Octanal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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, but endpoint sufficient for hazard classification purposes.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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 substance was administered to male rats in a single dose via oral gavage to determine toxicity. 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

Test material information

Constituent 1

Reference substance name:

1-Octanal

IUPAC Name:

1-Octanal

Constituent 2

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: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellon Institute
- Age at study initiation: 4 to 5 weeks of age
- Weight at study initiation: 90 to 120 grams
- Fasting period before study: No fasting period as test animals were non-fasted on administration of the test substance.
- Housing: Not documented
- Diet (e.g. ad libitum): Rockland rat diet, complete, ad libitum
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
No details provided in publication

IN-LIFE DATES: No details provided in publication

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Not documented, although the dosages are arranged in a logarithmic series differing by a factor of 2.

DOSAGE PREPARATION (if unusual): No information provided for octanal. Where lower concentrations were required the test material was diluted with water, corn oil or semi-solid agar.

Doses:

Not documented, although the dosages are arranged in a logarithmic series differing by a factor of 2.

No. of animals per sex per dose:

5 male rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No information provided
- 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

5.63 mL/kg bw

Based on:

not specified

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

4 617 mg/kg bw

Remarks on result:

other: The mg/kg dose was estimated based on the Specific Gravity value of 0.82 g/mL

Mortality:

No mortalities were observed.

Clinical signs:

other: No information provided

Gross pathology:

No information provided

Other findings:

No additional 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, the LD50 for octanal was calculated to be 5.63 ml/kg bw, which is equivalent to 4617 mg/kg bw. Based on this result, the test substance does not warrant any classification in accordance with Regulation EC No. 1272/2008.

Executive summary:

In a study conducted by Smyth et al, (1962), the test substance 1-Octanal, was examined for its ability to cause acute toxicity when administered via oral gavage. The test substance was administered to 5 male non-fasted Carworth-Wistar rats in dosages administered in a logarithmic series differing by a factor of 2. The test animals were observed for 14 days following administration. Under the conditions of this study, the LD50 of the test substance was determined to be 5.63 ml/kg bw which is equivalent to 4617 mg/kg bw. Based on this result, 1-octanal does not warrant any classification for acute oral toxicity in accordance with Regulation EC No. 1272/2008.