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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not compliant with any guidelines or GLP; endpoint sufficient for hazard classification
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test animals were exposed to vapours of the test substance via whole body exposure for up to 8 hours. The duration of exposure was varied while atmosphere concentration was maintained at constant level.
The assays included in the paper are all intended to provided initial screening information and so do not comply with the requirements of test guidelines subsequently published
GLP compliance:
no
Remarks:
conducted prior to adoption of GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
1-Octanal
IUPAC Name:
1-Octanal
Constituent 2
Chemical structure
Reference substance name:
Octanal
EC Number:
204-683-8
EC Name:
Octanal
Cas Number:
124-13-0
Molecular formula:
C8H16O
IUPAC Name:
octanal
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 1-Octanal

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not documented
- Age at study initiation: Not documented
- Weight at study initiation: Not documented
- Fasting period before study: Not documented
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: To: Not documented

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: dried air
Details on inhalation exposure:
The vapour-air mixture was generated by passing 2.5 litres/minute of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 ml of the test chemical contained in a gas-washing bottle. Inhalations were continued for time periods in a logarithmic series with a ratio of two extending from one-fourth to eight hours, until the inhalation period killing about half the number of rats within 14 days was defined. For inhalation periods of ten, five and two minutes in duration, a static technique is used whereby 50 to 100 grams of material, spread over a shallow tray 200 square inches in area, was placed in a 120-liter sealed chamber for at least 24 hours. Six rats were then rapidly introduced by means of a drawer-type cage designed to minimize vapor loss.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
> 1 - < 8 h
Concentrations:
No concentration data supplied for the exposure atmosphere. The Table of results indicates the longest exposure period that resulted in full survival was 8 hours for octanal
No. of animals per sex per dose:
6 male test animals
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
Statistics:
No information provided

Results and discussion

Preliminary study:
Not relevant
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
other: survival to end of observation period
Effect level:
other: 8 h exposure resulted in no deaths
Remarks on result:
other: 8 h exposure resulted in no deaths
Sex:
male
Dose descriptor:
LC50
Effect level:
> 830 mg/m³ air (nominal)
Based on:
test mat.
Remarks on result:
other: no mortalities occurred following inhalation exposure at maximum achievable concentration
Mortality:
No information provided - the implication of the tabulated results is that no rats died following an 8 hour exposure
Clinical signs:
other: No information provided
Body weight:
No information provided
Gross pathology:
No information provided
Other findings:
No information provided

Any other information on results incl. tables

No information provided

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, there were no mortalities observed and no adverse effects recorded following whole-body inhalation exposure of albino rats to 1-Octanal for 8 hours. The LC50 was found to be greater than 0.83 g/L (>830 mg/m3) the maximum exposure attainable under the test conditions.

Based on this result, the test substance does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.


Executive summary:

In a study conducted by Smyth et al (1962), the test substance 1-Octanal was examined for its ability to cause toxicity when administered via whole-body inhalation to male albino rats. The test animals were exposed to nominal concentrations of the test substance separated by a logarithmic factor of 2. The test animals were exposed to the test substance via whole-body inhalation for a period of up to 8 hours. They were then observed for 14 days following treatment to determine the effects. Under the conditions of this study, there were no mortalities observed and no adverse effects recorded following whole-body inhalation exposure of albino rats to 1-Octanal. The LC50 is greater than 0.83 g/L (>830 mg/m3).  Based on this result, the test substance does not require classification for acute inhalation toxicity according to Regulation EC No. 1272/2008.