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Toxicological information

Acute Toxicity: inhalation

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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:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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