Octanal

Endpoint summary

Description of key information

An older published study is available for all three routes of acute toxicity.  The study includes limited methodological information but is considered sufficient for the purposes of hazard classification.The acute oral LD50 of octanal was found to be 4617 mg/kg bw; the acute inhalation LC50 was found to be >0.83 mg/L (LC50 >830 mg/m3, no mortalities occurred); the acute dermal LD50 was found to be 5207 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

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

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

Preliminary study:

Not relevant

Sex:

male

Dose descriptor:

LD50

Effect level:

5.63 mL/kg bw

Based on:

not specified

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

No information provided

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 617 mg/kg bw

Quality of whole database:

The study is sufficient for the purposes of hazard classification.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

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

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

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

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

Preliminary study:

Not relevant

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

No information provided

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

830 mg/m³ air

Quality of whole database:

The study is sufficient for the purposes of hazard classification. LC50 > 830 mg/m3, no mortalities occurred

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test substance was applied to test sites on the shaved trunk of New Zealand White albino rabbits for an exposure period of 24 hours.
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

Species:

rabbit

Strain:

New Zealand White

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: 2.5 to 3.5kg
- 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
No details provided in publication

IN-LIFE DATES: No details provided in publication

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: Entire trunk shaved free of hair
- % coverage: Not documented
- Type of wrap if used: Impervious plastic film

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Up to 20 ml/kg can be aplied by this method but greater volumes cannot be retained suitably on the dorsum

Duration of exposure:

The test animals were exposed to the test substance for a 24 hour contact period.

Doses:

Up to 20 ml/kg

No. of animals per sex per dose:

4 male test animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not documented
- Necropsy of survivors performed: Not documented
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not documented

Statistics:

No information provided

Preliminary study:

Not relevant

Sex:

male

Dose descriptor:

LD50

Effect level:

6.35 mL/kg bw

Based on:

test mat.

95% CL:

> 4.7 - < 8.59

Sex:

male

Dose descriptor:

LD50

Effect level:

5 207 mg/kg bw

Based on:

test mat.

Mortality:

No information provided

Clinical signs:

other: No information provided

Gross pathology:

No information provided

Other findings:

No information provided

No additional information provided

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the LD50 of 1-Octanal, was determined to be 6.35 ml/kg bw which is equivalent to 5207 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) 1-Octanal, was tested for its ability to cause acute dermal toxicity when applied to male New Zealand White albino rabbits. The entire trunk of each test animal was shaved prior to application of the test material and the test substance was applied. An impervious dressing was applied to the test site and remained in place for the 24 hours exposure period. During this exposure period, the test animals were placed in restraint tubes. Following exposure, the test animals were placed in cages for the 14 day observation period. Under the conditions of this study, the LD50 of 1-Octanal, was determined to be 6.35 ml/kg bw, equivalent to 5207 mg/kg bw. Based on this result, the test substance does not warrant classification for acute dermal toxicity in accordance with Regulation EC No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 207 mg/kg bw

Quality of whole database:

The study is sufficient for the purposes of hazard classification.

Additional information

Data for acute oral, dermal and inhalation toxicity are avaialable from a screening study. The acute oral LD50 of octanal was found to be 4617 mg/kg bw; the acute inhalation LC50 was found to be >0.83 mg/L (LC50 >830 mg/m3, no mortalities occurred); the acute dermal LD50 was found to be 5207 mg/kg bw. Octanal is therefore shown to be of low acute toxicity by all routes investigated.

Justification for selection of acute toxicity – oral endpoint

Only one study is available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint

Only one study is available for this endpoint

Justification for selection of acute toxicity – dermal endpoint

Only one study is available for this endpoint

Justification for classification or non-classification

The results of acute oral, dermal and inhalation studies performed using octanal do not trigger classification according to the CLP Regulation.