Registration Dossier
Registration Dossier
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EC number: 203-696-6 | CAS number: 109-69-3
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1st- 31th, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
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:
- , 1981
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-chlorobutane
- EC Number:
- 203-696-6
- EC Name:
- 1-chlorobutane
- Cas Number:
- 109-69-3
- Molecular formula:
- C4H9Cl
- IUPAC Name:
- 1-chlorobutane
- Details on test material:
- - Name of test material (as cited in study report): n-Butylchlorid
- Storage condition of test material: in well-closed containers at a well-ventilated place; protected from inflammable matter
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht HAGEMANN GmbH & Co., Exertal 1, Germany
- Age at study initiation: 51 - 54 days
- Weight at study initiation: 229 - 249 g (males); 212 - 250 g (females)
- Fasting period before study: 16 hours
- Housing: in groups of two or three in MAKROLON cages (type III)
- Diet: ad libitum standardized diet for rats ALTROMIN 1324 (ALTROMIN GmbH, Lage/Lippe, Germany); analysed for contaminants
- Water: ad libitum tap water; analysed regularly
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Feb. 1990 To: March 15th, 1990
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation apparatus with a nose-only exposure according to Kimmerle & Trepper.
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: Apparatus consists of a cylindrical exposure chamber which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position
- Source and rate of air: 400 L/h
- System of generating particulates/aerosols: A mixture of test substance and air was obtained using a spray-jet. The spray-jet was fed with compressed air from a compressor and with the test article using an infusion pump and a 50 mL syringe.
- Temperature, humidity, pressure in air chamber: 22 +/- 3°C
TEST ATMOSPHERE
- Brief description of analytical method used: GC-analyses of two air samples
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Test substance is of volatile nature at room temperture (vapour pressure 10700 Pa at 20°C). This resulted in an almost complete gas phase in the inhalation chamber after the test substance air mixture escaped from the spray-jet. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1.49 and 7.74 mg/L air (actual concentrations)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations and clinical examiniations: on the day of exposure 5, 15, 30 and 60 min, 3 h and 24 h after end of exposure; during recovery period at least once a day until all symptoms had subsided, thereafter each working day.
Individual body weight: before the exposure and after exposure in weekly intervals; if animals died body weight at time-point of death was recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight gain
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 7.74 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No substance-related intolerance reactions were observed.
- Body weight:
- No inhibition of body weight gain was examined.
- Gross pathology:
- Macroscopic inspection revealed no pathological findings.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
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