γ-valerolactone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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: oral

Type of information:

experimental study

Adequacy of study:

supporting study

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 immediate toxicity of the test item by oral administration and its effects upon respiration and blood pressure.

- Short description of test conditions: Rabbits were treated with different volumes of the test item by gavage. No details about sex, environmental conditions or time schedule of the experiment are given.

- Parameters analysed / observed: Clinical signs, blood pressure and mortality

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

No details given.

Species:

rabbit

Strain:

other: Albino rabbits

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Albino rabbits were purchased from a local breeder
- Acclimation period: About 2 weeks

IN-LIFE DATES: At least 6 days

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
7 mL/kg bw

Doses:

0.94, 1.4, 2.1, 3.2, 4.7, 7.0 mL/kg bw

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: At least 6 days
- Necropsy of survivors performed: No
- Clinical signs: Locomotor system, state of consciousness, respiration
- Other examinations: Blood pressure was recorded by means of a kymograph

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 606 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Effect level was converted from 2.48 mL/kg bw to 2606 mg/kg bw

Mortality:

0% mortality at 0.94 mL/kg bw, 20% mortality at 1.4 mL/kg bw (survival time 14 hours and 6 days), 30% mortality at 2.1 mL/kg bw (survival time 10 hours to 2 days), 60% mortality at 3.2 mL/kg bw (survival time 8 hours to 3 days), 100% mortality at 4.7 mL/kg bw (survival time 5 hours to 5 days), 100% mortality at 7.0 mL/kg bw (survival time 3-12 hours)

Clinical signs:

other: Clinical signs were marked muscular weakness, mild anesthesia, increase in the rate of respiration, followed by dyspnea and occasionally by mild asphyxial convulsions. Death resulted from combined effects of circulatory and respiratory failure.

Gross pathology:

No information given

Other findings:

No information given

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 its application upon the skin.

- Short description of test conditions: The test substance was applied to the shaved belly of rabbits for 2 hours, the procedure was repeated on several days. No details about sex, environmental and treatment are given.

- Parameters analysed / observed: Local and systemic illness, body weights

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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 information available.

Test animals

Species:

rabbit

Strain:

other: Albino rabbits

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Albino rabbits were purchased from a local breeder
- Acclimation period: About 2 weeks

IN-LIFE DATES: From day 0 to day 45

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing: The test item was washed off the skin with soap and water
- Time after start of exposure: 2 hours

TEST MATERIAL
- Amount applied: 2 mL/kg bw
- Constant volume or concentration used: No
- For solids, paste formed: No

Duration of exposure:

2 hours per exposure, exposure for 33 days over a period of 45 days

Doses:

2 mL/kg bw

No. of animals per sex per dose:

6 animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: Animals were exposed and observed over a period of 45 days.
- Frequency of weighing: At the beginning and end of the exposure period
- Necropsy of survivors performed: No
- Examinations performed: Clinical signs, body weight

Statistics:

No statistics performed

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 102 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Effect level was converted from 2 mL/kg bw to 2102 mg/kg bw

Mortality:

No mortality occured

Clinical signs:

other: None of the animals displayed signs of local or systemic illness. The compound did not produce irritation or damage to the skin of these animals.

Gross pathology:

No gross pathology was performed.

Other findings:

No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met