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Diss Factsheets
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EC number: 469-110-8 | CAS number: -
- 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:
- 7 November - 21 November 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): AD-1000
- Substance type: white powder
- Physical state: powder
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals were selected (10 weeks old).
- Weight at study initiation: Animals used within the study were of approx. the same age and body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: not applicable
- Housing: Before exposure: Group housing of 5 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm.) containing sterilised sawdust as bedding material and paper as cage-enrichment. After exposure: Group housing, maximally 5 animals per sex per cage in labelled stainless steel wire mesh cages. Two days after exposure the animals were housed as described above.
- Diet (e.g. ad libitum): Free access to pelleted rodent diet except during exposure to the test substance.
- Water (e.g. ad libitum): Free access to tap water except during exposure to the test substance.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 – 22.7
- Humidity (%): 37 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Nose-only
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: restraining tubes, which were connected to the exposure chamber. The design of the exposure chamber was based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983). The chamber consisted of 4 animal sections with 8 animal ports each. The number of open animal ports was adapted to the air flow in such a way that at each animal port the theoretical air flow was approximately 2.0 l/min, which ensures an adequate oxygen supply to the test animals. The inlet of the test atmosphere was located in the top section and the outlet was located in the bottom section. The direction of the flow of the test atmosphere guaranteed a freshly generated atmosphere for each individual animal. The placement of the individual animals in the inhalation chamber is shown in figure 2. All components of the exposure chamber which could come in contact with the test material were made of stainless steel, glass, rubber or plastic. To avoid exposure of the personnel and contamination of the laboratory the exposure chamber was placed in a fume hood, which maintained a slight negative pressure.
- System of generating particulates/aerosols: A dry powder aerosol was generated by administering the test substance to a stream of pressurized air (mean air flow 38 l/min) by means of a combination of a spiral feeder. The aerosol was led to a cyclone where larger particles were allowed to settle. Subsequently the aerosol was passed through the exposure chamber. From the exposure chamber the test atmosphere was passed through a set of filters before it was released to the exhaust of the fume hood.
- Method of particle size determination: The droplet size distribution was characterized twice during the exposure period. The samples were drawn (2 l/min) from the test atmosphere through a tube mounted in one of the free animal ports of one of the middle sections of the exposure chamber. The samples were collected with an 8 stage Marple personal cascade impactor, fiber glass filters and a fiber glass back-up filter. Amounts of test substance collected were determined gravimetrically. Subsequently the Mass Median Aerodynamic Diameter (MMAD) and the Geometric Standard Deviation were determined.
- Temperature, humidity, pressure in air chamber: 20.1-20.7oC; 30.5-37.5%;
TEST ATMOSPHERE
Nominal concentration: The nominal concentration was calculated by dividing the amount of test substance used by the volume of pressurized air (average air flow times exposure time) entering the exposure chamber used for exposure of the animals.
Actual concentration: The actual concentration was determined 7 times during the exposure period. Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of one of the middle sections of the exposure chamber. Samples were drawn through a glass fiber filter. The collected amount of test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter. Subsequently the mean concentrations and the standard deviations were calculated. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- The mean actual concentration was 5.2 ± 0.4 mg/l. The nominal concentration was 14.6 mg/l. The generation efficiency (ratio of actual and nominal concentration) was 35.6%.
- No. of animals per sex per dose:
- one group of five male and five female Wistar rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- No statistical analysis was performed (the method used was not intended to allow the calculation of a precise LC50 value).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Male: 5.2 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.2 mg/L; Number of animals: 5; Number of deaths: 1 - Clinical signs:
- other: During exposure: No clinical signs were noted. After exposure: Hunched posture, piloerection, ptosis and slow breathing were noted among the majority of animals. Laboured respiration was noted among the majority of the males and rales were noted in one f
- Body weight:
- The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- Effects on organs:
Granular, gray-white contents in the trachea, gray-white discolouration of the tongue and many, dark red
foci on the lungs were found at macroscopic post mortem examination of the animal that died during the study
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
Any other information on results incl. tables
The mean ' standard deviation of the temperature and
relative humidity during exposure were 20.6 ' 0.1°C and 34.8
' 2.5%.
The mean actual concentration was 5.2 ' 0.4 mg/l. The nominal concentration was 14.6 mg/l. The generation
efficiency (ratio of actual and nominal concentration) was 35.6%.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalatory LC50, 4h value of AD-1000 in Wistar rats was established to exceed 5 mg/l.
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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