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EC number: 274-660-5 | CAS number: 70528-90-4
- 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 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 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:
- key study
- Study period:
- Experiment start date: 06 December 1979; Experiment end date: 04 February 1980; Study completion date: 07 March 1980.
- 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)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Name: FAT 36091/D
Purity: 50.2 % - Species:
- rat
- Strain:
- other: Tif:RAIf (SPF) strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Healthy random bred rats of the Tif: RAIf (SPF) strain (7 to 8 weeks old) raised on the premises were used for these experiments. They were kept at a room temperature of 22 + 2 °C, at a relative humidity of 55 + 10 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2% (w/v) in dist. water.
- Details on oral exposure:
- VEHICLE
Volume (ml/kg body-weight): 20
The test item was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. - Doses:
- 5000, 7000, 8000 and 10000 mg/kg.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight.
Treatment and observations
Animals fasted overnight were treated by single oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period. - Statistics:
- LD50 inclusing 95 % confidence limits are calculated by the logit model.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 5000 mg/kg: No deaths observed.
At 7000 mg/kg: 1 male died
At 8000 mg/kg: 2 male and 3 female died
At 10000 mg/kg: 3 male and 2 female died - Clinical signs:
- other: - Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved were observed at 5000 mg/kg. The surviving animals recovered within 7 days. - Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved were observed at 7000 mg/kg. The surviving an
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg.
- Executive summary:
A study was conducted according to method similar or equivalent to OECD TG 401 to determine the acute oral toxicity of the test on rats via oral route. 5 males and 5 females were given following doses; 5000, 7000, 8000, 10000 mg/kg bw. Physical condition and rate of deaths were monitored throughout the whole observation period. Doses of 5000 to 10000 mg/kg bw was given by oral gavage. Before administration, the test item was prepared in CMC (Carboxymethyl cellulose).
Mortality;
At 5000 mg/kg: No deaths observed.
At 7000 mg/kg: 1 male died
At 8000 mg/kg: 2 male and 3 female died
At 10000 mg/kg: 3 male and 2 female died
Symptoms were observed in all dose levels: Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved. The surviving animals recovered within 7 to 8 days. The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg.
Reference
Body weight changes:
Dose (mg/kg) | |||||
5000 | 7000 | 8000 | |||
Day 1 Male | Mean body weight/SD (g) | 208/18.4 | 185/14.2 | 188/9.0 | 188/11.4 |
Day 1 female | Mean body weight/SD (g) | 180/8.3 | 180/5.9 | 174/7.3 | 173/4.6 |
Day 7 Male | Mean body weight/SD (g) | 243/23.4 | 239/16.7 | 220/10.0 | 247/11.3 |
Day 7 female | Mean body weight/SD (g) | 205/13.6 | 198/8.6 | 193/10.6 | 195/.0. |
Day 14 Male | Mean body weight/SD (g) | 290/25.5 | 280/21.9 | 261/12.9 | 293/20.5 |
Day 14 female | Mean body weight/SD (g) | 237/27.8 | 212/3.8 | 223/15.6 | 218/8.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 8 000 mg/kg bw
- Quality of whole database:
- The experiment was performed according to a guideline equivalent or similar to the OECD Guideline 401 (Acute Oral toxicty).
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 substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
A n in vivo study was performed to determine the acute oral toxicity of FAT 36091 (batch D) on rats equivalent or similar to the OECD Guideline 401 (Acute Oral toxicity). 5 males and 5 female Tif. RAI rats where exposed at each dose level (5000/7000/8000 and 10000 mg/kg bw) and observed for 14 consecutive days. Symptoms were observed in all dose levels: Sedation, dyspnoea, ruffled fur, diarrhoea, body position curved. The surviving animals recovered within 7 to 8 days. The LD50 was determined to ca. 8000 mg/kg bw in rats of both sexes. A second (supporting) study was carried out to determine of the acute oral toxicity of FAT 36091, (batch A), using Tif. RAI rats. Before administration by gavage, FAT 36091 was suspended in carboxymethyl cellulose (CMC).The test material was administered at different doses to 5 males and 5 females. Symptoms were observed in all dose levels. All surviving animals recovered within 10 days. The acute oral LD50 of FAT36091/A in rats of both sexes observed over a period of 14 days is found to be 6058 mg/kg (5248-6992).
Acute toxicity: inhalation
Currently no study is available to assess the acute inhalation
toxicity potential of Disperse yellow 211. The calculated value for
vapour pressure was found to be 1.1E-8 Pa at 25 °C. Hence the substance
is considered to have low volatility. Synthesis and spray drying of this
chemical is performed in closed processes; 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. 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 chemical is imported into
the EU in a formulated form as a dust-free powder or as a granulate, the
exposure via inhalation is considered to be unlikely. The chemical
showed low toxicity potential in the available acute oral toxicity
studies (LD50: >2000 mg/kg bw), with no systemic toxicity being seen,
hence it does not need to be classified STOT SE and low toxicity is
expected for this chemical via the inhalation route. Taking into
consideration the above arguments, low toxicity potential is expected on
acute exposure of Disperse yellow 211 via inhalation route and hence
testing by the inhalation route was considered scientifically not
necessary.
Acute toxicity: dermal
Currently no study to assess acute dermal
toxicity of Disperse Yellow 211 is available. However,
the molecular weight of the chemical is 361.7 g/mol, indicating limited
dermal absorption. The substance has
low solubility in water (3.9 mg/L), hence dermal uptake is likely to be
low as the substance is considered as not sufficiently soluble in water
to partition from the stratum corneum into the epidermis. Further, no
adverse effects were observed in acute oral studies (LD50 >2000 mg/kg)
suggesting that the substance has low toxicity, hence
it does not need to be classified as STOT SE.
Hence no significant toxicity is expected via dermal route and safety
for human health can be estimated via route to route extrapolation.
Similarly, absence of systemic toxicity or mortality in skin irritation
and sensitization studies, 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
The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg. The test item does not meet the criteria for classification according to the Globally Harmonized Classification System.
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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