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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (LC50 not statistically determined, no concentrations and particle size distribution measured, only 6 rats used, sex not specified, reporting not according to test guideline)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
: LC50 not statistically derived, no actual concentrations and particle size distribution measured, only 6 rats used, sex not specified, reporting not according to test guideline
Principles of method if other than guideline:
Pre-guideline study, but method is similar to OECD TG 403. A test with graduate doses (standard test) and an inhalation hazard test were performed.
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeraldehyde
EC Number:
203-784-4
EC Name:
Valeraldehyde
Cas Number:
110-62-3
Molecular formula:
C5H10O
IUPAC Name:
valeraldehyde
Details on test material:
- Name of test material (as cited in study report): Valeraldehyde
- no further information on test substance

Test animals

Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breeding facility
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete, ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Test with graduate doses (standard test)
Test atmosphere was generated by injecting definite amounts of test substance into the flowing stream of breathing air using a suitable proportioning pump.
Inhalation hazard test
Test atmosphere was generated by passing a stream of dried air at 2.5 L/min at room temperature through a fritted glass disc immersed to a depth of at least 1 inch in approximately 50 mL of the test substance contained in a gas washing bottle. Six male or female albino rats were exposed for different exposure times to this atmosphere (flowing stream of air saturated or close to saturation with vapour).
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Remarks on duration:
test with graduate doses
Concentrations:
For the standard test, doses were spaced in a logarithmic series with a factor of 2. Number of doses and individual concentrations are not reported.
For the inhalation hazard test, the test atmosphere was saturated or close to saturation with test substance vapor as indicated by the generation method of test atmosphere (saturated vapor concentration of valeraldehyde: 92 mg/L at 20°C according to Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988)
No. of animals per sex per dose:
six male or female animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
14.3 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: Standard test: at the given dose, 3 of 6 animals died. Dose is converted from ppm as reported by the authors (4000 ppm)
Sex:
not specified
Dose descriptor:
discriminating conc.
Effect level:
ca. 92 mg/L air (nominal)
Exp. duration:
15 min
Remarks on result:
other: Inhalation Hazard Test: as discriminating dose the saturated vapor concentration of test substance is given. Exposure duration is the longest exposurte time resulting in no death
Mortality:
After exposure for 4 hours to a concentration of 4000 ppm test substance (ca. 14.3 mg/L; conversion factor = 3.58, Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 1988), 3 of 6 animals died within 14 days. This concentration is taken as LC50.
For the exposure to (nearly) saturated vapor, the exposure time was restricted to 15 min in order to produce no mortality.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Exposure to valeraldehyde vapor in air at a concentration of 14.3 mg/L (4000 ppm) for 4 hours resulted in the death of 3 out of 6 animals (observation period 14 days). This value indicates LC50 and is taken for interpretation of results according to EU regulations (Regulation (EC) 1272/2008).
Executive summary:

For this acute inhalation toxicity study, a standard graduate dose test and an inhalation hazard test were performed. The observation period for both tests was 14 days.

 

Groups of six albino rats were exposed for 4 hours to graduate doses of valeraldehyde vapor in the breathing atmosphere of test animals. Doses were spaced in a logarithmic series with a factor of 2. Actual concentrations were not measured and individual doses are not reported.

 

In the inhalation hazard test, test animals were exposed for various time periods starting from one forth hour up to 8 hours (if appropriate, spacing factor of 2) to an atmosphere saturated or close to saturation with vapor of valeraldehyde. Actual atmosphere concentrations were not measured but can be estimated to be saturated or close to saturation by the method the atmosphere was generated. Saturated vapor concentration of valeraldehyde at 20°C in air is 92 mg/L (Auer Technikum, Edition 12, Auergesellschaft GmbH, Berlin, 1988).

 

In the standard test, a concentration of 4000 ppm (ca. 14.3 mg/L) caused a mortality of 3 of 6 animals. This concentration represents the LC50.

 

In the inhalation hazard test (saturated vapor), the exposure time was restricted to 15 min in order to produce no mortality.

 

A LC50 value using a statistical method was not determined. But the concentration causing 3 deaths out of 6 animals is considered to represent the LC50. Thus the concentration of 14.3 mg/L (4000 ppm) is taken as LC50 value (Smyth 1969).

 

Standards of the OECD test guideline 403 (Acute Inhalation Toxicity) are only met with restrictions by this investigation (only 6 rats used, sex not specified, no concentrations measured, deficiencies in reporting). Due to the high volatitiy of the test substance, the nominal concentrations are estimated to be close to the actual concentrations.

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