Registration Dossier
Registration Dossier
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EC number: 203-090-1 | CAS number: 103-23-1
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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 OTS 798.1150 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Physical state: liquid
- Analytical purity: 99.7%
- Lot/batch No.: #22513
- Stability under test conditions: The stability of the test substance over the study period
has been proven by reanalysis
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding facility Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: approx . 8 - 9 weeks
- Weight at study initiation: 206 gram (females); 284 gram (males)
- Housing:singly in cages type DK III (Becker, Germany).
- Diet: ad libitum
- Water:ad libitum
- Acclimatisation period:at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Air changes (per hr): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Exposure system: Head-nose inhalation system INA 20 (glass-steel construction, BASF Aktiengesellschaft, volume V ~ 55L).
Technical equipment:
piston metering pump KP 2000 (Desaga)
two-component atomizer Mod.970 (stainless steel, Schlick).
aerosol mixing vessel (glass, BASF)
cyclonic separator (glass, BASF).
Flow rate of the test substance to the atomizer: 35.0 ml/h.
Exposure: supply air flow of 1500 L/h, exhaust air flow of 1350 l/h.
Analytical determination method: Gravimetric determination of the inhalation atmosphere concentration.
In addition, particle size was analyzed.
Equipment:
Stack Sampler Mark III (Andersen)
Vacuum Compressed Air Pump (Millipore)
Sampling probe (internal diameter 6.9 mm)
Limiting orifice 3 L/min
Balance: Sartorius M3P and Sartorius LC 1201S. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.7 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period: 14 days.
Clinical examinations: body weight (prior to exposure, after 7 days and after 14 days). Other clinical signs and findings.
Pathology: gross-pathological examination. - Statistics:
- Performance of a Probit analysis.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.7 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- No lethality occured at the tested concentration of 5.7 mg/L during the study period of 14 days. Therefore, the study satisfied the criteria of a limit test (LC50 > 5.7 mg/L).
- Clinical signs:
- other: Clinical examination revealed irregular and accelerated respiration as well as attempts to escape and piloerection. No clinical signs could be detected from post dosing day 5 onward.
- Body weight:
- Body weight development of the animals was not influenced.
- Gross pathology:
- No macroscopic pathological findings were noted in animals examined at the end of the study.
- Other findings:
- Particle size distribution, expressed as mass median aerodynamic diameter (MMAD), was calculated to be 1.4 µm.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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