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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not available, publication received 1945-05-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not available, publication received 1945-05-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The purpose of this investigation was to determine the effects resulting from the inhalation of an atmosphere saturated with the vapor and containing in addition droplets of the compound in the form of a mist.

- Short description of test conditions: Mice were exposed to a mixture of vapor and mist of the test item in air for 7 hours daily for several days. No details about sex, environmental conditions or MMAD/GSD are given.

- Parameters analysed / observed: Clinical signs and body weights
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no
Specific details on test material used for the study:
No details given
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mice were purchased from a local breeder

IN-LIFE DATES: From day 0 to day 4 (1st experiment), from day 0 up to day 92 (2nd experiment)
Route of administration:
inhalation: mixture of vapour and aerosol / mist
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Air was passed through a tower containing calcium chloride, the air flow is then measured by a rotameter, the air was further passed over the test item heated in a volatilizer and finally into the exposure chamber.
- Exposure chamber volume: 388 Liter
- Method of holding animals in test chamber: In cages
- Source and rate of air: 15 Liters per minute
- Method of conditioning air: Heating and volatilizing of the test item
- Treatment of exhaust air: The air was expelled from the cage through stack opening under a hood.
- Temperature in air chamber: 24-28°C

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: Air samples were mixed with ethyl alcohol. A saturated solution of hydroxylamine hydrochloride (~7%) in 95% ethyl alcohol was added, followed by a 20% KOH solution. The mixture was heated and cooled down. afterwards HCl was added. The transmission of light at 490 µm of the solution was compared with those of water in a photoelectric colorimeter.

- Samples taken from breathing zone: No
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
7 h
Remarks on duration:
1st experiment: 7 hours exposure/day for 4 successive days
2nd experiment: 7 hours exposure/day on successive days (Saturdays and Sundays excepted). Those that survived were so exposed on 60 days over a total period of 92 days.
Concentrations:
Between 3 and 10 mg/L (1st experiment) and approx. 1.5 mg/L (2nd experiment)
No. of animals per sex per dose:
1st experiment: 4 mice
2nd experiment: 6 mice
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 4 days (1st experiment), up to 92 days (2nd experiment)
- Necropsy of survivors performed: No
- Examinations performed: Clinical signs, body weight
Statistics:
No statistics available
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 10 000 mg/m³ air
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
1st experiment
1/4 mice died after first exposure, 2/4 mice died after second exposure and 1/4 mice died after the the fourth exposure

2nd experiment
1 mouse died during the second exposure, 2 mice died during the third exposure
Clinical signs:
irregular respiration
Body weight:
No information given
Gross pathology:
No information given
Other findings:
1st experiment
- Mice: Signs of respiratory disturbance, complete paralysis of the hind quarters

2nd experiment
- Mice: Signs of respiratory disturbance, no weight gain
Interpretation of results:
GHS criteria not met

Data source

Reference
Reference Type:
publication
Title:
Observations on the effects of gamma-valerolactone upon experimental animals
Author:
Deichmann WM. B., Hirose R., Witherup S.
Year:
1945
Bibliographic source:
Journal of industrial hygiene and toxicology, 27: No. 9
Report date:
1945

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The purpose of this investigation was to determine the effects resulting from the inhalation of an atmosphere saturated with the vapor and containing in addition droplets of the compound in the form of a mist.

- Short description of test conditions: Rats were exposed to a mixture of vapor and mist of the test item in air for 7 hours daily for several days. No details about sex, environmental conditions or MMAD/GSD are given.

- Parameters analysed / observed: Clinical signs and body weights
GLP compliance:
not specified
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
γ-valerolactone
EC Number:
203-569-5
EC Name:
γ-valerolactone
Cas Number:
108-29-2
Molecular formula:
C5H8O2
IUPAC Name:
5-methyloxolan-2-one
Specific details on test material used for the study:
No details given

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
IN-LIFE DATES: From day 0 to day 4 (1st experiment), from day 0 up to day 92 (2nd experiment)

Administration / exposure

Route of administration:
inhalation: mixture of vapour and aerosol / mist
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Air was passed through a tower containing calcium chloride, the air flow is then measured by a rotameter, the air was further passed over the test item heated in a volatilizer and finally into the exposure chamber.
- Exposure chamber volume: 388 Liter
- Method of holding animals in test chamber: In cages
- Source and rate of air: 15 Liters per minute
- Method of conditioning air: Heating and volatilizing of the test item
- Treatment of exhaust air: The air was expelled from the cage through stack opening under a hood.
- Temperature in air chamber: 24-28°C

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: Air samples were mixed with ethyl alcohol. A saturated solution of hydroxylamine hydrochloride (~7%) in 95% ethyl alcohol was added, followed by a 20% KOH solution. The mixture was heated and cooled down. afterwards HCl was added. The transmission of light at 490 µm of the solution was compared with those of water in a photoelectric colorimeter.

- Samples taken from breathing zone: No
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
7 h
Remarks on duration:
1st experiment: 7 hours exposure/day for 4 successive days
2nd experiment: 7 hours exposure/day on successive days (Saturdays and Sundays excepted). Those that survived were so exposed on 60 days over a total period of 92 days.
Concentrations:
Between 3 and 10 mg/L (1st experiment) and approx. 1.5 mg/L (2nd experiment)
No. of animals per sex per dose:
1st experiment: 4 rats
2nd experiment: 4 rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 4 days (1st experiment), upt to 92 days (2nd experiment)
- Necropsy of survivors performed: No
- Examinations performed: Clinical signs, body weight
Statistics:
No statistics available

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 10 000 mg/m³ air
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
1st experiment: No mortality

2nd experiment: No mortality
Body weight:
No information given
Gross pathology:
No information given
Other findings:
1st experiment: No signs of illness

2nd experiment: No signs of illness

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met