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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:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Due to the low vapour pressure, the technically highest attainable concentration is approximately 0.008 mg/L when the test substance is evaporated at 20°C (concentration not determined), which is below cut off values for classification / any limit concentration.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
This test (called inhalation risk test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (20°C). Young adult laboratory rats were purchased from a breeder. In general, the source and strain of the animals were not documented. Several groups of usually 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods (e.g. 3 min, 10 min, 1, 3 or 7 or 8 hours). The exposure time not causing lethality was usually tested twice. No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure. Group-wise documentation of clinical signs was performed over the 7- to 14-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance. The exposure time causing 50% lethality (LT50) can be estimated from such a study as described for the LD50. Furthermore, using the nominal concentration, vapor pressure and LT50, in many cases a 4-hour LC50 can be estimated using Haber’s law.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: 1-(2-hydroxyethyl)pyrrolidone-2
Test substance number: XIX/367

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the atmosphere was saturated with vapors of the volatile components of the test substance (at 20°C). Vapors were generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
highest attainable concentration when the test substance is evaporated at 20°C: 0.008 mg/L
No. of animals per sex per dose:
12
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LC50
Effect level:
> 0.008 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Mortality:
No mortality was observed.
Clinical signs:
No abnormalities detected.
Body weight:
No detials given in study report.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion