Registration Dossier
Registration Dossier
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EC number: 202-509-5 | CAS number: 96-48-0
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11-Sept-1985 thru 25-Sept-1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to current guideline study performed under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- γ-butyrolactone
- EC Number:
- 202-509-5
- EC Name:
- γ-butyrolactone
- Cas Number:
- 96-48-0
- Molecular formula:
- C4H6O2
- IUPAC Name:
- dihydrofuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): Gamma-butyrolactone
- Molecular formula (if other than submission substance): C4H6O2
- Molecular weight (if other than submission substance): 86.09
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Clear oily liquid
- Physical state: liquid
- Analytical purity: 99.66%
- Impurities (identity and concentrations): no data
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: Charles River Breeding Laboratories (Portage, Michigan)
- Age at study initiation: ca. 7 weeks
- Weight at study initiation: 260-284g (males) / 174-208g (females)
- Fasting period before study: no
- Housing: individually in suspended stainless steel wire meshn cages
- Diet (e.g. ad libitum): Purina Laboratory Certified Roden Chow
- Water (e.g. ad libitum): tap
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - 23.3
- Humidity (%): 35 - 60
- Air changes (per hr): ca. 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- other: vapor / aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: conditioned air
- Details on inhalation exposure:
- Exposure concentration: 5.1 mg/L; Exposure duration: 4 hours; Males and Females: 5/sex; Observation period: 14 days
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- collection in mini-impingers containing propanol-2 and analyzed by GC-FID
- Duration of exposure:
- 4 h
- Concentrations:
- 5.1 mg/L (mean analytical); 10.2 mg/L (nominal)
- 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: Observed daily; weighed pre-exposure and on post-exposure days 2, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, and histopathology
Results and discussion
- Preliminary study:
- LC50 > 5.1 mg/L/4 hour
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 5.1 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- No mortality.
- Clinical signs:
- other: Clinical signs immediately after exposure: prostration, lethargy, hypoactivity, shallow breathing, limb disuse, discharge from nose, temporary reduction in food intake; and hyperactivity on Day 2.
- Body weight:
- Temporary reduction in food intake was observed along with weight loss on Day 2 (3% loss in males, 2% in females) with recovery of weigh gains relative to pre-exposure weights of 8% (males) and 6% (females) on Day 7, and 24% (males) and 19% (females) on Day 14.
- Gross pathology:
- No Gross Necropsy Alterations in any of the 10 test animales examined.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
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