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EC number: 229-175-3 | CAS number: 6422-83-9
- 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:
- 1989-11-23 to 1989-12-27
- 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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione
- EC Number:
- 229-175-3
- EC Name:
- 1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione
- Cas Number:
- 6422-83-9
- Molecular formula:
- C15H10N2O4
- IUPAC Name:
- 1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 267 ± 19.1 g; females: 190 ± 8.2 g
- Housing: groups of five animals in cages type D III of Becker, without beedding
- Diet (e.g. ad libitum): ad libitum during the post exposure period, Kliba rat/mouse laboratory diet 24-343-4 10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst Switzerland
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- > 1.8 - <= 3.1 µm
- Geometric standard deviation (GSD):
- >= 3 - <= 3.7
- Remark on MMAD/GSD:
- The MMAD and the GSD was calculated from the results of the particle size analysis which was performed for each test group.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER
DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 20 (glass-steel construction. BASF Aktiengesellschaft, volume V =55 L): the animals were restrained in tubes and their snouts projected into the inhalation chamber.
- Exposure chamber volume: 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: compressed air and dilution were set to: 1,500 [1/h]
- Method of conditioning air: The dilution air was conditioned via a central air-conditioning system
- System of generating particulates/aerosols: A dust aerosol was generated by means of an solid, particle generator [brush generator, Technical University of Karlsruhe/BASF] (test group 1) and a dosing-wheel dust generator (Gericke/BASF) (test groups 2, 3, 4).
- Method of particle size determination: At the beginning of the test in test group 1 or 30 min earliest after beginning of the test in test groups 2-4 one sample was taken for the particle size analysis. Before the sampling, the impactor was equipped with glass-fiber collecting discs and a backup particle filter. The impactor was connected to the pump and the test apparatus, and one sample (9-720L) was taken. The impactor was taken apart, and the collecting discs and the backup particle filter were weighed. The contents of the pre-impactor as well as the amounts of the material adsorbed on the walls of the impactor and in the sampling probe (wall losses) were also determined quantitatively.
- Treatment of exhaust air: By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10% lower (excess pressure). This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.
- Temperature: 19-25 °C
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric determination of the inhalation atmosphere concentration: The preweighed filter was placed into the filtration equipment, By means of a vacuum compressed air pump 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 concentrations were corrected for the amount of the additive.
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable):The test substance was mixed with 1%[w/w] Aerosil
- Justification of choice of vehicle: The vehicle was chosen in order to achieve a more uniform dust concentration in air. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric determination of the inhalation atmosphere concentration
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 0.016, 0.13, 0.52, 5.0 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days for the test groups 2-4 and 16 days for the test group 1.
- Frequency of observations and weighing: Body weight was determined before 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 on each workday in the observation period. Mortality was checked daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Statistics:
- The statistical evaluation of the dose-response relationship was carried out using FORTRAN program AKPROZ. Depending on the data of the dose-relationship obtained by way of experiment, this program is used to estimate the LC50 or to perform a Probit analysis. Estimation of the LC50 will produce types LC50 greater, LC50 about, or LC50 smaller. If the reults are Type LC50 greater or LC50 smaller, an additional binominal test will be carried out, to verify these statements statistically, if necessary. The calculation of the particle size distribution was carried out on the basis of mathematical methods for evaluating particle measurements (DIN 66141: Darstellung von Korngrößenverteilungen, DIN 66161: Partikelgrößenanalyse)
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 0.09 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 0.016 - < 0.13 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: The statistical reliability for the male rats is 95 %.
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- ca. 0.13 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Test group 1: No deaths occurred until the end of the observation period.
Test group 2: 5 males and 2 females died on the day of exposure.
Test group 3: 3 males and 4 females died on the day of exposure and 2 males and 1 female died on observation day 1.
Test group 4: 5 males and 5 females died on the day of exposure. - Clinical signs:
- other: Test group 1: All animals showed accelerated respiration during the exposure time. From day 1 after exposure until the end of the 16 days observation period no further clinical signs were reported. Test group 2: During the exposure time and the first 2 ob
- Body weight:
- The body weight gain of males and females of test group 1 was retarded, for males in observation week 1 and for females in observation week 2. However, the male animals in test group 1 regained body weight during the second week and was adjusted to normal. Body weight gain in test group 2 could only be detected in female rats and was not affected by the treatment as compared to a historical control collective. The body weights of test groups 3 and 4 were not recorded during the observation period due to premature death of the animals.
- Gross pathology:
- At the end of the obsevation period (14 days test groups 2, 3, 4; 16 days test group 1) the surviving animals were sacrificed with CO2 and were subjected to gross-pathological examination like all other animals which had died before.
Findings in animals that died spontaneously: Lungs: marked hyperemia with edema and/ or with emphysema; Thorax: hydrothorax in some animals. Findings in the sacrificed animals: None.
Any other information on results incl. tables
Table 1: concentration measurements
Sample No |
Analytical concentration [mg/L] |
Test group 1 |
|
13 |
0.018 |
14 |
0.017 |
15 |
0.016 |
16 |
0.014 |
Mean |
0.0163 |
Mean corrected for 1% additive |
0.0161 |
Mean (rounded) |
0.016 |
Standard deviation of the mean |
±0.0017 |
Nominal concentration |
0.021 |
Test group 2 |
|
9 |
0.17 |
10 |
0.13 |
11 |
0.13 |
12 |
0.12 |
Mean |
0.138 |
Mean corrected for 1% additive |
0.134 |
Mean (rounded) |
0.13 |
Standard deviation of the mean |
±0.022 |
Nominal concentration |
5.77 |
Test group 3 |
|
5 |
0.54 |
6 |
0.53 |
7 |
0.56 |
8 |
0.48 |
Mean |
0.528 |
Mean corrected for 1% additive |
0.518 |
Mean (rounded) |
0.52 |
Standard deviation of the mean |
±0.034 |
Nominal concentration |
15.5 |
Test group 4 |
|
1 |
5.25 |
2 |
5.35 |
3 |
5.11 |
4 |
4.68 |
Mean |
5.10 |
Mean corrected for 1% additive |
5.049 |
Mean (rounded) |
5.0 |
Standard deviation of the mean |
±0.30 |
Nominal concentration |
28.1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- In the present study conducted according to OECD guideline 403, GLP, 5 female and 5 male Wistar rats were exposed to 0.016, 0.13, 0.52, 5.0 mg/L of the test substance using a head-nose inhalation system for 4h. The animals were observed for further 14 days in test group 2-4 and for 16 days in test group 1. In test group 2, 3 and 4, three female, two male and 1 female and five male and five female animals died after exposure, respectively. In test group 3 all animals were dead at the end of observation day 1. The combined LC50 for male and female rats was estimated to be 0.09 mg/L air. Based on the study results, the test material fulfils the criteria for classification as acute toxicity by inhalation Category 2 in accordance with Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be fatal if inhaled.
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