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EC number: 225-590-9 | CAS number: 4948-15-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- EC Number:
- 225-590-9
- EC Name:
- 2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- Cas Number:
- 4948-15-6
- Molecular formula:
- C40H26N2O4
- IUPAC Name:
- 2,9-bis(3,5-dimethylphenyl)isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Lot/Batch No.: 19695
- Analytical purity: ca. 98%
- Physical state: solid
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: strain: SPF Wistar/Chbb: THOM; breeding facility: Dr. K. Thomae GmbH, D-7950 Biberach, FRG)
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 251 g (males) and 172 g (females)
- Housing: cages type D III of Becker, without bedding, 5 animals per cage
- Diet (e.g. ad libitum): KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: Aerosil
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 20 (glass-steel construction, BASF Aktiengesellschaft)
- Exposure chamber volume: ca. 55 L
- Method of holding animals in test chamber: the animals were restrained in tubes and their snouts projected into the inhalation chamber
- Source and rate of air: 1500 L/h, supply air
- Method of conditioning air: The exposure system was placed in an air-conditioned laboratory. Temperatures in the exposure system were 19-25 °C
- System of generating particulates/aerosols: A dust aerosol air mixture was generated by means of a dosing-wheel dust generator (Gericke/BASF).
- Method of particle size determination: Stack Sampler Mark III (Andersen)
TEST ATMOSPHERE
- Brief description of analytical method used: The preweighed filter was placed into the filtration equipment. By means of a vacuum compressed air pump a volume of the dust aerosol was drawn through the filter. The dust concentration in mg/l was calculated from the difference between the preweight of the filter and the weight of the filter after sampling, with reference to the sample volume of the inhalation atmosphere. The concentration was corrected for the amount of the added excipient.
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable): 1 wt% of Aerosil
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 3.0 µm (GSD: 3.6) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric determination
- Duration of exposure:
- 4 h
- Concentrations:
- 5.2 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were recorded several times during exposure and at least once an each workday in the observation period. A check for dead animals was made daily.
- Necropsy of survivors performed: yes - Statistics:
- The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp. 32 - 35).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.2 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None of the animals died during the observation period
- Clinical signs:
- other: Irregular, accelerated and/or intermittent respiration, flight behaviour and discoloured fur. From day 7 of the observation period onward, no abnormalities, except discoloured fur, were detected in the animals.
- Body weight:
- The body weight gain of male and female rats in the test group, compared with a historical control collective, was not affected by the substance over the total observation period.
- Gross pathology:
- No pathologic findings were noted.
Any other information on results incl. tables
Results of analytical measurements:
Sample No | Analyt. Conc. (mg/l) |
1 | 5.01 |
2 | 5.5 |
3 | 5 |
4 | 5.32 |
Mean | 5.26 |
mean corrected for 1 % additive | 5.22 |
mean rounded | 5.2 |
standard deviation of the mean | 0.2 |
Nominal concentration | 16.8 |
Particle size analysis:
Cascade Impactor | ||||
Stage | EACD 50% [µm] | [mg] | percentage distribution [%] | cummulative distribution [%] |
pre-impactor | 26.6 | 0.97 | 4 | 96 |
0 | 29.5 | 0.79 | 3.3 | 92.7 |
1 | 18.2 | 2.67 | 11.1 | 81.6 |
3 | 8.5 | 2.69 | 11.2 | 70.5 |
4 | 5.5 | 6.58 | 27.2 | 43.3 |
5 | 2.8 | 4.45 | 18.4 | 24.9 |
7 | 1.2 | 6.01 | 24.9 | - |
backup filter | < 1.2 | |||
Sum | 24.15 |
The MMAD 50% = 3.0 µm (geometrical standard deviation =3.6) was calculated from the results of the particle size analysis.
A respirable dust aerosol fraction that might reach the alveolar region of 82% was obtained from the results of the particle size analysis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 was concluded to be greater than 5.2 mg/L.
- Executive summary:
In an inhalation toxicity study according to OECD guideline 403, Wistar rats (5/sex) were exposed to the test article as dust for 4 hours at a measured concentration of 5.2 mg/L followed by a 14-day observation period. Cascade impactor measurements resulted in a particle size distribution with a mass median aerodynamic diameter (MMAD) of 3 µm (GSD: 3.6), which is well within the respirable range. None of the animals died during the study period. Clinical signs included irregular, accelerated and/or intermittent respiration, flight behaviour and discoloured fur. From day 7 of the observation period onward, no abnormalities, except discoloured fur, were detected in the animals. The body weight gain of male and female rats in the test group, compared with a historical control collective, was not affected by the substance over the total observation period. No pathologic findings were noted during gross pathology. The LC50 determined on the basis of the study results was >5.2 mg/L.
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