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EC number: 280-472-4 | CAS number: 83524-75-8
- 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:
- 13 Oct 1982 - 27 Oct 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- EC Number:
- 280-472-4
- EC Name:
- 2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- Cas Number:
- 83524-75-8
- Molecular formula:
- C40H26N2O6
- IUPAC Name:
- 7,18-bis[(4-methoxyphenyl)methyl]-7,18-diazaheptacyclo[14.6.2.2²,⁵.0³,¹².0⁴,⁹.0¹³,²³.0²⁰,²⁴]hexacosa-1(23),2,4,9,11,13,15,20(24),21,25-decaene-6,8,17,19-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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: THOM; Zuchtbetrieb: Dr. K. Thomae GmbH, 7950 Biberach
- Age at study initiation: 8 weeks
- Weight at study initiation: 245 g (males) and 179 g (females)
- Housing: type DIII (Fa. Becker)
- Diet: SSNIFF R 10 mm Pellet, Ssniff-Versuchstierdiäten GmbH, 4770 Soest, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- 1.9 µm
- Geometric standard deviation (GSD):
- 3.9
- 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 dust generator.
- 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 - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric determination
- Duration of exposure:
- 4 h
- Concentrations:
- 5.4 mg/L
- 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: daily
- Body weights: at the beginning of the study, after 7 days and at the end of the study
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.4 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: Erratic breathing, slight nasal excretion, ruffled fur during the first 4 days of the observation period, no abnormal findings were observed from day 5 onward.
- Body weight:
- Normal weight gain.
Day 7, mean weight (g): males: 267; females 201
Day 14, mean weight (g): males: 316; females 211. - Gross pathology:
- No abnormal findings.
Any other information on results incl. tables
Results of analytical measurements:
Sample No | Analyt. Conc. (mg/l) |
1 | 5.31 |
2 | 5.07 |
3 | 5.40 |
4 | 5.65 |
Mean | 5.4 |
standard deviation of the mean | 0.33 |
Nominal concentration | 39 |
Particle size analysis:
Stage | EACD 50% [µm] | [mg] | percentage distribution [%] | cummulative distribution [%] |
pre-impactor | 26.6 | 9.35 | 2.502 | 97.498 |
0 | 29.5 | 0.618 | 2.032 | 95.466 |
1 | 18.2 | 0.502 | 6.133 | 89.333 |
3 | 8.5 | 1.515 | 13.209 | 76.124 |
4 | 5.5 | 3.263 | 18.22 | 57.904 |
5 | 2.8 | 4.501 | 18.755 | 39 |
7 | 1.2 | 4.633 | 39.149 | 149 |
backup filter | < 1.2 | 9.671 | ||
Sum | 34.053 |
The MMAD 50% = 1.9 µm (geometrical standard deviation =3.9) was calculated from the results of the particle size analysis.
A respirable dust aerosol fraction that might reach the alveolar region of 89% was obtained from the results of the particle size analysis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EU and GHS classification criteria, no classification is warranted as to acute inhalation toxicity for the test substance.
- Executive summary:
In an acute inhalation toxicity study, 10 male and 10 female Wistar rats were exposed to the test substance as a dust aerosol at a concentration of 5.4 mg/L for 4 hours. The animals were observed for 14 days after exposure.
No mortality occurred at the tested concentration. Clinical signs observed after treatment were erratic breathing, slight nasal excretion, ruffled fur during the first 4 days of the observation period, no abnormal findings were observed from day 5 onward. The body weight gain of the test group was normal and compareable with the control group. No gross pathological abnormalities were noted during the necropsy at termination of the post exposure observation period.
Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) of 1.9 µm.
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