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EC number: 247-269-2 | CAS number: 25797-81-3
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- (Duration of exposure was 1 h without any justification)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- FAT 20033/L TE
- IUPAC Name:
- FAT 20033/L TE
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 247-269-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 25797-81-3
- Molecular formula:
- C24H23N3O8S2.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- powder / dark blue
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E01A25-11 (DCT No. 70083)
Test material is dark blue powder
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Males and Females 275 to 344 g
- Housing: Housed individually, in suspended, wire bottom cages
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: Approx. 74±1 °F (ca. 23 °C)
- Humidity: 45-55 %
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 1.36 µm
- Details on inhalation exposure:
- - Generation of test atmosphere / chamber description: This test was conducted in a 40 L (36 x 36 x 31 cm) glass exposure chamber. The sides and the bottom of the chamber had centered holes (3-4 cm in diameter) to allow access to the chamber for testing and exhaust of the atmosphere. The port in the bottom of the chamber was centered over a 10 cm hole in a wooden platform. A funnel (8.5 cm in diameter) was brought from the underside of the platform through the hole and centered on the port in the bottom of the chamber. Dynamic air flow within the chamber was maintained by connecting the funnel to a vacuum pump for continuous changing of the chamber atmosphere.
A raised, tightly-fitting, wire mesh screen was placed over the bottom of the chamber and served as flooring for the test animals. This screen also served to raise the animals to a level such that the side ports in the chamber were at the breathing level of the animals. All measurements of particle size and concentration of the test substance were made from these side ports. Also, the delivery of the test substance into the chamber was done through one of the ports on the side of the chamber. The lid of the chamber also had a port which was used (if desired) for measuring the chamber atmosphere to insure even distribution of the test substance.
- Test substance generation: The test substance was generated as a dust using a 3-neck, round-bottom, 250 mL Pyrex flask. A stirring mechanism was placed through the center neck of the flask and an air line through one of the side necks. The third neck was connected by a glass elbow (which had an air vent to allow flushing) to the chamber. The dust was introduced into the chamber through a side port. A piece of rubber was taped over the outer area around the hole and a vertical slit made in the rubber to allow the entrance of the glass elbow from the dust generator. Constant flow of material was maintained by a calibrated flowmeter connected between the air line and the generating apparatus. In all instances, the air flow was maintained at or above 0.5 L of air/minute/rat.
- Exposure monitoring: Measurement of the atmospheric concentration of test substance in the chamber was achieved using a Gelman Model 1235 stainless steel filter holder containing a pre-weighed glass fiber filter (Gelman type AE-47 mm). The filter holder was attached to a vacuum pump which was regulated to exhaust 1 L of air/min from the chamber through the filter. Subsequent weighing of the filter after a designated period permitted the calculation of the atmospheric concentration of the test substance in the chamber during the exposure. Particle size determinations were made using a Cascade Impactor. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 1 h
- Concentrations:
- Mean achieved: 0.29±0.12 mg/L
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations:
Mortality and clinical signs- Four times during the exposure (15, 30, 45 and 60 minutes), twice after the exposure (3 and 6 h) on same day and daily once thereafter.
Body weights- pre-test, Day 1, 7 and 14
- Necropsy of survivors performed: Yes - Statistics:
- no data
Results and discussion
- Preliminary study:
- none
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.29 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No adverse effects were noted during the 1 h exposure or during the 14 d post-exposure period.
- Body weight:
- All animals displayed a normal pattern of weight gain.
- Gross pathology:
- All organs examined were normal.
- Other findings:
- none
Any other information on results incl. tables
Table: Method of calculating analytical concentration
|
SAMPLE 1 |
SAMPLE 2 |
SAMPLE 3 |
SAMPLE 4 |
Post Weight (mg) |
1495.5 |
1500.3 |
1500.3 |
1495.8 |
Pre-Weight (mg) |
1493.5 |
1495.9 |
1495.9 |
1493.3 |
Weight Difference (mg) |
2.0 |
4.4 |
4.4 |
2.5 |
Flow Rate (L/min) |
1 |
1 |
1 |
1 |
Sample Time (min) |
10 |
10 |
10 |
10 |
Air Volume (L) |
10 |
10 |
10 |
10 |
Analytical Concentration (mg/L) |
0.20 |
0.44 |
0.44 |
0.25 |
The average mass median particle diameter was 1.36 ± 0.26 µ. The 1 h LC50 value is >290 mg/mm³ (>0.29 mg/L).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 1 h inhalation LC50 value of the FAT 20033/D was considered to be >290 mg/mm³ (>0.29 mg/L).
- Executive summary:
A study was conducted to evaluate the acute inhalation toxicity of FAT 20033/D (ca. 46 % purity) following a method comparable to EPA OPPTS 870.1300 with deviations. A single group of 10 rats (5/sex) were exposed (whole body) for 1 h to the dust of the test substance at a mean achieved concentration of 0.29 mg/L (i.e. 290 mg/m³). A 14 d observation period followed. No mortality, change in body weight, clinical signs or gross pathological organ changes were observed during the study period. Hence, the 1 h inhalation LC50 value of the test substance was considered to be >290 mg/mm³ (>0.29 mg/L).
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