at 4640 mg/kg bw, 1 male and 1 female at 6000 mg/kg bw, 3 males and 5 females at 7750 mg/kg bw, 5 males and 5 females at 10000 mg/kg bw. 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 7 to 8 days. At autopsy no changes caused by the administration of FAT 20041/A were seen with found dead as well as surviving animals.In conclusion, the acute oral LD50 of FAT 20041/A in rats of both sexes observed over a period of 14 days is 6213 mg/kg bw.
In the second study, the groups (5 male and 5 females in each group) of rats were observed for 14 days following administration of FAT 20041/B at 2000, 3000, 4000, 5000, 7000 and 9000 mg/kg bw. Following mortality was observed: 2 females at 3000 mg/kg bw and 1 female each at 4000 and 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, curved body position were observed. The surviving animals recovered within 8 to 9 days. No adverse effects on body weight changes were seen. At autopsy no changes caused by the administration of FAT 20041/B were seen.In conclusion, the acute oral LD50 of FAT 20041/B in rats of both sexes observed over a period of 14 days is concluded to be >9000 mg/kg bw.
Acute inhalation toxicity:
Currently no study to assess acute inhalation toxicity potential of ACID YELLOW 104 is available.However, the substance is considered to have low volatility as the melting point is >350 °C. ACID YELLOW has high water solubility of 366 g/L, indicating if dust is produced/inhaled, will be trapped in the mucus and transferred to the GI tract by mucociliary clearance or coughed up.The median particle size of 47.77 µm indicates that the major part of the test substance will not be able to reachalveolar region of the respiratory tract.Further the substance was found to have low toxicity (LD50 = 6213 mg/kg bw) when tested in acute oral toxicity studies, thus indicating low toxicity on acute exposure. Taking into account the above arguments, ACID YELLOW 104 is considered to have low toxicity on acute inhalation exposure. Hence, the study is considered scientifically not necessary.
Acute dermal toxicity:
Currently no study to assess acute dermal toxicity potential of ACID YELLOW 104 is available. However, the molecular weight of the substance ranges from 491.35 – 531.35 g/mol, which indicates substance is partcularly large for dermal absorption. Further, high water solubility (399.9 g/L) and low partition coefficient (log Pow = -4.75), indicate the substance may be too hydrophilic to cross the lipid rich environment of thestratum corneum. Hence, the dermal uptake for the substance is expected to be low. The substance showed low toxicity potential in the available acute oral toxicity studies (LD50= 6213 mg/kg bw). Similarly absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected via dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the test item only show up upon dermal exposure and not after systemic application, hence further experiments to assess dermal toxicity are not taken into account.
Justification for classification or non-classification
Based on the available data from acute toxicity studies, ACID YELLOW 104 does not meet the criteria of classification for acute toxicity according to the CLP (1272/2008) Regulation.
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