Registration Dossier
Registration Dossier
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EC number: 287-007-4 | CAS number: 85408-46-4
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- EC Number:
- 287-007-4
- EC Name:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- Cas Number:
- 85408-46-4
- Molecular formula:
- C17H12N4O3 . C17H12N4O3 . Cr. C12H28N to C14H32N
- IUPAC Name:
- Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-Geigy, Basel, Switzerland
- Weight at study initiation: 195-200 g
- Housing: The males and females were segregated and kept in Macrolon cages, type 4, (9 animals to a cage).
- Diet: rat food - NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1
- Humidity (%): 55+/- 5
- Photoperiod (hrs dark / hrs light): 10/14
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the dust.
- Rate of air: 20 L/min.
- System of generating particulates/aerosols: The dust was generated by injecting the test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm.
- Method of particle size determination: The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 hour intervals throughout the dust exposure. The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 nm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution: ca. 42 % particles > 7 µm, ca. 45 % particles of 3-7 µm, ca. 10 % particles of 1-3 µm and ca. 3 % particles of <1 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 9465 ± 632 mg/m3
- No. of animals per sex per dose:
- 9
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 9 465 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 8 833 - < 10 097
- Exp. duration:
- 4 h
- Mortality:
- no mortality occured
- Clinical signs:
- other: no clinical signs were found
- Body weight:
- no abnormal changes were detected
- Gross pathology:
- no gross pathology findings were detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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